Inflammatory Bowel Disease (Crohn&Amp;#39;s Disease and Ulcerative Colitis)NCT07149441
Efficacy and Mechanism of FMT in the Treatment of Inflammatory Bowel Disease: an Open-label Randomized Controlled Study
A study testing Fecal microbiota transplantation and infliximab in people with Inflammatory Bowel Disease (Crohn&Amp;#39;s Disease and Ulcerative Colitis) and Fecal Microbiota Transplantation, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
This study enrolled 94 patients with UC or CD. Two groups received either 8-week intestinal bacterial transplant capsule therapy or biological therapy, respectively. The control group received biological therapy alone, while the experimental group received biological therapy combined with FMT. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inflammatory Bowel Disease (Crohn&Amp;#39;s Disease and Ulcerative Colitis), Fecal Microbiota Transplantation
- What is being tested?
- Fecal microbiota transplantation and infliximab
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The diagnosis was UC or CD, and the diagnosis was based on clinical, endoscopic and pathological evidence.
- IBD should be diagnosed for at least 6 months to rule out the possibility of natural remission of new cases.
- Patients should be in mild to moderate active stage (UC: Mayo score 3-10; CD: CDAI score: 150-449)
- Biological agents (such as anti-TNF-α drugs, vedolizumab, etc.) were used in the past, but no clinical remission was achieved.
- Voluntary participation and signing of informed consent.
- Adults aged 18-65.
- Can tolerate oral enterobacteria transplantation capsule treatment.
Who cannot join
- The diagnosis was UC or CD, and the diagnosis was based on clinical, endoscopic and pathological evidence.
- IBD should be diagnosed for at least 6 months to rule out the possibility of natural remission of new cases.
- Patients should be in mild to moderate active stage (UC: Mayo score 3-10; CD: CDAI score: 150-449)
- Biological agents (such as anti-TNF-α drugs, vedolizumab, etc.) were used in the past, but no clinical remission was achieved.
- Voluntary participation and signing of informed consent.
- Adults aged 18-65.
- Can tolerate oral enterobacteria transplantation capsule treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Mechanism of Fecal Microbiota Transplantation in the Treatment of Inflammatory Bowel Disease: an Open-label Randomized Controlled Study
This study enrolled 94 patients with UC or CD. Two groups received either 8-week intestinal bacterial transplant capsule therapy or biological therapy, respectively. The control group received biological therapy alone, while the experimental group received biological therapy combined with FMT. Both groups were followed up for 52 weeks after discharge. The efficacy of FMT capsule therapy on the subjects' UC or CD symptom-related scores and its effect on remodeling the intestinal flora were observed, and its safety was verified.
- Conditions
- Inflammatory Bowel Disease (Crohn&Amp;#39;s Disease and Ulcerative Colitis), Fecal Microbiota Transplantation
- Being tested
- Fecal microbiota transplantation, infliximab
- 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
Fecal microbiota transplantation (FMT) achieves the purpose of treating intestinal and extra-intestinal diseases by transplanting the functional microbes in the feces of healthy people into the patient's intestine through the upper or lower alimentary tract routes to rebuild the patient's intestinal microbiota.
infliximabDrug
Also called Biological agent
Intravenous infusion of infliximab once every 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Biological agent +FMT | Experimental | 47 patients were treated with biological agents combined with fecal microbiota transplants (FMT). All patients were followed up for 52 weeks after discharge. To observe the curative effect of FMT capsule treatment on UC or CD symptom-related scores of subjects and its remodeling effect on intestinal flora and verify its safety. Receives: Procedure: Fecal microbiota transplantation; Drug: infliximab |
| Biological agent | Experimental | 47 patients were treated with biological agents. All patients were followed up for 52 weeks after discharge. To observe the curative effect of FMT capsule treatment on UC or CD symptom-related scores of subjects and its remodeling effect on intestinal flora and verify its safety. Receives: Drug: infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic remission rate
UC is endoscopic Mayo score 0-1; CD is simple endoscopic score (SES-CD)<3 or no ulcer.
Measured: 14th and 52nd week after joining the group.
Clinical remission rate
UC is defined as Mayo score ≤2, and no single score > 1; CD is defined as CDAI (Crohn's disease activity index) < 150.
