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Pediatric FEcal Microbial Transplant for Ulcerative Colitis (PediFETCh)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by McMaster Children's Hospital
Sponsor:
Collaborator:
Rebiotix Inc.
Information provided by (Responsible Party):
Nikhil Pai, McMaster Children's Hospital
ClinicalTrials.gov Identifier:
NCT02487238
First received: June 25, 2015
Last updated: March 21, 2017
Last verified: March 2017
  Purpose
The PediFETCh study is a pilot trial designed to assess the feasibility of fecal microbial 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.

Condition Intervention Phase
Inflammatory Bowel Disease
Ulcerative Colitis
Biological: Fecal Microbial Enema
Biological: Normal Saline Enema
Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Primary Purpose: Treatment
Official Title: A Single-Blind, Randomized, Placebo-Controlled Trial of Human Fecal Microbial Transplantation for the Therapy of Pediatric Ulcerative Colitis and Inflammatory Bowel Disease Unclassified

Resource links provided by NLM:


Further study details as provided by McMaster Children's Hospital:

Primary Outcome Measures:
  • Feasibility (Composite Measure) [ Time Frame: 30 weeks ]
    Evaluation of: participant recruitment/retention/eligibility/acceptance/adverse events


Secondary Outcome Measures:
  • Microbiome Change (Composite Measure) [ Time Frame: Weeks: 0/3/6/12/18/24/30 ]
    Change in microbial community structure/inferred metagenomic/metabolome

  • Clinical remission [ Time Frame: Weeks: 0/1/2/3/4/5/6/12/18/24/30 ]
    PUCAI score <10

  • Clinical improvement [ Time Frame: Weeks: 0/1/2/3/4/5/6/12/18/24/30 ]
    Decrease in PUCAI score

  • Biological improvement [ Time Frame: Weeks: 0/3/6/18/30 ]
    Decrease in ESR/C-reactive protein, Increase in hemoglobin/albumin

  • Mucosal healing [ Time Frame: Weeks: 0/3/6/12/18/24/30 ]
    Decrease in fecal calprotectin


Estimated Enrollment: 50
Study Start Date: November 2015
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fecal Microbial Enema
Live human donor stool prepared as fecal retention enemas. Fecal enemas are provided by Rebiotix(R) (RBX2660), using extensively screened donor stool. Enemas will be administered on site at McMaster Children's Hospital's 3E clinic by study investigators twice per week for six weeks (total = 12 enemas/6 weeks). Recipients will be blinded to enema contents.
Biological: Fecal Microbial Enema
Active intervention.
Other Names:
  • FMT
  • RBX2660
  • Rebiotix
Placebo Comparator: Normal Saline Enema
Normal saline enemas will be administered on site at McMaster Children's Hospital's 3E clinic by study investigators twice per week for six weeks (total = 12 enemas/6 weeks). Recipients will be blinded to enema contents.
Biological: Normal Saline Enema
Placebo comparator.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 6yo to 17yo at start of trial
  • Followed at McMaster Children's Hospital's Division of Pediatric Gastroenterology (may be followed concurrently at another site)
  • Ulcerative colitis (UC) or Inflammatory bowel disease unclassified (IBD-U)
  • Evidence of active clinical, biological, or mucosal disease
  • Ongoing treatment is acceptable provided no significant change in dose, or treatment modality 12 weeks prior to trial initiation

Exclusion Criteria:

  • Active participation in another therapeutic trial
  • Unable to give informed consent, or assent
  • Active Clostridium difficile infection
  • Significant change in medication dose or treatment modality within preceding 12 weeks of start of trial
  • New treatments or significant change in medication dosing during trial
  • Significant, consecutive rise in PUCAI score during trial
  • Hospitalization during trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02487238

Contacts
Contact: Nikhil Pai, MD FRCPC 9055212100 ext 75637 pain@mcmaster.ca
Contact: Jelena Popov, BSc popovj2@mcmaster.ca

Locations
Canada, Ontario
McMaster Children's Hospital Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Nikhil Pai, MD FRCPC    9055212100 ext 75637    pain@mcmaster.ca   
Contact: Jelena Popov, BSc       popovj2@mcmaster.ca   
Sponsors and Collaborators
McMaster Children's Hospital
Rebiotix Inc.
Investigators
Principal Investigator: Nikhil Pai, MD FRCPC McMaster Children's Hospital
Study Director: Jelena Popov, BSc McMaster Children's Hospital Division of Pediatric Gastroenterology & Nutrition
  More Information

Additional Information:
Publications:
Responsible Party: Nikhil Pai, Assistant Professor, McMaster Children's Hospital
ClinicalTrials.gov Identifier: NCT02487238     History of Changes
Other Study ID Numbers: 15-364
NIF-15375 ( Other Grant/Funding Number: Hamilton Health Sciences New Investigator Fund )
Study First Received: June 25, 2015
Last Updated: March 21, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by McMaster Children's Hospital:
Fecal Microbial Transplant
Microbiome
Microbiota
FMT
Pediatrics
Gastroenterology
IBD
Inflammatory Bowel Disease
Ulcerative Colitis
UC
Inflammatory Bowel Disease Unclassified
IBD-U
Rebiotix
RBX2660

Additional relevant MeSH terms:
Ulcer
Colitis, Ulcerative
Colitis
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases

ClinicalTrials.gov processed this record on March 29, 2017