Trial Outcomes & Findings for Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Dietary Fiber in Patients With Ulcerative Colitis (NCT NCT03998488)

Last Updated: 2025-01-03

Results Overview

Clinical response at week 8 post-FMT, as defined by the reduction of the Mayo scoring system by \>3 points (+30% reduction) with an accompanying decrease in the sub-score for rectal bleeding of at least 1 point

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

Week 8 post-FMT

Results posted on

2025-01-03

Participant Flow

Participant milestones

Participant milestones
Measure	Investigational FMT Participants will be blindly randomized to receive a single dose of investigational FMT during the week 0 colonoscopy. Additionally, participants will blindly receive a single dose of placebo FMT during the week 8 by flexible sigmoidoscopy. Fecal Microbiota Transplantation: The proposed intervention will deliver 250 milliliters of FMT by colonoscopy to the investigational FMT treatment groups at week 0. The placebo treatment group will instead receive the placebo FMT by colonoscopy at week 0 and then the investigational FMT by flexible sigmoidoscopy at week 8. Investigational FMT is biologically active human fecal material that is pre-screened, tested, quarantined, stored, packaged, and labeled by OpenBiome. Placebo FMP250 is a control unit made of glycerol, saline, and food dye that is stored, packaged, and labeled identically to the investigational FMT, to ensure blinding during delivery.	Investigational FMT + Psyllium Fiber Participants will be blindly randomized to receive a single dose of investigational FMT during the week 0 colonoscopy. They will also receive fiber supplementation of 1 teaspoon 2x/day for 8 weeks. Additionally, participants will blindly receive a single dose of placebo FMT during the week 8 by flexible sigmoidoscopy. Fecal Microbiota Transplantation: The proposed intervention will deliver 250 milliliters of FMT by colonoscopy to the investigational FMT treatment groups at week 0. The placebo treatment group will instead receive the placebo FMT by colonoscopy at week 0 and then the investigational FMT by flexible sigmoidoscopy at week 8. Investigational FMT is biologically active human fecal material that is pre-screened, tested, quarantined, stored, packaged, and labeled by OpenBiome. Placebo FMP250 is a control unit made of glycerol, saline, and food dye that is stored, packaged, and labeled identically to the investigational FMT, to ensure blinding during delivery. Psyllium Husk Powder: All subjects assigned to the fiber treatment arms will be required to take 1 teaspoon (approximately 5 grams) of psyllium husk powder twice a day (morning and night) for 8 weeks, beginning 3 days prior to Week 0 screening colonoscopy. Psyllium husk powder is the dried and powdered form of a psyllium seed coat.	Placebo FMT +/- Psyllium Fiber Participants will be blindly randomized to receive a single dose of placebo FMT during the week 0 colonoscopy. They may or may not also receive fiber supplementation of 1 teaspoon 2x/day for 8 weeks. Additionally, participants will blindly receive a single dose of investigational FMT during the week 8 by flexible sigmoidoscopy. Psyllium Husk Powder: All subjects assigned to the fiber treatment arms will be required to take 1 teaspoon (approximately 5 grams) of psyllium husk powder twice a day (morning and night) for 8 weeks, beginning 3 days prior to Week 0 screening colonoscopy. Psyllium husk powder is the dried and powdered form of a psyllium seed coat.
Week 8 Colonoscopy STARTED	9	9	9
Week 8 Colonoscopy COMPLETED	8	6	8
Week 8 Colonoscopy NOT COMPLETED	1	3	1
Follow Up STARTED	9	9	9
Follow Up COMPLETED	9	9	9
