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Pediatric FEcal Microbiota Transplant for Ulcerative Colitis

NCT02487238 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2019-01-30

No results posted yet for this study

Summary

The PediFETCh study is a pilot trial designed to assess the feasibility of fecal microbiota transplants for the therapy of pediatric ulcerative colitis (UC) and pediatric inflammatory bowel disease-unclassified (IBD-U). Investigators will test the hypothesis that a protocol of twice-weekly retention enemas delivered over six weeks, using fecal transplant material from a healthy donor, will improve clinical and biological disease markers in patients with pediatric UC or IBD-U.

Conditions

Interventions

BIOLOGICAL

Fecal Microbiota Enema

Active intervention.

BIOLOGICAL

Normal Saline Enema

Placebo comparator.

Sponsors & Collaborators

  • London Health Sciences Centre

    collaborator OTHER

  • St. Justine's Hospital

    collaborator OTHER

  • McMaster Children's Hospital

    lead OTHER

Principal Investigators

  • Nikhil Pai, MD FRCPC · McMaster Children's Hospital

  • Jelena Popov, BSc · McMaster Children's Hospital Division of Pediatric Gastroenterology & Nutrition

  • Tim Ramsay, PhD · The Ottawa Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Canada

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 NCT02487238 on ClinicalTrials.gov