Fecal Microbiota Transplantation in Pediatric Crohn's Disease

NCT ID: NCT05321745

Last Updated: 2024-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-22

Study Completion Date

2026-05-31

Brief Summary

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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

Detailed Description

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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).

Conditions

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Crohn Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Partial enteral nutrition,FMT
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Standardized FMT

Intervention Type OTHER

Fecal microbiota transplantation of fresh bacteria from healthy donor to the whole colon

Interventions

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Standardized FMT

Fecal microbiota transplantation of fresh bacteria from healthy donor to the whole colon

Intervention Type OTHER

Other Intervention Names

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Fecal Microbiota Transplantation

Eligibility Criteria

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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)
Minimum Eligible Age

2 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biao Zou

OTHER

Sponsor Role lead

Responsible Party

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Biao Zou

attending physician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sainan Shu, MD, PhD

Role: STUDY_DIRECTOR

Tongji Hospital

Locations

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Tongji Hospital

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Biao Zou, doctor

Role: CONTACT

027-83663594

Sainan Shu, MD, PhD

Role: CONTACT

027-83663594

Facility Contacts

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Biao Zou, doctor

Role: primary

15871365900

Sainan Shu, PhD

Role: backup

027-83663594

References

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Zou B, Liu S, Dong C, Shen H, Lv Y, He J, Li X, Ruan M, Huang Z, Shu S. Fecal microbiota transplantation restores gut microbiota diversity in children with active Crohn's disease: a prospective trial. J Transl Med. 2025 Mar 6;23(1):288. doi: 10.1186/s12967-024-05832-1.

Reference Type DERIVED
PMID: 40050917 (View on PubMed)

Other Identifiers

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TJ-IRB20220127

Identifier Type: OTHER

Identifier Source: secondary_id

TJ-IRB20220127

Identifier Type: -

Identifier Source: org_study_id

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