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

Sponsor
Tongji Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05321758
Collaborator
(none)
50
1
2
39.3
1.3

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
  • Biological: Fecal Microbiota Transplantation
  • Other: PEN
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

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Partial enteral nutrition,FMTPartial enteral nutrition,FMT
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Repeated and Multiple Fecal Microbiota Transplantations Plus Partial Enteral Nutrition as the First-line Treatment in Active Pediatric Crohn's Disease
Actual Study Start Date :
Mar 22, 2022
Anticipated Primary Completion Date :
Jun 30, 2025
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

Arm Intervention/Treatment
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:
  • FMT
  • 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

    1. Clinical remission [1year]

      Clinical remission defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score≤10

    2. Endoscopic remission [1 year]

      Endoscopic remission defined by a Simple Endoscopic Score for CD (SES-CD) ≤ 2

    3. Mucosal healing [1 year]

      Mucosal healing defined as SES-CD = 0

    Secondary Outcome Measures

    1. Adverse events [During FMT and ten years after FMT]

      All possible adverse events:fever,abdominal pain,infectious diseases and others

    Other Outcome Measures

    1. 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

    Ages Eligible for Study:
    2 Years to 16 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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
    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.
    Responsible Party:
    Biao Zou, attending physician, Tongji Hospital
    ClinicalTrials.gov Identifier:
    NCT05321758
    Other Study ID Numbers:
    • 83663594
    First Posted:
    Apr 11, 2022
    Last Update Posted:
    Apr 22, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Biao Zou, attending physician, Tongji Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 22, 2022