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Pediatric FEcal Microbial Transplant for Ulcerative Colitis (PediFETCh)

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ClinicalTrials.gov Identifier: NCT02487238
Recruitment Status : Recruiting
First Posted : July 1, 2015
Last Update Posted : December 19, 2017
Sponsor:
Collaborators:
London Health Sciences Centre
St. Justine's Hospital
Information provided by (Responsible Party):
Nikhil Pai, McMaster Children's Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Inflammatory Bowel Disease Ulcerative Colitis Biological: Fecal Microbial Enema Biological: Normal Saline Enema Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : November 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018


Arm Intervention/treatment
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.




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


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

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

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

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

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



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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 3yo to 17yo at start of trial
  • Followed at a) McMaster Children's Hospital, or b) London Health Sciences Centre 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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   
Children's Hospital London Health Science Centre Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Katherine Barnes, BSc    5196858500 ext 56074    Katherine.Barnes@lhsc.on.ca   
Principal Investigator: Dhandapani Ashok, MD FRCPCH         
Canada, Quebec
CHU Sainte-Justine Recruiting
Montreal, Quebec, Canada, H3T 1C5
Contact: Julie Briere    514-345-4931 ext 6666    julie.briere@recherche-ste-justine.qc.ca   
Contact: Kelly Grzywacz    514-345-4931 ext 6666    grzkell@hotmail.com   
Principal Investigator: Kelly Grzywacz, BSc, MD         
Sponsors and Collaborators
McMaster Children's Hospital
London Health Sciences Centre
St. Justine's Hospital
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

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 )
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Nikhil Pai, 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:
Colitis
Ulcer
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes