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

  • End date
    Jun 30, 2025
  • participants needed
  • sponsor
    Tongji Hospital
Updated on 28 April 2022
crohn's disease
fecal microbiota transplantation
enteral nutrition
pediatric onset crohn's disease
Accepts healthy volunteers


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.


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.

Condition Crohn Disease
Treatment Fecal Microbiota Transplantation, PEN
Clinical Study IdentifierNCT05321758
SponsorTongji Hospital
Last Modified on28 April 2022


Yes No Not Sure

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
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