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

Study Overview
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Brief Summary
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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
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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. Patients treated with FMT coupled with PEN were defined as the FMT group, and those treated with PEN alone served as the PEN group. 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. In the maintaining stage, FMT was performed every 3 months, with the same 3-6 times of FMT treatment for each course. 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.

Official Title
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Repeated and Multiple Fecal Microbiota Transplantations Plus Partial Enteral Nutrition as the First-line Treatment in Active Pediatric Crohn's Disease

Conditions
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Crohn Disease

Intervention / Treatment
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* Biological: Fecal Microbiota Transplantation
* Other: PEN


Participation Criteria
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Eligibility Criteria
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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); agree to received regularly colonoscopy Exclusion Criteria: patients who were treated with corticosteroids, methotrexate, thiopurines, and anti-TNF agents as their first-line treatment

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Partial enteral nutrition,FMT
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FMT group<br>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. In the maintaining stage, FMT was performed every 3 months, with the same 3-6 times of FMT treatment for each course. | Biological: Fecal Microbiota Transplantation<br>* In the induction stage of CD, FMT was given 1-3 courses, 3-6 times per course. In the maintaining stage, FMT was performed every 3 months, with the same 3-6 times of FMT treatment for each course<br>* Other names: FMT;|
| Sham Comparator: PEN group<br>Patients received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) intervention | Other: PEN<br>* PEN<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | All possible adverse events:fever,abdominal pain,infectious diseases and others | 2 and 8weeks weeks after FMT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn Disease;fecal microbiota transplantation