Trial Outcomes & Findings for FMT in Cirrhosis and Hepatic Encephalopathy (NCT NCT03796598)
NCT ID: NCT03796598
Last Updated: 2025-05-25
Results Overview
Number of patients with serious adverse events between groups related to FMT, especially related to HE
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
60 participants
Primary outcome timeframe
6 months
Results posted on
2025-05-25
Participant Flow
Participant milestones
| Measure |
Placebo
Oral and rectal placebo at visit 2 Oral placebo at day 30
Placebo: Placebo
|
Group 3: Oral Placebo and Rectal FMT
Oral placebo and rectal FMT at visit 2 Oral placebo at day 30
Fecal Microbial Transplant Enema: FMT enema
Placebo: Placebo
|
Group 2: Oral FMT and Rectal Placebo
Oral FMT and rectal placebo at visit 2 Oral FMT at day 30
Fecal Microbial transplant Capsules: Oral capsules of FMT
|
Group 1: Dual Oral and Rectal FMT
Dual Oral and rectal FMT at visit 2 Oral FMT at day 30
Fecal Microbial transplant Capsules: Oral capsules of FMT
Fecal Microbial Transplant Enema: FMT enema
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Placebo
n=15 Participants
Oral and rectal placebo at visit 2 Oral placebo at day 30
Placebo: Placebo
|
Group 3: Oral Placebo and Rectal FMT
n=15 Participants
Oral placebo and rectal FMT at visit 2 Oral placebo at day 30
Fecal Microbial Transplant Enema: FMT enema
Placebo: Placebo
|
Group 2: Oral FMT and Rectal Placebo
n=15 Participants
Oral FMT and rectal placebo at visit 2 Oral FMT at day 30
Fecal Microbial transplant Capsules: Oral capsules of FMT
|
Group 1: Dual Oral and Rectal FMT
n=15 Participants
Dual Oral and rectal FMT at visit 2 Oral FMT at day 30
Fecal Microbial transplant Capsules: Oral capsules of FMT
Fecal Microbial Transplant Enema: FMT enema
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63.4 years
STANDARD_DEVIATION 7.5 • n=15 Participants
|
60.6 years
STANDARD_DEVIATION 10.3 • n=15 Participants
|
63.0 years
STANDARD_DEVIATION 11.7 • n=15 Participants
|
65.0 years
STANDARD_DEVIATION 7.1 • n=15 Participants
|
63.0 years
STANDARD_DEVIATION 9.2 • n=60 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=15 Participants
|
1 Participants
n=15 Participants
|
3 Participants
n=15 Participants
|
5 Participants
n=15 Participants
|
12 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=15 Participants
|
14 Participants
n=15 Participants
|
12 Participants
n=15 Participants
|
10 Participants
n=15 Participants
|
48 Participants
n=60 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
60 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: number of patients
Number of patients with serious adverse events between groups related to FMT, especially related to HE
Outcome measures
| Measure |
Placebo
n=15 Participants
Oral and rectal placebo at visit 2 Oral placebo at day 30
Placebo: Placebo
|
Group 3: Oral Placebo and Rectal FMT
n=15 Participants
Oral placebo and rectal FMT at visit 2 Oral placebo at day 30
Fecal Microbial Transplant Enema: FMT enema
Placebo: Placebo
|
Group 2: Oral FMT and Rectal Placebo
n=15 Participants
Oral FMT and rectal placebo at visit 2 Oral FMT at day 30
Fecal Microbial transplant Capsules: Oral capsules of FMT
|
Group 1: Dual Oral and Rectal FMT
n=15 Participants
