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CompletedNCT06591013Updated Jun 30, 2026Results posted

Efficacy and Mechanism of Fecal Microbiota Transplantation of the Bai Ethnicity in the Treatment of UC

An interventional study of Fecal microbiota transplantation in Inflammatory Bowel Diseases, sponsored by First Affiliated Hospital of Kunming Medical University. Completed at 1 site in China. Open to participants aged 14 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-06-30.

Sponsored by First Affiliated Hospital of Kunming Medical University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
14 Years to 79 Years
Sex
All
01

Study summary

Inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn's disease (CD), affects over 2 million people worldwide . Although biological therapies have significantly improved the treatment outcomes for UC, nearly two-thirds of patients experience diminishing drug responses over time, making it crucial to explore novel therapeutic approaches targeting the underlying pathophysiology of UC. UC is associated with alterations in gut microbiota, reduced microbial diversity, and changes in the relative abundance of dominant bacterial populations. Specifically, UC patients exhibit a marked decrease in gut microbiota diversity at the species level, with a reduction in Firmicutes (e.g., Clostridium butyricum) and an increase in Actinobacteria, Proteobacteria (e.g., Escherichia coli), Enterobacteriaceae, Streptococcus, and Bacteroides . Given the association between gut microbiota alterations and IBD activity, several studies have proposed microbiota-based therapies, particularly fecal microbiota transplantation (FMT), as a treatment for UC.

Read the detailed description

FMT involves the infusion of fecal material from healthy donors into patients to restore gut microbiota balance. It is currently recognized as an effective treatment for recurrent or refractory Clostridium difficile infections. Numerous studies suggest that FMT, as a therapeutic tool to regulate gut microbial homeostasis, holds potential in treating UC and other diseases, although the biochemical and/or immune mechanisms underlying its effects remain unclear . Paramsothy et al. demonstrated the efficacy of autologous FMT compared to placebo, utilizing a protocol involving colonoscopy-guided FMT followed by daily enemas for 5 days per week over 8 weeks. However, the high financial burden of this approach limits its broader clinical application. Another study revealed that donor FMT prepared anaerobically for 1-week treatment led to a higher likelihood of remission at 8 weeks compared to autologous FMT. Further research is needed to assess its safety and maintain long-term remission rates.

Our team's high-quality research findings indicate that the gut microbiota of populations in Yunnan's ethnic minority regions exhibits significantly higher diversity and regional specificity compared to urban populations. This has potential value in enhancing FMT efficacy. Previous studies revealed ethnic and regional differences in IBD prevalence in Yunnan Province, with lower rates among the Dai, Bai, and Miao ethnic groups compared to the Han population. An analysis of contributing factors highlighted the protective role of traditional ethnic diets, which increase gut microbial and viral diversity and probiotics content, thereby reducing UC prevalence. Based on this, the differences between donors in FMT may affect treatment outcomes, emphasizing the importance of identifying "high-quality" donors who maximize efficacy and minimize adverse reactions.

02

Conditions studied

  • Inflammatory Bowel Diseases

Keywords

  • fecal microbiota transplantation（FMT）
  • the Bai Nationality of Yunnan
  • Intestinal flora
  • colonoscope
  • transendoscopic enteral tubing（TET）
  • ulcerative colitis
03

In context

Inflammatory Bowel Diseases

1,460 studies on the registry are indexed under Inflammatory Bowel Diseases; 437 are open to participants now.

This study's enrollment of 102 is above the median of 70 across 770 interventional studies indexed under Inflammatory Bowel Diseases.

Browse Inflammatory Bowel Diseases studies →

Lead sponsor

First Affiliated Hospital of Kunming Medical University is the lead sponsor of 14 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
14 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age between 14 and 79 years (inclusive), any gender.
  2. Diagnosed with ulcerative colitis (UC) per established clinical, endoscopic, and histological standards, with a disease duration of over 3 months.
  3. Active mild-to-moderate UC, defined by a Mayo score of 4-10, including an endoscopic score ≥1 and a physician's global assessment score ≤2.
  4. Stable baseline medication consisting of 5-aminosalicylic acid (mesalamine).
  5. Signed written informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Participants unable to provide informed consent, answer questionnaires, or supply samples.
  2. Pregnant women or those attempting to conceive.
  3. Participants unwilling to use effective contraception throughout the study.
  4. Participants deemed in remission by investigators.
  5. Evidence or history of toxic megacolon.
  6. Isolated rectal inflammation (\<5 cm in extent).
  7. Diagnosed with Crohn's disease or indeterminate colitis.
  8. Participants with perianal diseases (e.g., fistulae, anal fissures).