Follow Up NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Dietary Fiber in Patients With Ulcerative Colitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Investigational FMT n=9 Participants Participants will be blindly randomized to receive a single dose of investigational FMT during the week 0 colonoscopy. Additionally, participants will blindly receive a single dose of placebo FMT during the week 8 by flexible sigmoidoscopy. Fecal Microbiota Transplantation: The proposed intervention will deliver 250 milliliters of FMT by colonoscopy to the investigational FMT treatment groups at week 0. The placebo treatment group will instead receive the placebo FMT by colonoscopy at week 0 and then the investigational FMT by flexible sigmoidoscopy at week 8. Investigational FMT is biologically active human fecal material that is pre-screened, tested, quarantined, stored, packaged, and labeled by OpenBiome. Placebo FMP250 is a control unit made of glycerol, saline, and food dye that is stored, packaged, and labeled identically to the investigational FMT, to ensure blinding during delivery.	Investigational FMT + Psyllium Fiber n=9 Participants Participants will be blindly randomized to receive a single dose of investigational FMT during the week 0 colonoscopy. They will also receive fiber supplementation of 1 teaspoon 2x/day for 8 weeks. Additionally, participants will blindly receive a single dose of placebo FMT during the week 8 by flexible sigmoidoscopy. Fecal Microbiota Transplantation: The proposed intervention will deliver 250 milliliters of FMT by colonoscopy to the investigational FMT treatment groups at week 0. The placebo treatment group will instead receive the placebo FMT by colonoscopy at week 0 and then the investigational FMT by flexible sigmoidoscopy at week 8. Investigational FMT is biologically active human fecal material that is pre-screened, tested, quarantined, stored, packaged, and labeled by OpenBiome. Placebo FMP250 is a control unit made of glycerol, saline, and food dye that is stored, packaged, and labeled identically to the investigational FMT, to ensure blinding during delivery. Psyllium Husk Powder: All subjects assigned to the fiber treatment arms will be required to take 1 teaspoon (approximately 5 grams) of psyllium husk powder twice a day (morning and night) for 8 weeks, beginning 3 days prior to Week 0 screening colonoscopy. Psyllium husk powder is the dried and powdered form of a psyllium seed coat.	Placebo FMT +/- Psyllium Fiber n=9 Participants Participants will be blindly randomized to receive a single dose of placebo FMT during the week 0 colonoscopy. They may or may not also receive fiber supplementation of 1 teaspoon 2x/day for 8 weeks. Additionally, participants will blindly receive a single dose of investigational FMT during the week 8 by flexible sigmoidoscopy. Psyllium Husk Powder: All subjects assigned to the fiber treatment arms will be required to take 1 teaspoon (approximately 5 grams) of psyllium husk powder twice a day (morning and night) for 8 weeks, beginning 3 days prior to Week 0 screening colonoscopy. Psyllium husk powder is the dried and powdered form of a psyllium seed coat.	Total n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=99 Participants	8 Participants n=107 Participants	8 Participants n=206 Participants	25 Participants n=7 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants	2 Participants n=7 Participants
Sex: Female, Male Female	3 Participants n=99 Participants	3 Participants n=107 Participants	2 Participants n=206 Participants	8 Participants n=7 Participants
Sex: Female, Male Male	6 Participants n=99 Participants	6 Participants n=107 Participants	7 Participants n=206 Participants	19 Participants n=7 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	1 Participants n=7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=99 Participants	9 Participants n=107 Participants	8 Participants n=206 Participants	26 Participants n=7 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants
Race (NIH/OMB) White	8 Participants n=99 Participants	9 Participants n=107 Participants	8 Participants n=206 Participants	25 Participants n=7 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	1 Participants n=7 Participants
Region of Enrollment United States	9 participants n=99 Participants	9 participants n=107 Participants	9 participants n=206 Participants	27 participants n=7 Participants

