Trial Outcomes & Findings for Efficacy and Mechanism of Fecal Microbiota Transplantation of the Bai Ethnicity in the Treatment of UC (NCT NCT06591013)
NCT ID: NCT06591013
Last Updated: 2026-06-30
Results Overview
total Mayo score of ≤2 points with no individual sub-score \>1 point, and at least a 1 point reduction from baseline in the endoscopy sub-score (MES).
COMPLETED
NA
102 participants
12 weeks after fecal microbiota transplantation
2026-06-30
Participant Flow
Participant milestones
| Measure |
the Bai Nationality-UC
Ulcerative colitis subjects will be treated with bacterial solution from the Bai nationality by colonoscope
|
the Han Nationality-UC
Ulcerative colitis subjects will be treated with bacterial solution from the Han nationality by colonoscope
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
48
|
|
Overall Study
COMPLETED
|
30
|
31
|
|
Overall Study
NOT COMPLETED
|
11
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
the Bai Nationality-UC
n=41 Participants
Ulcerative colitis subjects will be treated with bacterial solution from the Bai nationality by colonoscope
|
the Han Nationality-UC
n=48 Participants
Ulcerative colitis subjects will be treated with bacterial solution from the Han nationality by colonoscope
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45 years
n=41 Participants
|
44.73 years
n=48 Participants
|
44.85 years
n=89 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=41 Participants
|
20 Participants
n=48 Participants
|
33 Participants
n=89 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=41 Participants
|
28 Participants
n=48 Participants
|
56 Participants
n=89 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 12 weeks after fecal microbiota transplantationtotal Mayo score of ≤2 points with no individual sub-score \>1 point, and at least a 1 point reduction from baseline in the endoscopy sub-score (MES).
Outcome measures
| Measure |
the Bai Nationality-UC
n=30 Participants
Ulcerative colitis subjects will be treated with bacterial solution from the Bai nationality by colonoscope
|
the Han Nationality-UC
n=31 Participants
Ulcerative colitis subjects will be treated with bacterial solution from the Han nationality by colonoscope
|
|---|---|---|
|
a Composite of Steroid-free Clinical Remission Together With Endoscopic Remission or Response
|
24 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 8 to 12 weeks after fecal microbiota transplantationtotal Mayo score of ≤2 points with no individual sub-score \>1 point
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 to 12 weeks after fecal microbiota transplantationreduction of 3 points or more on the Mayo score, a 50% or greater reduction from baseline in combined rectal bleeding plus stool frequency Mayo sub-scores, or both
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 to 12 weeks after fecal microbiota transplantationMayo endoscopy sub-score of 1 or less, with a reduction of at least 1 point from baseline
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0、1、8、12 weeks after fecal microbiota transplantationVariations in fecal microbiota composition, function, and metabolites within each group (Han donor group and Bai donor group)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0、1、8、12 weeks after fecal microbiota transplantationDuration of microbiota recovery from baseline within groups.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0、1、8、12 weeks after fecal microbiota transplantationIntergroup differences in recipients' microbiota composition between the Han and Bai donor groups
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0、1、8、12 weeks after fecal microbiota transplantationProportional contributions of recipient, donor, or mixed-origin microbiota in FMT recipients
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0、1、8、12 weeks after fecal microbiota transplantationDominant bacterial strains in highly effective cases of FMT treatment.
Outcome measures
Outcome data not reported
Adverse Events
the Bai Nationality-UC
the Han Nationality-UC
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr.Yinglei Miao, Director of Clinical Trials
The First Affiliated Hospital of Kunming Medical University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place