  9. History of significant gastrointestinal surgery (e.g., colectomy) ：

    • Minor surgeries will be reviewed case by case.
    • Patients with appendectomy within 3 months will be excluded.
  10. Antibiotic use within the past 4 weeks for any reason, including for UC.
  11. Steroid dependence requiring >20 mg prednisone or >9 mg budesonide daily at enrollment.

  12. Recent or anticipated usage of prohibited drugs during the study period, including:

    • Rectal corticosteroids within 2 weeks prior to the first FMT.
    • Biologics (e.g., infliximab, adalimumab, vedolizumab) within 4 weeks prior to the first FMT.
    • Other major immunosuppressants (e.g., calcineurin inhibitors, antitumor drugs) within 12 weeks prior to treatment.
    • Probiotics within 4 weeks before the first FMT.
    • Experimental drugs or protocols within 12 weeks before the first FMT.
    • Anti-tuberculosis (TB or MAC) treatment within 4 weeks before the first FMT.

Permitted Medications:

Participants may continue using the following medications if doses are stable within specified timeframes before the first FMT:

  • Oral 5-aminosalicylic acid (stable for 4 weeks).
  • Azathioprine and methotrexate (≥90 days of use with stable doses for 4 weeks).
  • Oral prednisone (≤20 mg/day, stable for 2 weeks, gradually tapered at a rate of 2.5 mg/week to discontinue by week 8).

Subjects should maintain the same doses of oral 5-aminosalicylates, thiopurines, and methotrexate during the study. For oral prednisolone, the dose had to be tapered off gradually, at a rate of 2.5mg per week, so that subjects were no longer exposed to steroids until week 8.

Prohibited Medications:

  • Rectal corticosteroids (2 weeks before and throughout the study).
  • Antibiotics, antifungals, antivirals, probiotics, or prebiotics (4 weeks before and throughout the study).
  • Biologics or calcineurin inhibitors (12 weeks before and throughout the study). Participants using prohibited medications during the study will remain enrolled, and outcomes will still be evaluated. All prohibited medication usage will be recorded.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
102 participants (actual)

Study arms

  • Experimental
    the Bai nationality-UC

    Ulcerative colitis subjects will be treated with bacterial solution from the Bai nationality by colonoscope

    Procedure: Fecal microbiota transplantation

  • Experimental
    the Han nationality-UC

    Ulcerative colitis subjects will be treated with bacterial solution from the Han nationality by colonoscope

    Procedure: Fecal microbiota transplantation

Interventions

  • ProcedureFecal microbiota transplantation

    Transplantation of fresh fecal bacterial fluid into the ileocecum of patients with ulcerative colitis via the colonoscopic route

06

What researchers measure

Primary outcomes

  1. a Composite of Steroid-free Clinical Remission Together With Endoscopic Remission or Response

    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).

    Time frame: 12 weeks after fecal microbiota transplantation

Secondary outcomes

  1. Steroid-free Clinical Remission

    total Mayo score of ≤2 points with no individual sub-score \>1 point

    Time frame: 8 to 12 weeks after fecal microbiota transplantation

  2. Steroid-free Clinical Response

    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

    Time frame: 8 to 12 weeks after fecal microbiota transplantation

  3. Steroid-free Endoscopic Response

    Mayo endoscopy sub-score of 1 or less, with a reduction of at least 1 point from baseline

    Time frame: 8 to 12 weeks after fecal microbiota transplantation

  4. Changes in Microbial

    Variations in fecal microbiota composition, function, and metabolites within each group (Han donor group and Bai donor group)

    Time frame: 0、1、8、12 weeks after fecal microbiota transplantation

  5. Duration of Microbiota Recovery From Baseline Within Groups.

    Duration of microbiota recovery from baseline within groups.

    Time frame: 0、1、8、12 weeks after fecal microbiota transplantation

  6. Intergroup Differences in Recipients' Microbiota Composition Between the Han and Bai Donor Groups

    Intergroup differences in recipients' microbiota composition between the Han and Bai donor groups

    Time frame: 0、1、8、12 weeks after fecal microbiota transplantation

  7. Proportional Contributions of Recipient, Donor, or Mixed-origin Microbiota in FMT Recipients

    Proportional contributions of recipient, donor, or mixed-origin microbiota in FMT recipients

    Time frame: 0、1、8、12 weeks after fecal microbiota transplantation

  8. Dominant Bacterial Strains in Highly Effective Cases of FMT Treatment.

    Dominant bacterial strains in highly effective cases of FMT treatment.