PRIMARY outcome

Timeframe: Week 8 post-FMT

Population: Analysis will be performed based on intent to treat. Therefore, any subjects with missing primary endpoint data at week 8 will have their baseline Mayo score carried forward to remain the same for the week 8 primary endpoint.

Outcome measures

Outcome measures
Measure	Investigational FMT n=9 Participants Participants will be blindly randomized to receive a single dose of investigational FMT during the week 0 colonoscopy. Additionally, participants will blindly receive a single dose of placebo FMT during the week 8 by flexible sigmoidoscopy. Fecal Microbiota Transplantation: The proposed intervention will deliver 250 milliliters of FMT by colonoscopy to the investigational FMT treatment groups at week 0. The placebo treatment group will instead receive the placebo FMT by colonoscopy at week 0 and then the investigational FMT by flexible sigmoidoscopy at week 8. Investigational FMT is biologically active human fecal material that is pre-screened, tested, quarantined, stored, packaged, and labeled by OpenBiome. Placebo FMP250 is a control unit made of glycerol, saline, and food dye that is stored, packaged, and labeled identically to the investigational FMT, to ensure blinding during delivery.	Investigational FMT + Psyllium Fiber n=9 Participants Participants will be blindly randomized to receive a single dose of investigational FMT during the week 0 colonoscopy. They will also receive fiber supplementation of 1 teaspoon 2x/day for 8 weeks. Additionally, participants will blindly receive a single dose of placebo FMT during the week 8 by flexible sigmoidoscopy. Fecal Microbiota Transplantation: The proposed intervention will deliver 250 milliliters of FMT by colonoscopy to the investigational FMT treatment groups at week 0. The placebo treatment group will instead receive the placebo FMT by colonoscopy at week 0 and then the investigational FMT by flexible sigmoidoscopy at week 8. Investigational FMT is biologically active human fecal material that is pre-screened, tested, quarantined, stored, packaged, and labeled by OpenBiome. Placebo FMP250 is a control unit made of glycerol, saline, and food dye that is stored, packaged, and labeled identically to the investigational FMT, to ensure blinding during delivery. Psyllium Husk Powder: All subjects assigned to the fiber treatment arms will be required to take 1 teaspoon (approximately 5 grams) of psyllium husk powder twice a day (morning and night) for 8 weeks, beginning 3 days prior to Week 0 screening colonoscopy. Psyllium husk powder is the dried and powdered form of a psyllium seed coat.	Placebo FMT +/- Psyllium Fiber n=9 Participants Participants will be blindly randomized to receive a single dose of placebo FMT during the week 0 colonoscopy. They may or may not also receive fiber supplementation of 1 teaspoon 2x/day for 8 weeks. Additionally, participants will blindly receive a single dose of investigational FMT during the week 8 by flexible sigmoidoscopy. Psyllium Husk Powder: All subjects assigned to the fiber treatment arms will be required to take 1 teaspoon (approximately 5 grams) of psyllium husk powder twice a day (morning and night) for 8 weeks, beginning 3 days prior to Week 0 screening colonoscopy. Psyllium husk powder is the dried and powdered form of a psyllium seed coat.
Clinical Response	5 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 8 post-FMT

Population: Analysis will be performed based on intent to treat. Therefore, any subjects with missing data at week 8 will have their baseline Mayo score carried forward to remain the same for the evaluation of clinical remission at week 8.

Clinical remission at week 8 post-FMT, as defined by Mayo score ≤ 2 without any subscore \>1

Outcome measures

Outcome measures
Measure	Investigational FMT n=9 Participants Participants will be blindly randomized to receive a single dose of investigational FMT during the week 0 colonoscopy. Additionally, participants will blindly receive a single dose of placebo FMT during the week 8 by flexible sigmoidoscopy. Fecal Microbiota Transplantation: The proposed intervention will deliver 250 milliliters of FMT by colonoscopy to the investigational FMT treatment groups at week 0. The placebo treatment group will instead receive the placebo FMT by colonoscopy at week 0 and then the investigational FMT by flexible sigmoidoscopy at week 8. Investigational FMT is biologically active human fecal material that is pre-screened, tested, quarantined, stored, packaged, and labeled by OpenBiome. Placebo FMP250 is a control unit made of glycerol, saline, and food dye that is stored, packaged, and labeled identically to the investigational FMT, to ensure blinding during delivery.	Investigational FMT + Psyllium Fiber n=9 Participants Participants will be blindly randomized to receive a single dose of investigational FMT during the week 0 colonoscopy. They will also receive fiber supplementation of 1 teaspoon 2x/day for 8 weeks. Additionally, participants will blindly receive a single dose of placebo FMT during the week 8 by flexible sigmoidoscopy. Fecal Microbiota Transplantation: The proposed intervention will deliver 250 milliliters of FMT by colonoscopy to the investigational FMT treatment groups at week 0. The placebo treatment group will instead receive the placebo FMT by colonoscopy at week 0 and then the investigational FMT by flexible sigmoidoscopy at week 8. Investigational FMT is biologically active human fecal material that is pre-screened, tested, quarantined, stored, packaged, and labeled by OpenBiome. Placebo FMP250 is a control unit made of glycerol, saline, and food dye that is stored, packaged, and labeled identically to the investigational FMT, to ensure blinding during delivery. Psyllium Husk Powder: All subjects assigned to the fiber treatment arms will be required to take 1 teaspoon (approximately 5 grams) of psyllium husk powder twice a day (morning and night) for 8 weeks, beginning 3 days prior to Week 0 screening colonoscopy. Psyllium husk powder is the dried and powdered form of a psyllium seed coat.	Placebo FMT +/- Psyllium Fiber n=9 Participants Participants will be blindly randomized to receive a single dose of placebo FMT during the week 0 colonoscopy. They may or may not also receive fiber supplementation of 1 teaspoon 2x/day for 8 weeks. Additionally, participants will blindly receive a single dose of investigational FMT during the week 8 by flexible sigmoidoscopy. Psyllium Husk Powder: All subjects assigned to the fiber treatment arms will be required to take 1 teaspoon (approximately 5 grams) of psyllium husk powder twice a day (morning and night) for 8 weeks, beginning 3 days prior to Week 0 screening colonoscopy. Psyllium husk powder is the dried and powdered form of a psyllium seed coat.
Clinical Remission	3 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 8 post-FMT

