Fecal Microbiota Transplantation as the First-line Treatment in Active Pediatric Crohn's Disease

Not Applicable

Recruiting

• Conditions: Crohn Disease
• Interventions: Biological: Fecal Microbiota Transplantation; Drug: Immunosuppressive Agents

• Registration Number: NCT05321758
• Lead Sponsor: Tongji Hospital

Brief 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.

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 Timeline

• Study Start: 2020-03-22
• Study First Submitted: 2022-04-04
• Study First Submitted QC: 2022-04-08
• Study First Posted: 2022-04-11
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-11
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

patients who were treated with corticosteroids, methotrexate, thiopurines, and anti-TNF agents as their first-line treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FMT group	Fecal Microbiota Transplantation	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.
Immunosuppressive group	Immunosuppressive Agents	Patients received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) combined with Immunosuppressants (hormones, azathioprine, thalidomide) treatment.

Primary Outcome Measures

Name	Time	Method
Endoscopic remission	8-12 weeks after FMT	Endoscopic remission defined by a Simple Endoscopic Score for CD （SES-CD) ≤ 2
Clinical remission	8-12 weeks after FMT	Clinical remission defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score≤10
Mucosal healing	8-12 weeks after FMT	Mucosal healing defined as SES-CD = 0

Secondary Outcome Measures

Name	Time	Method
Adverse events	2 and 10 weeks after FMT	All possible adverse events:fever,abdominal pain,infectious diseases and others

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China