Ulcerative Colitis (UC)Phase 2NCT07814456
Fecal Microbiota Transplantation for Ulcerative Colitis Using Dai and Han Donors
A Phase 2 study testing Fecal Microbiota Transplantation (FMT) in people with Ulcerative Colitis (UC) and Inflammatory Bowel Disease, run by First Affiliated Hospital of Kunming Medical University at 1 site in China.
Trial summary
This study is a randomized clinical trial evaluating fecal microbiota transplantation (FMT) for ulcerative colitis (UC) using healthy donors from two ethnic groups in Yunnan, China. UC is a chronic inflammatory bowel disease causing colon inflammation and ulcers. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ulcerative Colitis (UC), Inflammatory Bowel Disease
- What is being tested?
- Fecal Microbiota Transplantation (FMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 3 Feb 2026to 31 Dec 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years
- Diagnosed with ulcerative colitis (left-sided colitis) according to ECCO guidelines and Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (2023 Xi'an)
- Baseline Mayo score 3-10
- Treated only with mesalazine before and during the study to exclude drug interference
Who cannot join
- Pregnancy or planned pregnancy in the near future
- Patients in clinical remission (Mayo score ≤2 with no individual subscore >1)
- Development of diseases different from or confounding the initial diagnosis during the study
- History of toxic megacolon, perianal disease, or intestinal surgery
- Concurrent severe cardiac, pulmonary, or renal disease, or malignancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Kunming Medical University First Affiliated Hospital
Kunming, Yunnan, 650032
Zihong Chen, MD
Yinglei Miao, MD
About this study
Official title: Fecal Microbiota Transplantation for Ulcerative Colitis Using Healthy Donors From Yunnan Dai and Han Nationalities: A Randomized Study to Screen Core Metabolites and Key Microbiota
This study is a randomized clinical trial evaluating fecal microbiota transplantation (FMT) for ulcerative colitis (UC) using healthy donors from two ethnic groups in Yunnan, China. UC is a chronic inflammatory bowel disease causing colon inflammation and ulcers. FMT transfers gut bacteria from a healthy donor to a patient to restore healthy intestinal microbiota.
Previous research suggested that FMT using donors from the Dai ethnic group (a minority nationality in Yunnan with special dietary habits) may achieve better results than Han Chinese donors for UC. This study aims to confirm this finding and understand why.
Read more
The investigators will recruit 200 UC patients (ages 18-60) and randomly assign them to two groups (100 each). One group will receive FMT from healthy Han donors; the other from healthy Dai donors. Patients will receive three FMT infusions via endoscopic intestinal tubing. Treatment effects will be assessed at 12 weeks using clinical scores (Mayo score), endoscopic scores (MES), inflammatory markers (fecal calprotectin, CRP, ESR), and intestinal barrier function tests.
Stool samples will also be analyzed using metabolomics and metagenomics to identify key gut bacteria and metabolites linked to better outcomes, and laboratory experiments will be performed to verify how they reduce intestinal inflammation.
The goal is to identify optimal donor characteristics for FMT in UC and uncover mechanisms that may lead to more personalized microbiota therapies.
Read the detailed description
This randomized, parallel-group clinical study investigates the efficacy and mechanisms of fecal microbiota transplantation (FMT) using healthy donors from the Dai nationality versus Han nationality for treating ulcerative colitis (UC).
Background: UC is a chronic relapsing inflammatory bowel disease characterized by colonic mucosal inflammation. FMT has emerged as a promising therapeutic strategy by reconstructing intestinal microbiota. Preliminary findings indicate that FMT using donors from the Dai ethnic group in Yunnan Province (who have unique dietary and lifestyle habits) may achieve superior clinical remission compared to Han donors. This study aims to validate this observation and identify the core metabolites and key gut microbiota responsible for the enhanced efficacy.
Study Design: A total of 200 UC patients (aged 18-60 years, Mayo score 3-10, left-sided colitis) will be enrolled and randomly allocated into two groups (n=100 each): (1) FMT with healthy Han donors; (2) FMT with healthy Dai donors. Donors will be healthy individuals aged 18-23 years screened according to AGA guidelines.
Intervention: Patients will receive FMT via transendoscopic enteral tubing (TET) at 60 mL per infusion, once every 3 days for a total of 3 times.
Outcome Measures: Primary efficacy is clinical remission at week 12 (Mayo total score ≤2, no individual subscore >1, endoscopic subscore decreased by ≥1 from baseline). Secondary endpoints include Mayo score, MES, histopathology (HE staining), fecal calprotectin, CRP, ESR, and intestinal mucosal barrier function.