Endoscopic response or remission at week 8 post-FMT, as defined by a Mayo endoscopic sub-score 0-1 with at least a 1-point reduction from baseline or a Mayo endoscopic sub-score of 0

Outcome measures

Outcome measures
Measure	Investigational FMT n=9 Participants Participants will be blindly randomized to receive a single dose of investigational FMT during the week 0 colonoscopy. Additionally, participants will blindly receive a single dose of placebo FMT during the week 8 by flexible sigmoidoscopy. Fecal Microbiota Transplantation: The proposed intervention will deliver 250 milliliters of FMT by colonoscopy to the investigational FMT treatment groups at week 0. The placebo treatment group will instead receive the placebo FMT by colonoscopy at week 0 and then the investigational FMT by flexible sigmoidoscopy at week 8. Investigational FMT is biologically active human fecal material that is pre-screened, tested, quarantined, stored, packaged, and labeled by OpenBiome. Placebo FMP250 is a control unit made of glycerol, saline, and food dye that is stored, packaged, and labeled identically to the investigational FMT, to ensure blinding during delivery.	Investigational FMT + Psyllium Fiber n=9 Participants Participants will be blindly randomized to receive a single dose of investigational FMT during the week 0 colonoscopy. They will also receive fiber supplementation of 1 teaspoon 2x/day for 8 weeks. Additionally, participants will blindly receive a single dose of placebo FMT during the week 8 by flexible sigmoidoscopy. Fecal Microbiota Transplantation: The proposed intervention will deliver 250 milliliters of FMT by colonoscopy to the investigational FMT treatment groups at week 0. The placebo treatment group will instead receive the placebo FMT by colonoscopy at week 0 and then the investigational FMT by flexible sigmoidoscopy at week 8. Investigational FMT is biologically active human fecal material that is pre-screened, tested, quarantined, stored, packaged, and labeled by OpenBiome. Placebo FMP250 is a control unit made of glycerol, saline, and food dye that is stored, packaged, and labeled identically to the investigational FMT, to ensure blinding during delivery. Psyllium Husk Powder: All subjects assigned to the fiber treatment arms will be required to take 1 teaspoon (approximately 5 grams) of psyllium husk powder twice a day (morning and night) for 8 weeks, beginning 3 days prior to Week 0 screening colonoscopy. Psyllium husk powder is the dried and powdered form of a psyllium seed coat.	Placebo FMT +/- Psyllium Fiber n=9 Participants Participants will be blindly randomized to receive a single dose of placebo FMT during the week 0 colonoscopy. They may or may not also receive fiber supplementation of 1 teaspoon 2x/day for 8 weeks. Additionally, participants will blindly receive a single dose of investigational FMT during the week 8 by flexible sigmoidoscopy. Psyllium Husk Powder: All subjects assigned to the fiber treatment arms will be required to take 1 teaspoon (approximately 5 grams) of psyllium husk powder twice a day (morning and night) for 8 weeks, beginning 3 days prior to Week 0 screening colonoscopy. Psyllium husk powder is the dried and powdered form of a psyllium seed coat.
Endoscopic Response or Remission	4 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 0 Colonoscopy - Week 12 post-FMT, 6 months post-FMT, and 1 year post-FMT

