FMT: Fecal Microbiota Transplantation as the First-line Treatment in Active Pediatric Crohn's Disease
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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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 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 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. 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
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: FMT group 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 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. |
Biological: Fecal Microbiota Transplantation
In the induction stage of CD, 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
Other Names:
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Sham Comparator: PEN group Patients received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) intervention |
Other: PEN
PEN
|
Outcome Measures
Primary Outcome Measures
- Clinical remission [1year]
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:
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Tongji Hospital | Wuhan | Hubei | China | 430030 |
Sponsors and Collaborators
- Tongji Hospital
Investigators
- Study Director: Zhihua Huang, Tongji Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 83663594