Inflammatory Bowel DiseasesNCT06591013
Efficacy and Mechanism of Fecal Microbiota Transplantation of the Bai Ethnicity in the Treatment of UC
A study testing Fecal microbiota transplantation in people with Inflammatory Bowel Diseases, run by First Affiliated Hospital of Kunming Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 79 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Fecal microbiota transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 14 Oct 2024to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 79 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age between 14 and 79 years (inclusive), any gender.
- Diagnosed with ulcerative colitis (UC) per established clinical, endoscopic, and histological standards, with a disease duration of over 3 months.
- 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.
- Stable baseline medication consisting of 5-aminosalicylic acid (mesalamine).
- Signed written informed consent.
Who cannot join
- Participants unable to provide informed consent, answer questionnaires, or supply samples.
- Pregnant women or those attempting to conceive.
- Participants unwilling to use effective contraception throughout the study.
- Participants deemed in remission by investigators.
- Evidence or history of toxic megacolon.
- Isolated rectal inflammation (<5 cm in extent).
Show all 30Show fewer
- Diagnosed with Crohn's disease or indeterminate colitis.
- Participants with perianal diseases (e.g., fistulae, anal fissures).
- 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.
- Antibiotic use within the past 4 weeks for any reason, including for UC.
- Steroid dependence requiring >20 mg prednisone or >9 mg budesonide daily at enrollment.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Research on the Mechanisms of Different Donors in Fecal Microbiota Transplantation for Treating Ulcerative Colitis
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.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Fecal microbiota transplantation
- Keywords
- fecal microbiota transplantation（FMT）, the Bai Nationality of Yunnan, Intestinal flora, colonoscope, transendoscopic enteral tubing（TET）, ulcerative colitis
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantationProcedure or surgery
Transplantation of fresh fecal bacterial fluid into the ileocecum of patients with ulcerative colitis via the colonoscopic route
| Study group | Role | What they receive |
|---|---|---|
| the Bai nationality-UC | Experimental | Ulcerative colitis subjects will be treated with bacterial solution from the Bai nationality by colonoscope Receives: Procedure: Fecal microbiota transplantation |
| the Han nationality-UC | Experimental | Ulcerative colitis subjects will be treated with bacterial solution from the Han nationality by colonoscope Receives: Procedure: Fecal microbiota transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks after fecal microbiota transplantation
Secondary outcomes (8)
Steroid-free Clinical Remission
total Mayo score of ≤2 points with no individual sub-score >1 point
Measured: 8 to 12 weeks after fecal microbiota transplantation
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
Measured: 8 to 12 weeks after fecal microbiota transplantation
Steroid-free Endoscopic Response
Mayo endoscopy sub-score of 1 or less, with a reduction of at least 1 point from baseline
Measured: 8 to 12 weeks after fecal microbiota transplantation
Changes in Microbial
Variations in fecal microbiota composition, function, and metabolites within each group (Han donor group and Bai donor group)
Measured: 0、1、8、12 weeks after fecal microbiota transplantation
Duration of Microbiota Recovery From Baseline Within Groups.
Duration of microbiota recovery from baseline within groups.
Measured: 0、1、8、12 weeks after fecal microbiota transplantation
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
Measured: 0、1、8、12 weeks after fecal microbiota transplantation
Proportional Contributions of Recipient, Donor, or Mixed-origin Microbiota in FMT Recipients
Proportional contributions of recipient, donor, or mixed-origin microbiota in FMT recipients
Measured: 0、1、8、12 weeks after fecal microbiota transplantation
Dominant Bacterial Strains in Highly Effective Cases of FMT Treatment.
Dominant bacterial strains in highly effective cases of FMT treatment.
Measured: 0、1、8、12 weeks after fecal microbiota transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start14 Oct 2024
- Primary completion20 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Inflammatory Bowel DiseasesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Kunming Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Responsible party
- Principal investigator, Yinglei Miao, First Affiliated Hospital of Kunming Medical University
- Investigators
- L Y Miao, Doctor, Principal investigator, First Affiliated Hospital of Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591013
- Sponsor's protocol ID
- FMT-IBD-240710
- Status last verified
- Jun 2026
- First submitted
- 17 Jul 2024
- Last updated
- 30 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Mechanisms of Different Donors in Fecal Microbiota Transplantation for Treating Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT06591013
- Acronym / sponsor ID
- FMT-IBD-240710
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- fecal microbiota transplantation（FMT）, the Bai Nationality of Yunnan, Intestinal flora, colonoscope, transendoscopic enteral tubing（TET）, ulcerative colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Kunming Medical UniversityUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Posted 30 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the Bai nationality-UC | Experimental | Procedure: Fecal microbiota transplantationUlcerative colitis subjects will be treated with bacterial solution from the Bai nationality by colonoscope |
| the Han nationality-UC | Experimental | Procedure: Fecal microbiota transplantationUlcerative colitis subjects will be treated with bacterial solution from the Han nationality by colonoscope |
Who may qualify
- Ages
- 14 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 14 and 79 years (inclusive), any gender.
- Diagnosed with ulcerative colitis (UC) per established clinical, endoscopic, and histological standards, with a disease duration of over 3 months.
- 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.
- Stable baseline medication consisting of 5-aminosalicylic acid (mesalamine).
- Signed written informed consent.
Key exclusion criteria (30 listed)
- Participants unable to provide informed consent, answer questionnaires, or supply samples.
- Pregnant women or those attempting to conceive.
- Participants unwilling to use effective contraception throughout the study.
- Participants deemed in remission by investigators.
- Evidence or history of toxic megacolon.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal microbiota transplantationTransplantation of fresh fecal bacterial fluid into the ileocecum of patients with ulcerative colitis via the colonoscopic route | Procedure or surgery | the Bai nationality-UC, the Han nationality-UC |
Primary outcome
a Composite of Steroid-free Clinical Remission Together With Endoscopic Remission or Response
Time frame: 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).
8 secondary outcomes
Steroid-free Clinical Remission
Time frame: 8 to 12 weeks after fecal microbiota transplantation
Steroid-free Clinical Response
Time frame: 8 to 12 weeks after fecal microbiota transplantation
Steroid-free Endoscopic Response
Time frame: 8 to 12 weeks after fecal microbiota transplantation
Changes in Microbial
Time frame: 0、1、8、12 weeks after fecal microbiota transplantation
Duration of Microbiota Recovery From Baseline Within Groups.
Time frame: 0、1、8、12 weeks after fecal microbiota transplantation
Intergroup Differences in Recipients' Microbiota Composition Between the Han and Bai Donor Groups
Time frame: 0、1、8、12 weeks after fecal microbiota transplantation
Proportional Contributions of Recipient, Donor, or Mixed-origin Microbiota in FMT Recipients
Time frame: 0、1、8、12 weeks after fecal microbiota transplantation
Dominant Bacterial Strains in Highly Effective Cases of FMT Treatment.
Time frame: 0、1、8、12 weeks after fecal microbiota transplantation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
L Y Miao, Doctor principal investigator
First Affiliated Hospital of Kunming Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal microbiota transplantation in people with Inflammatory Bowel Diseases, run by First Affiliated Hospital of Kunming Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a Composite of Steroid-free Clinical Remission Together With Endoscopic Remission or Response (time frame: 12 weeks after fecal microbiota transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.