Adverse event counts are cumulative frequencies of adverse and severe adverse events assessed at Week 0 Colonoscopy - Week 12 post-FMT, 6 months post-FMT, and 1 year post-FMT.

Outcome measures

Outcome measures
Measure	Investigational FMT n=9 Participants Participants will be blindly randomized to receive a single dose of investigational FMT during the week 0 colonoscopy. Additionally, participants will blindly receive a single dose of placebo FMT during the week 8 by flexible sigmoidoscopy. Fecal Microbiota Transplantation: The proposed intervention will deliver 250 milliliters of FMT by colonoscopy to the investigational FMT treatment groups at week 0. The placebo treatment group will instead receive the placebo FMT by colonoscopy at week 0 and then the investigational FMT by flexible sigmoidoscopy at week 8. Investigational FMT is biologically active human fecal material that is pre-screened, tested, quarantined, stored, packaged, and labeled by OpenBiome. Placebo FMP250 is a control unit made of glycerol, saline, and food dye that is stored, packaged, and labeled identically to the investigational FMT, to ensure blinding during delivery.	Investigational FMT + Psyllium Fiber n=9 Participants Participants will be blindly randomized to receive a single dose of investigational FMT during the week 0 colonoscopy. They will also receive fiber supplementation of 1 teaspoon 2x/day for 8 weeks. Additionally, participants will blindly receive a single dose of placebo FMT during the week 8 by flexible sigmoidoscopy. Fecal Microbiota Transplantation: The proposed intervention will deliver 250 milliliters of FMT by colonoscopy to the investigational FMT treatment groups at week 0. The placebo treatment group will instead receive the placebo FMT by colonoscopy at week 0 and then the investigational FMT by flexible sigmoidoscopy at week 8. Investigational FMT is biologically active human fecal material that is pre-screened, tested, quarantined, stored, packaged, and labeled by OpenBiome. Placebo FMP250 is a control unit made of glycerol, saline, and food dye that is stored, packaged, and labeled identically to the investigational FMT, to ensure blinding during delivery. Psyllium Husk Powder: All subjects assigned to the fiber treatment arms will be required to take 1 teaspoon (approximately 5 grams) of psyllium husk powder twice a day (morning and night) for 8 weeks, beginning 3 days prior to Week 0 screening colonoscopy. Psyllium husk powder is the dried and powdered form of a psyllium seed coat.	Placebo FMT +/- Psyllium Fiber n=9 Participants Participants will be blindly randomized to receive a single dose of placebo FMT during the week 0 colonoscopy. They may or may not also receive fiber supplementation of 1 teaspoon 2x/day for 8 weeks. Additionally, participants will blindly receive a single dose of investigational FMT during the week 8 by flexible sigmoidoscopy. Psyllium Husk Powder: All subjects assigned to the fiber treatment arms will be required to take 1 teaspoon (approximately 5 grams) of psyllium husk powder twice a day (morning and night) for 8 weeks, beginning 3 days prior to Week 0 screening colonoscopy. Psyllium husk powder is the dried and powdered form of a psyllium seed coat.
Number of Treatment or Disease Related Adverse Events.	21 Adverse and Severe Adverse Events	33 Adverse and Severe Adverse Events	20 Adverse and Severe Adverse Events

Adverse Events

Investigational FMT

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Investigational FMT + Psyllium Fiber

