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The Effect of Therapeutic Fecal Transplant on the Gut Microbiome in Children With Ulcerative Colitis

NCT02291523 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2023-11-02

No results posted yet for this study

Summary

Ninety Six patients with mild to moderate ulcerative colitis will be randomized to double blind, placebo controlled study. The safety and efficacy of the intervention will be closely monitored.

Conditions

Interventions

BIOLOGICAL

Fecal Microbial Transplant

Fecal Transplant via Colonoscopy.

Sponsors & Collaborators

Principal Investigators

  • Sonia Michail, MD · Children Hospital Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-01
Primary Completion
2023-11-30
Completion
2023-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT02291523 on ClinicalTrials.gov