FMT: Fecal Microbiota Transplantation in Pediatric Crohn's Disease
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 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 3 courses, 3 times per course. In the maintaining stage, FMT was performed every 3 months, with the same 3 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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Repeated and multiple FMTs plus PEN repeated and multiple FMTs plus PEN(50% of total calories as polymeric diet, Peptamen, Nestle, Vevey, Switzerland) in refractory pediatric CD |
Other: Standardized FMT
Fecal microbiota transplantation of fresh bacteria from healthy donor to the whole colon
Other Names:
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Outcome Measures
Primary Outcome Measures
- Clinical remission [1 year]
Clinical remission defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score≤10
- Endoscopic remission [1 year]
Endoscopic remission defined by a Simple Endoscopic Score for CD （SES-CD) ≤ 2
- Mucosal healing [1 year]
Mucosal healing defined as SES-CD = 0
Secondary Outcome Measures
- Adverse events [During FMT and ten years after FMT]
All possible adverse events:fever,abdominal pain,infectious diseases and others
Other Outcome Measures
- gut microbial [24 weeks]
Fecal 16S RNA or macrogene sequencing was performed. Fecal samples were obtained from donor and recipient. The fecal samples and isolated microbiota samples were frozen immediately and underwent DNA extraction using standard methods.
Eligibility Criteria
Criteria
Inclusion Criteria:
Aged 6-14 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 1 year; Known contraindication to all FMT infusion method such as nasoduodenal tube insertion, oesophago-gastro-duodenoscopy (OGD), enteroscopy, colonoscopy and enema; Unwilling to give informed consent/assent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tongji Hospital | Wuhan | Hubei | China | 430030 |
Sponsors and Collaborators
- Biao Zou
Investigators
- Study Director: Sainan Shu, MD, PhD, Tongji Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TJ-IRB20220127
- TJ-IRB20220127