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo FMT +/- Psyllium Fiber

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Investigational FMT n=9 participants at risk Participants will be blindly randomized to receive a single dose of investigational FMT during the week 0 colonoscopy. Additionally, participants will blindly receive a single dose of placebo FMT during the week 8 by flexible sigmoidoscopy. Fecal Microbiota Transplantation: The proposed intervention will deliver 250 milliliters of FMT by colonoscopy to the investigational FMT treatment groups at week 0. The placebo treatment group will instead receive the placebo FMT by colonoscopy at week 0 and then the investigational FMT by flexible sigmoidoscopy at week 8. Investigational FMT is biologically active human fecal material that is pre-screened, tested, quarantined, stored, packaged, and labeled by OpenBiome. Placebo FMP250 is a control unit made of glycerol, saline, and food dye that is stored, packaged, and labeled identically to the investigational FMT, to ensure blinding during delivery.	Investigational FMT + Psyllium Fiber n=9 participants at risk Participants will be blindly randomized to receive a single dose of investigational FMT during the week 0 colonoscopy. They will also receive fiber supplementation of 1 teaspoon 2x/day for 8 weeks. Additionally, participants will blindly receive a single dose of placebo FMT during the week 8 by flexible sigmoidoscopy. Fecal Microbiota Transplantation: The proposed intervention will deliver 250 milliliters of FMT by colonoscopy to the investigational FMT treatment groups at week 0. The placebo treatment group will instead receive the placebo FMT by colonoscopy at week 0 and then the investigational FMT by flexible sigmoidoscopy at week 8. Investigational FMT is biologically active human fecal material that is pre-screened, tested, quarantined, stored, packaged, and labeled by OpenBiome. Placebo FMP250 is a control unit made of glycerol, saline, and food dye that is stored, packaged, and labeled identically to the investigational FMT, to ensure blinding during delivery. Psyllium Husk Powder: All subjects assigned to the fiber treatment arms will be required to take 1 teaspoon (approximately 5 grams) of psyllium husk powder twice a day (morning and night) for 8 weeks, beginning 3 days prior to Week 0 screening colonoscopy. Psyllium husk powder is the dried and powdered form of a psyllium seed coat.	Placebo FMT +/- Psyllium Fiber n=9 participants at risk Participants will be blindly randomized to receive a single dose of placebo FMT during the week 0 colonoscopy. They may or may not also receive fiber supplementation of 1 teaspoon 2x/day for 8 weeks. Additionally, participants will blindly receive a single dose of investigational FMT during the week 8 by flexible sigmoidoscopy. Psyllium Husk Powder: All subjects assigned to the fiber treatment arms will be required to take 1 teaspoon (approximately 5 grams) of psyllium husk powder twice a day (morning and night) for 8 weeks, beginning 3 days prior to Week 0 screening colonoscopy. Psyllium husk powder is the dried and powdered form of a psyllium seed coat.
Gastrointestinal disorders Worsening ulcerative colitis disease activity	11.1% 1/9 • Number of events 1 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	0.00% 0/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	0.00% 0/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.

