Fecal Microbiota Transplantation in Pediatric Crohn's Disease (FMT)

November 1, 2024 updated by: Biao Zou

Repeated and Periodic Fecal Microbiota Transplantation in Children With Active and Refractory Crohn's Disease

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 1-2 courses, 3-6 times per course. In the maintaining stage, FMT was performed every 3 months, with the same 3-6 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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 12 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Aged 2-16 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 3 months; known contraindication to all FMT infusion method such as nasoduodenal tube insertion, oesophago-gastro-duodenoscopy (OGD), enteroscopy, colonoscopy, enema and Fecal capsule; unwilling to give informed consent/assent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Fecal Microbiota Transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical remission
Time Frame: 8-12 weeks after FMT
Clinical remission defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score≤10
8-12 weeks after FMT
Endoscopic remission
Time Frame: 8-12 weeks after FMT
Endoscopic remission defined by a Simple Endoscopic Score for CD （SES-CD) ≤ 2
8-12 weeks after FMT
Mucosal healing
Time Frame: 8-12 weeks after FMT
Mucosal healing defined as SES-CD = 0
8-12 weeks after FMT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 2 and 8 weeks after FMT
All possible adverse events:fever,abdominal pain,infectious diseases and others
2 and 8 weeks after FMT

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
gut microbial
Time Frame: before treatment and 4-8 weeks after treatment
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.
before treatment and 4-8 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biao Zou

Investigators

  • Study Director: Sainan Shu, MD, PhD, Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2022

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

April 4, 2022

First Submitted That Met QC Criteria

April 4, 2022

First Posted (Actual)

April 11, 2022

Study Record Updates

Last Update Posted (Estimated)

November 4, 2024

Last Update Submitted That Met QC Criteria

November 1, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJ-IRB20220127 (Other Identifier: Tongji Hospital)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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