Trial Outcomes & Findings for Second Line Induction Therapy and Healthy Diet for Patients With Ulcerative Colitis (NCT NCT04505410)
NCT ID: NCT04505410
Last Updated: 2025-02-28
Results Overview
Clinical response will be evaluated using the Simple Clinical Colitis Activity Index (SCCAI). The SCCAI has a total range from 0-19 with a higher score indicating greater disease activity. A clinical response is defined as a SCCAI decrease of ≥3 points from baseline. Therefore, the study team will examine the percentage of patients who achieve 'clinical response', defined by an SCCAI decrease of ≥3 points.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
32 participants
Primary outcome timeframe
8 weeks
Results posted on
2025-02-28
Participant Flow
Participant milestones
| Measure |
Advanced Therapy Plus FMD Group
Participants in this group with UC will start an advanced therapy with the addition of two, five-day cycles of Fast Mimicking Diet (FMD) daily meals on weeks 2 and 6.
Fast Mimicking Diet: FMD is a five day meal plan that includes foods such as soups, snacks, bards, teas and supplements (omega-3 fatty acids) for a total of 66 items per box. The diet is plant-based, gluten free and dairy free without any artificial preservatives, chemicals or biologically active ingredients.
|
Advanced Therapy Only Group (no Diet Intervention)
Participants in this group with UC will initiate an advanced therapy and follow a diet based on dietary tolerances.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
18
|
|
Overall Study
COMPLETED
|
9
|
12
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
Advanced Therapy Plus FMD Group
Participants in this group with UC will start an advanced therapy with the addition of two, five-day cycles of Fast Mimicking Diet (FMD) daily meals on weeks 2 and 6.
Fast Mimicking Diet: FMD is a five day meal plan that includes foods such as soups, snacks, bards, teas and supplements (omega-3 fatty acids) for a total of 66 items per box. The diet is plant-based, gluten free and dairy free without any artificial preservatives, chemicals or biologically active ingredients.
|
Advanced Therapy Only Group (no Diet Intervention)
Participants in this group with UC will initiate an advanced therapy and follow a diet based on dietary tolerances.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
abdominal pain after starting tofacitinib
|
1
|
1
|
|
Overall Study
did not want to follow diet
|
1
|
0
|
|
Overall Study
flare up of ulcerative colitis
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
initiated another diet on their own
|
0
|
2
|
Baseline Characteristics
Second Line Induction Therapy and Healthy Diet for Patients With Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
Advanced Therapy Plus FMD Group
n=14 Participants
Participants in this group with UC will start an advanced therapy for eight consecutive weeks with the addition of two, five-day cycles of Fast Mimicking Diet (FMD) daily meals on weeks 2 and 7.
Fast Mimicking Diet: FMD is a five day meal plan that includes foods such as soups, snacks, bards, teas and supplements (omega-3 fatty acids) for a total of 66 items per box. The diet is plant-based, gluten free and dairy free without any artificial preservatives, chemicals or biologically active ingredients.
|
Advanced Therapy Only Group (no Diet Intervention)
n=18 Participants
Participants in this group with UC will be begin an advanced therapy and consume a a diet based on dietary tolerance.
|
Total
n=32 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
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Simple clinical colitis activity index
|
8.0 units on a scale
n=99 Participants
|
7.0 units on a scale
n=107 Participants
|
7.5 units on a scale
n=206 Participants
|
PRIMARY outcome
Timeframe: 8 weeksClinical response will be evaluated using the Simple Clinical Colitis Activity Index (SCCAI). The SCCAI has a total range from 0-19 with a higher score indicating greater disease activity. A clinical response is defined as a SCCAI decrease of ≥3 points from baseline. Therefore, the study team will examine the percentage of patients who achieve 'clinical response', defined by an SCCAI decrease of ≥3 points.
Outcome measures
| Measure |
Advanced Therapy Plus FMD Group
n=14 Participants
Participants in this group with UC will initiate an advanced therapy for UC for eight consecutive weeks with the addition of two, five-day cycles of Fast Mimicking Diet (FMD) daily meals on weeks 2 and 7.
Type of advanced therapy is decided by the provider as part of the standard of care.
Fast Mimicking Diet: FMD is a five day meal plan that includes foods such as soups, snacks, bards, teas and supplements (omega-3 fatty acids) for a total of 66 items per box. The diet is plant-based, gluten free and dairy free without any artificial preservatives, chemicals or biologically active ingredients.
|
Advanced Therapy Without FMD (Medication Only Group)
n=18 Participants
Participants in this group with UC will initiate an advanced therapy as their standard of care.
Patients will be provided guidance on following a diet based on dietary tolerances.
|
|---|---|---|
|
Percentage of Patients Who Achieved Clinical Response
|
57 percentage of patients
|
35 percentage of patients
|
SECONDARY outcome
Timeframe: baseline, 8 weeksCalprotectin levels were evaluated using fecal samples to compare the levels between the treatment and control arms before (baseline) and after the intervention (at 8 weeks). Fecal calprotectin was measured using a BUHLMANN fCAL ELISA Kit. Unit of measure was micrograms/gram.
Outcome measures
| Measure |
Advanced Therapy Plus FMD Group
n=3 Participants
Participants in this group with UC will initiate an advanced therapy for UC for eight consecutive weeks with the addition of two, five-day cycles of Fast Mimicking Diet (FMD) daily meals on weeks 2 and 7.
Type of advanced therapy is decided by the provider as part of the standard of care.
