Crohn DiseaseFMTNCT05321758
Fecal Microbiota Transplantation as the First-line Treatment in Active Pediatric Crohn's Disease
A study testing Fecal Microbiota Transplantation and Immunosuppressive Agents in people with Crohn Disease, run by Tongji Hospital at 1 site in China.
Trial summary
To explore the safety and effectiveness of repeated and multiple fecal microbiota transplantations (FMTs) plus partial enteral nutrition (PEN) as a first-line treatment for active Crohn's disease (CD) in children. Read more about this study
- Who is it for?
- Ages 2 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Fecal Microbiota Transplantation and Immunosuppressive Agents
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 22 Mar 2020to 30 Jun 2027
- 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 2 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age of older than 2 years and younger than 16 years with no genetic diseases; newly diagnosed with mild-to-moderate CD ( defined by the PCDAI of >10 and ≤40, and SES-CD of >3); Subjects with no change in medication or dose at least 1 week prior to transplantation; agree to received regularly colonoscopy
Who cannot join
- patients who were treated with corticosteroids, methotrexate, thiopurines, and anti-TNF agents as their first-line treatment
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
Tongji Hospital
Wuhan, Hubei, 430030
Biao Zou, 15871365900, 464021552@qq.com
Sainan Shu, 13886011908, shusainan@163.com
About this study
Official title: Repeated and Multiple Fecal Microbiota Transplantations Plus Partial Enteral Nutrition as the First-line Treatment in Active Pediatric Crohn's Disease
To explore the safety and effectiveness of repeated and multiple fecal microbiota transplantations (FMTs) plus partial enteral nutrition (PEN) as a first-line treatment for active Crohn's disease (CD) in children.
Read the detailed description
Recent studies have suggested that gut imbalance and deregulation of immunological responses plays a pivotal role in the disease development of Crohn's disease (CD), and that FMT could be a useful treatment. Our study is aims to repeated and multiple FMTs plus PEN as a first-line treatment for active Crohn's disease (CD) in children. The patients were divided into 2 groups voluntarily. Patients treated with FMT coupled with PEN were defined as the FMT group, and those treated with PEN combined with Immunosuppressants (hormones, azathioprine, thalidomide) served as the Immunosuppressive group. The therapeutic effect of the two groups was compared. In the induction stage of CD, FMT group received FMT and PEN intervention, and FMT was given 1-3 courses, 3-6 times per course. The transplantation routes include oral capsule, enema and/or colonoscopy. All the patients received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) intervention to help induce and maintain clinical remission.
- Conditions
- Crohn Disease
- Being tested
- Fecal Microbiota Transplantation, Immunosuppressive Agents
- Keywords
- Crohn Disease;fecal microbiota transplantation
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota TransplantationBiological
Also called FMT
In the induction stage of CD, FMT was given 1-3 courses, 3-6 times per course.
Immunosuppressive AgentsDrug
Also called Immunosuppressive group
hormones, azathioprine, thalidomide
| Study group | Role | What they receive |
|---|---|---|
| FMT group | Active comparator | Repeated and multiple FMTs plus PEN(80%) in the treatment of pediatric CD. Patients received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) and FMT intervention. In the induction stage of CD, FMT was given 1-3 courses, 3-6 times per course. Receives: Biological: Fecal Microbiota Transplantation |
| Immunosuppressive group | Sham comparator | Patients received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) combined with Immunosuppressants (hormones, azathioprine, thalidomide) treatment. Receives: Drug: Immunosuppressive Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission
Clinical remission defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score≤10
Measured: 8-12 weeks after FMT
Endoscopic remission
Endoscopic remission defined by a Simple Endoscopic Score for CD （SES-CD) ≤ 2
Measured: 8-12 weeks after FMT
Mucosal healing
Mucosal healing defined as SES-CD = 0
Measured: 8-12 weeks after FMT
Secondary outcomes (1)
Adverse events
All possible adverse events:fever,abdominal pain,infectious diseases and others
Measured: 2 and 10 weeks after FMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start22 Mar 2020
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (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 Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Partial enteral nutrition,FMT
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Biao Zou, Tongji Hospital
- Investigators
- Zhihua Huang, Study director, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321758
- Sponsor's protocol ID
- 83663594
- Acronym
- FMT
- Status last verified
- Jul 2026
- First submitted
- 4 Apr 2022
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zou B, Liu S, Dong C, Shen H, Lv Y, He J, Li X, Ruan M, Huang Z, Shu S. Fecal microbiota transplantation restores gut microbiota diversity in children with active Crohn's disease: a prospective trial. J Transl Med. 2025 Mar 6;23(1):288. doi: 10.1186/s12967-024-05832-1.