Dual Oral and rectal FMT at visit 2 Oral FMT at day 30
Fecal Microbial transplant Capsules: Oral capsules of FMT
Fecal Microbial Transplant Enema: FMT enema
|
|---|---|---|---|---|
|
Serious Adverse Events Related to FMT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsNumber of patients with adverse events that do not fit the criteria of serious adverse events between groups related to FMT
Outcome measures
| Measure |
Placebo
n=15 Participants
Oral and rectal placebo at visit 2 Oral placebo at day 30
Placebo: Placebo
|
Group 3: Oral Placebo and Rectal FMT
n=15 Participants
Oral placebo and rectal FMT at visit 2 Oral placebo at day 30
Fecal Microbial Transplant Enema: FMT enema
Placebo: Placebo
|
Group 2: Oral FMT and Rectal Placebo
n=15 Participants
Oral FMT and rectal placebo at visit 2 Oral FMT at day 30
Fecal Microbial transplant Capsules: Oral capsules of FMT
|
Group 1: Dual Oral and Rectal FMT
n=15 Participants
Dual Oral and rectal FMT at visit 2 Oral FMT at day 30
Fecal Microbial transplant Capsules: Oral capsules of FMT
Fecal Microbial Transplant Enema: FMT enema
|
|---|---|---|---|---|
|
Adverse Events Related to FMT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsShannon diversity index compared to baseline and engraftment related to the donor at baseline, within 30 days and then monthly till 6 months. Ranges usually from 0-10, higher values represent a better diversity. There are no maximum values.
Outcome measures
| Measure |
Placebo
n=15 Participants
Oral and rectal placebo at visit 2 Oral placebo at day 30
Placebo: Placebo
|
Group 3: Oral Placebo and Rectal FMT
n=14 Participants
Oral placebo and rectal FMT at visit 2 Oral placebo at day 30
Fecal Microbial Transplant Enema: FMT enema
Placebo: Placebo
|
Group 2: Oral FMT and Rectal Placebo
n=14 Participants
Oral FMT and rectal placebo at visit 2 Oral FMT at day 30
Fecal Microbial transplant Capsules: Oral capsules of FMT
|
Group 1: Dual Oral and Rectal FMT
n=14 Participants
Dual Oral and rectal FMT at visit 2 Oral FMT at day 30
Fecal Microbial transplant Capsules: Oral capsules of FMT
Fecal Microbial Transplant Enema: FMT enema
|
|---|---|---|---|---|
|
Change in Microbial Diversity in Stool
|
1.45 units on a scale
Standard Deviation 0.37
|
1.46 units on a scale
Standard Deviation 0.33
|
1.71 units on a scale
Standard Deviation 0.33
|
1.53 units on a scale
Standard Deviation 0.72
|
SECONDARY outcome
Timeframe: 30 days and 6 monthsQuality of life assessment change defined by Sickness Impact Profile total score at 30 days and 6 months between groups. This is a percentage result ranges usually from 0-100. A higher score indicates worse quality of life related to the participant's health within 24 hours.
Outcome measures
| Measure |
Placebo
n=14 Participants
Oral and rectal placebo at visit 2 Oral placebo at day 30
Placebo: Placebo
|
Group 3: Oral Placebo and Rectal FMT
n=14 Participants
Oral placebo and rectal FMT at visit 2 Oral placebo at day 30
Fecal Microbial Transplant Enema: FMT enema
Placebo: Placebo
|
Group 2: Oral FMT and Rectal Placebo
n=14 Participants
Oral FMT and rectal placebo at visit 2 Oral FMT at day 30
Fecal Microbial transplant Capsules: Oral capsules of FMT
|
Group 1: Dual Oral and Rectal FMT