Mechanistic Investigations: Donor and recipient stool samples will be collected before FMT and at weeks 1 and 12 post-FMT. Metabolomics (LC-MS/MS, GC-MS) and metagenomic sequencing will identify differential metabolites and key bacterial taxa. Co-occurrence and metabolic complementarity networks will identify keystone species. Correlation analysis will reveal functional microbial groups. In vitro and in vivo experiments will validate the anti-inflammatory effects of identified key bacteria and metabolites.
Significance: This study will elucidate why Dai donors may confer superior FMT outcomes and identify transplantable microbial signatures and bioactive metabolites for UC therapy.
- Being tested
- Fecal Microbiota Transplantation (FMT)
- Keywords
- Fecal microbiota transplantation, Ulcerative colitis, Inflammatory bowel disease, Dai donors, Han donors, Gut microbiota, Clinical efficacy
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota Transplantation (FMT)Biological
Also called FMT; Microbiota transfer
Donor stool (60 g) is processed using the CleanFMT method with GenFMTer system, including filtration, centrifugation, washing, and resuspension in sterile normal saline (1.5× volume). The final product is 200 mL fecal suspension, administered via TET at 60 mL per session, once every 3 days, for 3 sessions total.
| Study group | Role | What they receive |
|---|---|---|
| Han Donor FMT Group | Experimental | Patients with ulcerative colitis (UC) receive fecal microbiota transplantation (FMT) from healthy Han donors aged 18-23 years. FMT is administered via transendoscopic enteral tubing (TET) at 60 mL per session, once every 3 days, for a total of 3 sessions. Only mesalazine is used before and after FMT to exclude drug interference. Clinical efficacy will be evaluated at 12 weeks post-FMT. Receives: Biological: Fecal Microbiota Transplantation (FMT) |
| Dai Donor FMT Group | Experimental | Patients with ulcerative colitis (UC) receive fecal microbiota transplantation (FMT) from healthy Dai donors aged 18-23 years from Xishuangbanna, Yunnan. FMT is administered via transendoscopic enteral tubing (TET) at 60 mL per session, once every 3 days, for a total of 3 sessions. Only mesalazine is used before and after FMT to exclude drug interference. Clinical efficacy will be evaluated at 12 weeks post-FMT. Receives: Biological: Fecal Microbiota Transplantation (FMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinical and endoscopic remission at 12 weeks
Proportion of ulcerative colitis patients achieving both clinical and endoscopic remission at 12 weeks after fecal microbiota transplantation (FMT) without corticosteroid use. Clinical remission is defined as a total Mayo score ≤2 with no individual subscore >1. Endoscopic improvement is defined as a decrease in the Mayo Endoscopic Subscore (MES) of at least 1 point from baseline. Patients must achieve both criteria simultaneously.
Measured: 12 weeks after the first FMT session
Secondary outcomes (7)
Mayo Score
Change from baseline in total Mayo score (range 0-12, higher scores indicate more severe disease activity).
Measured: Baseline (1 day pre-FMT), 1 week, and 12 weeks post-FMT
Mayo Endoscopic Subscore (MES)
Change from baseline in MES (range 0-3, where 0=normal/remission, 1=mild, 2=moderate, 3=severe).
Measured: Baseline and 12 weeks post-FMT
Histopathological Assessment by HE Staining
Histological changes in colonic mucosal biopsies assessed by HE staining.
Measured: Baseline and 12 weeks post-FMT
Fecal Calprotectin
Change from baseline in fecal calprotectin levels as a marker of intestinal inflammation.
Measured: Baseline, 1 week, and 12 weeks post-FMT
C-Reactive Protein (CRP)
Change from baseline in serum CRP levels.
Measured: Baseline, 1 week, and 12 weeks post-FMT
Erythrocyte Sedimentation Rate (ESR)
Change from baseline in ESR.
Measured: Baseline, 1 week, and 12 weeks post-FMT
Intestinal Mucosal Barrier Function
Assessment of intestinal mucosal barrier function in UC patients after FMT.
Measured: Baseline and 12 weeks post-FMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start3 Feb 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with ulcerative colitis are randomly assigned to receive fecal microbiota transplantation (FMT) from either Dai donors or Han donors in a parallel group design.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Kunming Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yinglei Miao, First Affiliated Hospital of Kunming Medical University
- Investigators
- Yinglei Miao, MD, Principal investigator, Kunming Medical University First Affiliated Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814456
- Sponsor's protocol ID
- FMT-IBD-260701
- Status last verified
- Sep 2026
- First submitted
- 30 Aug 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No