PubMed 40050917
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated and Multiple Fecal Microbiota Transplantations Plus Partial Enteral Nutrition as the First-line Treatment in Active Pediatric Crohn's Disease
- ClinicalTrials.gov ID
- NCT05321758
- Acronym / sponsor ID
- FMT / 83663594
- Conditions
- Crohn Disease
- Keywords
- Crohn Disease;fecal microbiota transplantation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 22 Mar 2020 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 11 Apr 2022 (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.
To explore the safety and effectiveness of repeated and multiple fecal microbiota transplantations (FMTs) plus partial enteral nutrition (PEN) as a first-line treatment for active Crohn's disease (CD) in children.
Detailed description
Recent studies have suggested that gut imbalance and deregulation of immunological responses plays a pivotal role in the disease development of Crohn's disease (CD), and that FMT could be a useful treatment. Our study is aims to repeated and multiple FMTs plus PEN as a first-line treatment for active Crohn's disease (CD) in children. The patients were divided into 2 groups voluntarily. Patients treated with FMT coupled with PEN were defined as the FMT group, and those treated with PEN combined with Immunosuppressants (hormones, azathioprine, thalidomide) served as the Immunosuppressive group. The therapeutic effect of the two groups was compared. In the induction stage of CD, FMT group received FMT and PEN intervention, and FMT was given 1-3 courses, 3-6 times per course. The transplantation routes include oral capsule, enema and/or colonoscopy. All the patients received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) intervention to help induce and maintain clinical remission.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Partial enteral nutrition,FMT
| Arm | Type | Receives |
|---|---|---|
| FMT group | Active comparator | Biological: Fecal Microbiota TransplantationRepeated and multiple FMTs plus PEN(80%) in the treatment of pediatric CD. Patients received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) and FMT intervention. In the induction stage of CD, FMT was given 1-3 courses, 3-6 times per course. |
| Immunosuppressive group | Sham comparator | Drug: Immunosuppressive AgentsPatients received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) combined with Immunosuppressants (hormones, azathioprine, thalidomide) treatment. |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- age of older than 2 years and younger than 16 years with no genetic diseases; newly diagnosed with mild-to-moderate CD ( defined by the PCDAI of >10 and ≤40, and SES-CD of >3); Subjects with no change in medication or dose at least 1 week prior to transplantation; agree to received regularly colonoscopy
Key exclusion criteria (1 listed)
- patients who were treated with corticosteroids, methotrexate, thiopurines, and anti-TNF agents as their first-line treatment
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 TransplantationAlso: FMTIn the induction stage of CD, FMT was given 1-3 courses, 3-6 times per course. | Biological | FMT group |
| Immunosuppressive AgentsAlso: Immunosuppressive grouphormones, azathioprine, thalidomide | Drug | Immunosuppressive group |
Primary outcome
Clinical remission
Time frame: 8-12 weeks after FMT
Clinical remission defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score≤10
Endoscopic remission
Time frame: 8-12 weeks after FMT
Endoscopic remission defined by a Simple Endoscopic Score for CD （SES-CD) ≤ 2
Mucosal healing
Time frame: 8-12 weeks after FMT
Mucosal healing defined as SES-CD = 0
1 secondary outcome
Adverse events
Time frame: 2 and 10 weeks after FMT
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 10 Jul 2026.
- Derived from this study: PubMed 40050917Zou B, Liu S, Dong C, Shen H, Lv Y, He J, Li X, Ruan M, Huang Z, Shu S. Fecal microbiota transplantation restores gut microbiota diversity in children with active Crohn's disease: a prospective trial. J Transl Med. 2025 Mar 6;23(1):288. doi: 10.1186/s12967-024-05832-1.
- 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.
Zhihua Huang study director
Tongji Hospital
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 Immunosuppressive Agents in people with Crohn Disease, run by Tongji 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 10 Jul 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. Some participants in this study may receive a placebo. 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?
Contact Biao Zou, MD (15871365900, 464021552@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission (time frame: 8-12 weeks after FMT). The study lists 3 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 NCT05321758, 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 10 Jul 2026.