n=14 Participants
Dual Oral and rectal FMT at visit 2 Oral FMT at day 30
Fecal Microbial transplant Capsules: Oral capsules of FMT
Fecal Microbial Transplant Enema: FMT enema
|
|---|---|---|---|---|
|
Sickness Impact Profile Change
|
9.63 units on a scale
Interval 3.0 to 21.0
|
15.62 units on a scale
Interval 7.94 to 24.49
|
18.15 units on a scale
Interval 8.78 to 23.59
|
15.94 units on a scale
Interval 13.04 to 26.65
|
SECONDARY outcome
Timeframe: 60 daysCognitive assessment change using the Psychometric hepatic encephalopathy score between groups at 60 days Range is -15 to +5 and higher is better
Outcome measures
| Measure |
Placebo
n=14 Participants
Oral and rectal placebo at visit 2 Oral placebo at day 30
Placebo: Placebo
|
Group 3: Oral Placebo and Rectal FMT
n=14 Participants
Oral placebo and rectal FMT at visit 2 Oral placebo at day 30
Fecal Microbial Transplant Enema: FMT enema
Placebo: Placebo
|
Group 2: Oral FMT and Rectal Placebo
n=14 Participants
Oral FMT and rectal placebo at visit 2 Oral FMT at day 30
Fecal Microbial transplant Capsules: Oral capsules of FMT
|
Group 1: Dual Oral and Rectal FMT
n=14 Participants
Dual Oral and rectal FMT at visit 2 Oral FMT at day 30
Fecal Microbial transplant Capsules: Oral capsules of FMT
Fecal Microbial Transplant Enema: FMT enema
|
|---|---|---|---|---|
|
Psychometric Hepatic Encephalopathy Score Performance Change
|
-7 score on a scale
Interval -11.0 to -3.0
|
-3 score on a scale
Interval -7.0 to -2.0
|
-5 score on a scale
Interval -9.0 to 1.0
|
-5.5 score on a scale
Interval -10.25 to 1.75
|
SECONDARY outcome
Timeframe: 60 daysCognitive assessment change using the Stroop Off and On Time change at 60 days and 6 months. This is in seconds. EncephalApp stroop is a computerized test of attention, psychomotor speed and cognitive flexibility. A higher time required to complete 5 correct runs in both Off and On stages is the measure here. There no maximum values but the lower amount of time that is needed, the better is the cognitive function.
Outcome measures
| Measure |
Placebo
n=14 Participants
Oral and rectal placebo at visit 2 Oral placebo at day 30
Placebo: Placebo
|
Group 3: Oral Placebo and Rectal FMT
n=14 Participants
Oral placebo and rectal FMT at visit 2 Oral placebo at day 30
Fecal Microbial Transplant Enema: FMT enema
Placebo: Placebo
|
Group 2: Oral FMT and Rectal Placebo
n=14 Participants
Oral FMT and rectal placebo at visit 2 Oral FMT at day 30
Fecal Microbial transplant Capsules: Oral capsules of FMT
|
Group 1: Dual Oral and Rectal FMT
n=14 Participants
Dual Oral and rectal FMT at visit 2 Oral FMT at day 30
Fecal Microbial transplant Capsules: Oral capsules of FMT
Fecal Microbial Transplant Enema: FMT enema
|
|---|---|---|---|---|
|
EncephalApp Stroop Off and On Time Change
|
218.5 units on a scale (seconds)
Interval 175.6 to 281.5
|
194.1 units on a scale (seconds)
Interval 161.9 to 265.3
|
184.8 units on a scale (seconds)
Interval 171.1 to 260.0
|
235.3 units on a scale (seconds)
Interval 177.6 to 248.0
|
SECONDARY outcome
Timeframe: 60 daysShannon diversity index compared to baseline at 30 days and then monthly till 6 months. Ranges usually from 0-10. Higher values represent a better diversity. There are no maximum values.