Fast Mimicking Diet: FMD is a five day meal plan that includes foods such as soups, snacks, bards, teas and supplements (omega-3 fatty acids) for a total of 66 items per box. The diet is plant-based, gluten free and dairy free without any artificial preservatives, chemicals or biologically active ingredients.
|
Advanced Therapy Without FMD (Medication Only Group)
n=5 Participants
Participants in this group with UC will initiate an advanced therapy as their standard of care.
Patients will be provided guidance on following a diet based on dietary tolerances.
|
|---|---|---|
|
Fecal Calprotectin Levels Measured in Micrograms/Gram
Baseline
|
3710 mcg/gram
Interval 456.0 to 30218.0
|
5138 mcg/gram
Interval 836.0 to 31594.0
|
|
Fecal Calprotectin Levels Measured in Micrograms/Gram
Week 8
|
1375 mcg/gram
Interval 170.0 to 11197.0
|
5691 mcg/gram
Interval 926.0 to 34997.0
|
SECONDARY outcome
Timeframe: baseline, 8 weeksComparison of Median C-Reactive Protein (CRP) levels between the treatment and control arms before (baseline) and after the intervention (at 8 weeks) will be evaluated using blood samples, unit of measure was mg/dl
Outcome measures
| Measure |
Advanced Therapy Plus FMD Group
n=6 Participants
Participants in this group with UC will initiate an advanced therapy for UC for eight consecutive weeks with the addition of two, five-day cycles of Fast Mimicking Diet (FMD) daily meals on weeks 2 and 7.
Type of advanced therapy is decided by the provider as part of the standard of care.
Fast Mimicking Diet: FMD is a five day meal plan that includes foods such as soups, snacks, bards, teas and supplements (omega-3 fatty acids) for a total of 66 items per box. The diet is plant-based, gluten free and dairy free without any artificial preservatives, chemicals or biologically active ingredients.
|
Advanced Therapy Without FMD (Medication Only Group)
n=6 Participants
Participants in this group with UC will initiate an advanced therapy as their standard of care.
Patients will be provided guidance on following a diet based on dietary tolerances.
|
|---|---|---|
|
CRP Levels Measured in mg/dl
Baseline
|
0.45 mg/dl
Interval 0.33 to 0.73
|
2.10 mg/dl
Interval 1.25 to 3.33
|
|
CRP Levels Measured in mg/dl
Week 8
|
0.09 mg/dl
Interval 0.09 to 0.25
|
1.10 mg/dl
Interval 0.53 to 2.73
|
Adverse Events
Advanced Therapy Plus FMD Group (Diet Intervention)
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Advanced Therapy Only Group (no Diet Intervention)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Advanced Therapy Plus FMD Group (Diet Intervention)
n=14 participants at risk
Participants in this group with UC consuming a standard, regular low-fiber diet will start an advanced therapy for eight consecutive weeks with the addition of two, five-day cycles of Fast Mimicking Diet (FMD) daily meals on weeks 2 and 6.
Medications started have been described previously.
Fast Mimicking Diet: FMD is a five day meal plan that includes foods such as soups, snacks, bards, teas and supplements (omega-3 fatty acids) for a total of 66 items per box. The diet is plant-based, gluten free and dairy free without any artificial preservatives, chemicals or biologically active ingredients.
|
Advanced Therapy Only Group (no Diet Intervention)
n=18 participants at risk
Participants in this group with UC consuming a standard, regular low-fiber diet will be starting an advanced therapy (but not diet intervention).
Medications started have been described previously.
|
|---|---|---|
|
Immune system disorders
Hospitalization
|
14.3%
2/14 • Number of events 2 • 8 weeks
Any serious adverse event was reported to the sponsor of the study (Pfizer) and to the IRB. Pfizer funded this PI-initiated study. Non-serious events were recorded by our team and followed up on.
|
0.00%
0/18 • 8 weeks
Any serious adverse event was reported to the sponsor of the study (Pfizer) and to the IRB. Pfizer funded this PI-initiated study. Non-serious events were recorded by our team and followed up on.
|
Other adverse events
| Measure |
Advanced Therapy Plus FMD Group (Diet Intervention)
n=14 participants at risk
Participants in this group with UC consuming a standard, regular low-fiber diet will start an advanced therapy for eight consecutive weeks with the addition of two, five-day cycles of Fast Mimicking Diet (FMD) daily meals on weeks 2 and 6.
Medications started have been described previously.
Fast Mimicking Diet: FMD is a five day meal plan that includes foods such as soups, snacks, bards, teas and supplements (omega-3 fatty acids) for a total of 66 items per box. The diet is plant-based, gluten free and dairy free without any artificial preservatives, chemicals or biologically active ingredients.
|
Advanced Therapy Only Group (no Diet Intervention)
n=18 participants at risk
Participants in this group with UC consuming a standard, regular low-fiber diet will be starting an advanced therapy (but not diet intervention).
Medications started have been described previously.
|
|---|---|---|
|
Immune system disorders
abdominal pain
|
7.1%
1/14 • Number of events 1 • 8 weeks
Any serious adverse event was reported to the sponsor of the study (Pfizer) and to the IRB. Pfizer funded this PI-initiated study. Non-serious events were recorded by our team and followed up on.
|
11.1%
2/18 • Number of events 2 • 8 weeks
Any serious adverse event was reported to the sponsor of the study (Pfizer) and to the IRB. Pfizer funded this PI-initiated study. Non-serious events were recorded by our team and followed up on.
|
Additional Information
Associate Professor, Director of Translational Studies for the Crohn's and Colitis Center
University of Miami Miller School of Medicine
Phone: 3057733573
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place