Other adverse events

Additional Information

Dr. Randy Longman

Weill Cornell Medicine

Phone: 646-962-6289

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Investigational FMT n=9 participants at risk Participants will be blindly randomized to receive a single dose of investigational FMT during the week 0 colonoscopy. Additionally, participants will blindly receive a single dose of placebo FMT during the week 8 by flexible sigmoidoscopy. Fecal Microbiota Transplantation: The proposed intervention will deliver 250 milliliters of FMT by colonoscopy to the investigational FMT treatment groups at week 0. The placebo treatment group will instead receive the placebo FMT by colonoscopy at week 0 and then the investigational FMT by flexible sigmoidoscopy at week 8. Investigational FMT is biologically active human fecal material that is pre-screened, tested, quarantined, stored, packaged, and labeled by OpenBiome. Placebo FMP250 is a control unit made of glycerol, saline, and food dye that is stored, packaged, and labeled identically to the investigational FMT, to ensure blinding during delivery.	Investigational FMT + Psyllium Fiber n=9 participants at risk Participants will be blindly randomized to receive a single dose of investigational FMT during the week 0 colonoscopy. They will also receive fiber supplementation of 1 teaspoon 2x/day for 8 weeks. Additionally, participants will blindly receive a single dose of placebo FMT during the week 8 by flexible sigmoidoscopy. Fecal Microbiota Transplantation: The proposed intervention will deliver 250 milliliters of FMT by colonoscopy to the investigational FMT treatment groups at week 0. The placebo treatment group will instead receive the placebo FMT by colonoscopy at week 0 and then the investigational FMT by flexible sigmoidoscopy at week 8. Investigational FMT is biologically active human fecal material that is pre-screened, tested, quarantined, stored, packaged, and labeled by OpenBiome. Placebo FMP250 is a control unit made of glycerol, saline, and food dye that is stored, packaged, and labeled identically to the investigational FMT, to ensure blinding during delivery. Psyllium Husk Powder: All subjects assigned to the fiber treatment arms will be required to take 1 teaspoon (approximately 5 grams) of psyllium husk powder twice a day (morning and night) for 8 weeks, beginning 3 days prior to Week 0 screening colonoscopy. Psyllium husk powder is the dried and powdered form of a psyllium seed coat.	Placebo FMT +/- Psyllium Fiber n=9 participants at risk Participants will be blindly randomized to receive a single dose of placebo FMT during the week 0 colonoscopy. They may or may not also receive fiber supplementation of 1 teaspoon 2x/day for 8 weeks. Additionally, participants will blindly receive a single dose of investigational FMT during the week 8 by flexible sigmoidoscopy. Psyllium Husk Powder: All subjects assigned to the fiber treatment arms will be required to take 1 teaspoon (approximately 5 grams) of psyllium husk powder twice a day (morning and night) for 8 weeks, beginning 3 days prior to Week 0 screening colonoscopy. Psyllium husk powder is the dried and powdered form of a psyllium seed coat.
Gastrointestinal disorders Diarrhea	22.2% 2/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	33.3% 3/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	33.3% 3/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.
Gastrointestinal disorders Abdominal Pain	22.2% 2/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	33.3% 3/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	22.2% 2/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.
Gastrointestinal disorders Nausea	22.2% 2/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	22.2% 2/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	22.2% 2/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.
General disorders Fever	11.1% 1/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	33.3% 3/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	22.2% 2/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.
General disorders Fatigue	22.2% 2/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	33.3% 3/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	0.00% 0/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.
Infections and infestations COVID-19 Infection	0.00% 0/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	44.4% 4/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	11.1% 1/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.
General disorders Chills	22.2% 2/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	0.00% 0/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	22.2% 2/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.
Gastrointestinal disorders Bloating	22.2% 2/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	22.2% 2/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	0.00% 0/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.
Gastrointestinal disorders Flatulence	11.1% 1/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	11.1% 1/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	22.2% 2/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.
General disorders Headache	0.00% 0/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	22.2% 2/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	11.1% 1/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.
Gastrointestinal disorders Constipation	11.1% 1/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	22.2% 2/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	0.00% 0/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.
Respiratory, thoracic and mediastinal disorders Congestion	11.1% 1/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	11.1% 1/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	11.1% 1/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.
General disorders Vomiting	11.1% 1/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	11.1% 1/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	11.1% 1/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.
Infections and infestations Yersinia Enterocolitis Infection	0.00% 0/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	22.2% 2/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	0.00% 0/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.
Gastrointestinal disorders Fecal Urgency	11.1% 1/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	0.00% 0/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	11.1% 1/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.
Infections and infestations Urinary Tract Infection	0.00% 0/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	0.00% 0/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	11.1% 1/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.
Infections and infestations Stye Infection	0.00% 0/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	0.00% 0/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	11.1% 1/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.
General disorders Appetite Loss	11.1% 1/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	0.00% 0/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	0.00% 0/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.
General disorders Hypotension	11.1% 1/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	0.00% 0/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	0.00% 0/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.
General disorders Body Aches	0.00% 0/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	11.1% 1/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	0.00% 0/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.
Infections and infestations Enteropathogenic E. Coli Infection	0.00% 0/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	11.1% 1/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	0.00% 0/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.
Infections and infestations Ear Infection	0.00% 0/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	11.1% 1/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	0.00% 0/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.
Infections and infestations Eye Infection	0.00% 0/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	11.1% 1/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.	0.00% 0/9 • Adverse event data was collected up to 12 weeks post-FMT. Serious adverse event data was also collected at 6 months and 1 year.