Fecal Microbiota Transplantation as the First-line Treatment in Active Pediatric Crohn's Disease (FMT)
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- STATUS
- Recruiting
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- End date
- Jun 30, 2025
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- participants needed
- 50
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- sponsor
- Tongji Hospital
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.
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.
Details
| Condition | Crohn Disease |
|---|---|
| Treatment | Fecal Microbiota Transplantation, PEN |
| Clinical Study Identifier | NCT05321758 |
| Sponsor | Tongji Hospital |
| Last Modified on | 28 April 2022 |
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