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Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis (UC)

NCT05679622 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-11-04

No results posted yet for this study

Summary

This study included two topics: one was to test the efficacy and safety of fecal microbiota transplants plus partial enteral nutrition (PEN) in refractory pediatric UC where conventional therapy has failed, and the other was to explore the efficacy and safety of FMT plus PEN as first-line therapy for pediatric active UC

Conditions

Interventions

OTHER

Fecal Microbiota Transplantation

In the induction stage of UC, FMT group received FMT and PEN intervention, and FMT group are given for at least one course of FMT treatment. If repeated FMTs are received, it is usually at a 2 month interval. All the participants received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) intervention to help induce and maintain clinical remission.

Sponsors & Collaborators

  • Biao Zou

    lead OTHER

Principal Investigators

  • Zhihua Huang · Tongji Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05679622 on ClinicalTrials.gov