Fecal Microbiota Transplantation in Pediatric Crohn's Disease

Study Overview
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Brief Summary
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This study will test the safety and effectiveness of fecal microbiota transplantation (FMT) plus partial enteral nutrition (PEN) in refractory pediatric Crohn's disease (CD) who have failed conventional treatment

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 in the treatment of refractory pediatric CD. In the induction stage of CD, standard therapy remained unchanged, FMT and PEN were added, and FMT was given 1-2 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, and the withdrawal of conventional drug therapy was gradually reduced. Refractory CD was defined as refractory to standard therapy (e.g., steroids, immunomodulators, cyclosporine, tacrolimus, or anti-TNF agents).

Official Title
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Repeated and Periodic Fecal Microbiota Transplantation in Children With Active and Refractory Crohn's Disease

Conditions
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Crohn Disease

Intervention / Treatment
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* Other: Standardized FMT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 2-16 years and without genetic diseases; All refractory pediatric with mild-to-moderate CD; Mild-to-moderate CD, defined by the pediatric Crohn's disease activity index (PCDAI) >10 and ≤40 and Simple Endoscopic Score for CD (SES-CD) > 3 were enrolled in the study; refractory CD, defined by children who failed conventional treatment (hormone, immunosuppressant, biologics) Exclusion Criteria Children who were treated by PEN (80%) less than 8 weeks; follow up less than 3 months; known contraindication to all FMT infusion method such as nasoduodenal tube insertion, oesophago-gastro-duodenoscopy (OGD), enteroscopy, colonoscopy, enema and Fecal capsule; unwilling to give informed consent/assent

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Partial enteral nutrition,FMT
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Repeated and multiple FMTs plus PEN<br>repeated and multiple FMTs plus PEN(50% of total calories as polymeric diet, Peptamen, Nestle, Vevey, Switzerland) in refractory pediatric CD | Other: Standardized FMT<br>* Fecal microbiota transplantation of fresh bacteria from healthy donor to the whole colon<br>* Other names: Fecal Microbiota Transplantation;|

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 8 weeks after FMT | 

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