Measured: 14th and 52nd week after joining the group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start1 Aug 2025
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel Disease (Crohn&Amp;#39;s Disease and Ulcerative Colitis)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen QiYi, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149441
- Sponsor's protocol ID
- FMT-IBD
- Status last verified
- Aug 2025
- First submitted
- 24 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang X, Wu W, Yang B, Liu Y, Xu Y, Wang L, Lv X, Gao J, Lu M, Yu A, Li N, Chen Q, Lu L, Zhao D. Additive effects of fecal microbiota transplantation and infliximab on gut microbiome and metabolome in refractory inflammatory bowel disease patients. mSystems. 2026 Apr 21;11(4):e0077425. doi: 10.1128/msystems.00774-25. Epub 2026 Mar 23.
PubMed 41870087
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Mechanism of Fecal Microbiota Transplantation in the Treatment of Inflammatory Bowel Disease: an Open-label Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07149441
- Acronym / sponsor ID
- FMT-IBD
- Conditions
- Inflammatory Bowel Disease (Crohn&Amp;#39;s Disease and Ulcerative Colitis), Fecal Microbiota Transplantation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 2 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study enrolled 94 patients with UC or CD. Two groups received either 8-week intestinal bacterial transplant capsule therapy or biological therapy, respectively. The control group received biological therapy alone, while the experimental group received biological therapy combined with FMT. Both groups were followed up for 52 weeks after discharge. The efficacy of FMT capsule therapy on the subjects' UC or CD symptom-related scores and its effect on remodeling the intestinal flora were observed, and its safety was verified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biological agent +FMT | Experimental | Procedure: Fecal microbiota transplantation, Drug: infliximab47 patients were treated with biological agents combined with fecal microbiota transplants (FMT). All patients were followed up for 52 weeks after discharge. To observe the curative effect of FMT capsule treatment on UC or CD symptom-related scores of subjects and its remodeling effect on intestinal flora and verify its safety. |
| Biological agent | Experimental | Drug: infliximab47 patients were treated with biological agents. All patients were followed up for 52 weeks after discharge. To observe the curative effect of FMT capsule treatment on UC or CD symptom-related scores of subjects and its remodeling effect on intestinal flora and verify its safety. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The diagnosis was UC or CD, and the diagnosis was based on clinical, endoscopic and pathological evidence.
- IBD should be diagnosed for at least 6 months to rule out the possibility of natural remission of new cases.
- Patients should be in mild to moderate active stage (UC: Mayo score 3-10; CD: CDAI score: 150-449)
- Biological agents (such as anti-TNF-α drugs, vedolizumab, etc.) were used in the past, but no clinical remission was achieved.
- Voluntary participation and signing of informed consent.
Key exclusion criteria (7 listed)
- The diagnosis was UC or CD, and the diagnosis was based on clinical, endoscopic and pathological evidence.
- IBD should be diagnosed for at least 6 months to rule out the possibility of natural remission of new cases.
- Patients should be in mild to moderate active stage (UC: Mayo score 3-10; CD: CDAI score: 150-449)
- Biological agents (such as anti-TNF-α drugs, vedolizumab, etc.) were used in the past, but no clinical remission was achieved.
- Voluntary participation and signing of informed consent.
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 transplantationFecal microbiota transplantation (FMT) achieves the purpose of treating intestinal and extra-intestinal diseases by transplanting the functional microbes in the feces of healthy people into the patient's intestine through the upper or lower alimentary tract routes to rebuild the patient's intestinal microbiota. | Procedure or surgery | Biological agent +FMT |
| infliximabAlso: Biological agentIntravenous infusion of infliximab once every 8 weeks. | Drug | Biological agent, Biological agent +FMT |
Primary outcome
Endoscopic remission rate
Time frame: 14th and 52nd week after joining the group.
UC is endoscopic Mayo score 0-1; CD is simple endoscopic score (SES-CD)<3 or no ulcer.
Clinical remission rate
Time frame: 14th and 52nd week after joining the group.
UC is defined as Mayo score ≤2, and no single score > 1; CD is defined as CDAI (Crohn's disease activity index) < 150.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Derived from this study: PubMed 41870087Wang X, Wu W, Yang B, Liu Y, Xu Y, Wang L, Lv X, Gao J, Lu M, Yu A, Li N, Chen Q, Lu L, Zhao D. Additive effects of fecal microbiota transplantation and infliximab on gut microbiome and metabolome in refractory inflammatory bowel disease patients. mSystems. 2026 Apr 21;11(4):e0077425. doi: 10.1128/msystems.00774-25. Epub 2026 Mar 23.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and infliximab in people with Inflammatory Bowel Disease (Crohn&Amp;#39;s Disease and Ulcerative Colitis) and Fecal Microbiota Transplantation, run by Shanghai 10th People's Hospital 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 7 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Endoscopic remission rate (time frame: 14th and 52nd week after joining the group.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07149441, which also lists 1 linked publication.
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 2 Sep 2025.