Outcome measures
| Measure |
Placebo
n=13 Participants
Oral and rectal placebo at visit 2 Oral placebo at day 30
Placebo: Placebo
|
Group 3: Oral Placebo and Rectal FMT
n=13 Participants
Oral placebo and rectal FMT at visit 2 Oral placebo at day 30
Fecal Microbial Transplant Enema: FMT enema
Placebo: Placebo
|
Group 2: Oral FMT and Rectal Placebo
n=12 Participants
Oral FMT and rectal placebo at visit 2 Oral FMT at day 30
Fecal Microbial transplant Capsules: Oral capsules of FMT
|
Group 1: Dual Oral and Rectal FMT
n=11 Participants
Dual Oral and rectal FMT at visit 2 Oral FMT at day 30
Fecal Microbial transplant Capsules: Oral capsules of FMT
Fecal Microbial Transplant Enema: FMT enema
|
|---|---|---|---|---|
|
Change in Microbial Diversity in Saliva
|
1.55 units on a scale
Standard Deviation 0.39
|
1.57 units on a scale
Standard Deviation 0.72
|
1.57 units on a scale
Standard Deviation 0.30
|
1.56 units on a scale
Standard Deviation 0.29
|
SECONDARY outcome
Timeframe: 6 monthsNumber of patients with Hepatic encephalopathy related events
Outcome measures
| Measure |
Placebo
n=15 Participants
Oral and rectal placebo at visit 2 Oral placebo at day 30
Placebo: Placebo
|
Group 3: Oral Placebo and Rectal FMT
n=15 Participants
Oral placebo and rectal FMT at visit 2 Oral placebo at day 30
Fecal Microbial Transplant Enema: FMT enema
Placebo: Placebo
|
Group 2: Oral FMT and Rectal Placebo
n=15 Participants
Oral FMT and rectal placebo at visit 2 Oral FMT at day 30
Fecal Microbial transplant Capsules: Oral capsules of FMT
|
Group 1: Dual Oral and Rectal FMT
n=15 Participants
Dual Oral and rectal FMT at visit 2 Oral FMT at day 30
Fecal Microbial transplant Capsules: Oral capsules of FMT
Fecal Microbial Transplant Enema: FMT enema
|
|---|---|---|---|---|
|
HE Related Events
|
6 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
Adverse Events
Placebo
Serious events: 6 serious events
Other events: 0 other events
Deaths: 1 deaths
Group 3: Oral Placebo and Rectal FMT
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2: Oral FMT and Rectal Placebo
Serious events: 5 serious events
Other events: 0 other events
Deaths: 1 deaths
Group 1: Dual Oral and Rectal FMT
Serious events: 6 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo
n=15 participants at risk
Oral and rectal placebo at visit 2 Oral placebo at day 30
Placebo: Placebo
|
Group 3: Oral Placebo and Rectal FMT
n=15 participants at risk
Oral placebo and rectal FMT at visit 2 Oral placebo at day 30
Fecal Microbial Transplant Enema: FMT enema
Placebo: Placebo
|
Group 2: Oral FMT and Rectal Placebo
n=15 participants at risk
Oral FMT and rectal placebo at visit 2 Oral FMT at day 30
Fecal Microbial transplant Capsules: Oral capsules of FMT
|
Group 1: Dual Oral and Rectal FMT
n=15 participants at risk
Dual Oral and rectal FMT at visit 2 Oral FMT at day 30
Fecal Microbial transplant Capsules: Oral capsules of FMT
Fecal Microbial Transplant Enema: FMT enema
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Liver-related hospitalizations
|
40.0%
6/15 • Number of events 9 • 6 months
|
13.3%
2/15 • Number of events 4 • 6 months
|
13.3%
2/15 • Number of events 3 • 6 months
|
13.3%
2/15 • Number of events 4 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Falls
|
6.7%
1/15 • Number of events 1 • 6 months
|
0.00%
0/15 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Nervous system disorders
Seizure recurrence
|
0.00%
0/15 • 6 months
|
6.7%
1/15 • Number of events 1 • 6 months
|
0.00%
0/15 • 6 months
|
0.00%
0/15 • 6 months
|
|
Infections and infestations
Infection
|
20.0%
3/15 • Number of events 4 • 6 months
|
13.3%
2/15 • Number of events 2 • 6 months
|
13.3%
2/15 • Number of events 2 • 6 months
|
20.0%
3/15 • Number of events 4 • 6 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place