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

NCT05321758 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-04-11

No results posted yet for this study

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.

Conditions

  • Crohn Disease

Interventions

BIOLOGICAL

Fecal Microbiota Transplantation

In the induction stage of CD, FMT was given 1-3 courses, 3-6 times per course.

DRUG

Immunosuppressive Agents

hormones, azathioprine, thalidomide

Sponsors & Collaborators

  • Tongji Hospital

    lead OTHER

Principal Investigators

  • Zhihua Huang · Tongji Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-22
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05321758 on ClinicalTrials.gov