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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

102 participants

Primary outcome timeframe

12 weeks after fecal microbiota transplantation

Results posted on

2026-06-30

Participant Flow

Participant milestones

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

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 transplantation

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).

Outcome measures

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 transplantation

total 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 transplantation

reduction 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 transplantation

Mayo 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 transplantation

Variations 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 transplantation

Duration of microbiota recovery from baseline within groups.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0、1、8、12 weeks after fecal microbiota transplantation

Intergroup 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 transplantation

Proportional 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 transplantation

Dominant bacterial strains in highly effective cases of FMT treatment.

Outcome measures

Outcome data not reported

Adverse Events

the Bai Nationality-UC

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

the Han Nationality-UC

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: +86 0871-6532-4888

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place