    Time frame: 0、1、8、12 weeks after fecal microbiota transplantation

07

Results

Posted Jun 30, 2026

Participant flow

Participant flow — Overall Study
Milestonethe Bai Nationality-UCthe Han Nationality-UC
Started4148
Completed3031
Not completed1117

Outcome measures

Primarya Composite of Steroid-free Clinical Remission Together With Endoscopic Remission or Response

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).

Time frame:
12 weeks after fecal microbiota transplantation
Reported as:
Count of participants · Participants
a Composite of Steroid-free Clinical Remission Together With Endoscopic Remission or Response
Participantsthe Bai Nationality-UCthe Han Nationality-UC
a Composite of Steroid-free Clinical Remission Together With Endoscopic Remission or Response2416
SecondarySteroid-free Clinical Remission

total Mayo score of ≤2 points with no individual sub-score \>1 point

Time frame:
8 to 12 weeks after fecal microbiota transplantation

Results for this outcome have not been posted.

SecondarySteroid-free Clinical Response

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

Time frame:
8 to 12 weeks after fecal microbiota transplantation

Results for this outcome have not been posted.

SecondarySteroid-free Endoscopic Response

Mayo endoscopy sub-score of 1 or less, with a reduction of at least 1 point from baseline

Time frame:
8 to 12 weeks after fecal microbiota transplantation

Results for this outcome have not been posted.

SecondaryChanges in Microbial

Variations in fecal microbiota composition, function, and metabolites within each group (Han donor group and Bai donor group)

Time frame:
0、1、8、12 weeks after fecal microbiota transplantation

Results for this outcome have not been posted.

SecondaryDuration of Microbiota Recovery From Baseline Within Groups.

Duration of microbiota recovery from baseline within groups.

Time frame:
0、1、8、12 weeks after fecal microbiota transplantation

Results for this outcome have not been posted.

SecondaryIntergroup Differences in Recipients' Microbiota Composition Between the Han and Bai Donor Groups

Intergroup differences in recipients' microbiota composition between the Han and Bai donor groups

Time frame:
0、1、8、12 weeks after fecal microbiota transplantation

Results for this outcome have not been posted.

SecondaryProportional Contributions of Recipient, Donor, or Mixed-origin Microbiota in FMT Recipients

Proportional contributions of recipient, donor, or mixed-origin microbiota in FMT recipients

Time frame:
0、1、8、12 weeks after fecal microbiota transplantation

Results for this outcome have not been posted.

SecondaryDominant Bacterial Strains in Highly Effective Cases of FMT Treatment.

Dominant bacterial strains in highly effective cases of FMT treatment.

Time frame:
0、1、8、12 weeks after fecal microbiota transplantation

Results for this outcome have not been posted.

Adverse events

Collected over The collection of AEs, including serious adverse events (SAEs), will begin from the first administration of FMT. Routine AE collection will continue until week 1.Since participants will transition to standard care after week 1, AEs occurring beyond this period will not be collected.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
the Bai Nationality-UC0/41 (0%)0/41 (0%)0/41 (0%)
the Han Nationality-UC0/48 (0%)0/48 (0%)0/48 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)the Bai Nationality-UCthe Han Nationality-UCTotal
Mean45 (15 to 73)44.73 (21 to 76)44.85 (15 to 76)
Sex: Female, Male
Sex: Female, Male(Participants)the Bai Nationality-UCthe Han Nationality-UCTotal
Female132033
Male282856
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)the Bai Nationality-UCthe Han Nationality-UCTotal
Count of participants——0
08

Study locations

1 site
  • China
    Kunming, Yunnan 650032, China
09

References and documents

Study documents

  • Protocol, analysis plan and consent form · Apr 22, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06591013
Lead sponsor
First Affiliated Hospital of Kunming Medical University
Collaborators
Chinese University of Hong Kong
Responsible party
Yinglei Miao (Director, First Affiliated Hospital of Kunming Medical University) — Principal investigator
First posted
Sep 19, 2024
Start date
Oct 14, 2024
Primary completion
Oct 20, 2025
Completion
Oct 31, 2025
Results posted
Jun 30, 2026
Last update
Jun 30, 2026

Study contacts

L Y Miao, Doctor
principal investigator · First Affiliated Hospital of Kunming Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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