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Pediatric FEcal Microbiota Transplant for Ulcerative Colitis (PediFETCh)

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ClinicalTrials.gov Identifier: NCT02487238
Recruitment Status : Completed
First Posted : July 1, 2015
Last Update Posted : January 30, 2019
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 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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease Ulcerative Colitis Biological: Fecal Microbiota Enema Biological: Normal Saline Enema Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized to receive either the fecal microbial enema containing healthy donor stool OR the normal saline enema placebo. Patients who receive the normal saline enema placebo may be eligible to still receive the fecal microbial enema when they finish the trial.
Masking: Single (Participant)
Masking Description: Patients will not be aware of which type of enema they have been randomized to receive (fecal microbial enema, or normal saline enema). Patients who were randomized to the normal saline enema will still be eligible to receive the fecal microbial enema when they finish the trial; these patients will know what they are receiving and no longer need masking.
Primary Purpose: Treatment
Official Title: A Single-Blind, Randomized, Placebo-Controlled Trial of Human Fecal Microbiota Transplantation for the Therapy of Pediatric Ulcerative Colitis and Inflammatory Bowel Disease Unclassified
Study Start Date : November 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: Fecal Microbiota Enema
Live, healthy, human donor stool prepared as fecal enemas. Fecal enemas are prepared and collected by Rebiotix(®) (RBX2660), using extensively screened donor stool. Enemas will be administered on site at one of the participating trial sites by trained study investigators. Enemas are given: 2x per week for 6 weeks (total = 12 enemas over 6 weeks). Patients will be masked to enema contents.
Biological: Fecal Microbiota Enema
Active intervention.
Other Names:
  • FMT
  • RBX2660
  • Rebiotix
  • Fecal microbial enema

Placebo Comparator: Normal Saline Enema
Normal saline enemas will be administered on site at one of the participating trial sites by trained study investigators. Enemas are given: 2x per week for 6 weeks (total = 12 enemas over 6 weeks). Patients will be masked 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

  6. Urine Metabolomics Change [ Time Frame: Weeks: 0/3/6/12/18/24/30 ]
    Change in urine metabolomics profile (Open Label arm only)



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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 participating clinical trial site: a) McMaster Children's Hospital, b) Children's Hospital at London Health Sciences Centre, c) Centre Hospitalier Universitaire Sainte-Justine
  • Ulcerative colitis (UC) or Inflammatory bowel disease unclassified (IBD-U)
  • Evidence of active clinical, biological, or mucosal disease
  • Ongoing treatment is acceptable provided the patient has had no significant changes to medications, or medication dose for at least 4 weeks prior to starting the trial

Exclusion Criteria:

  • Active participation in another therapeutic trial
  • Unable to give informed consent, or assent
  • Active Clostridium difficile infection
  • Significant change in medication type, or medication dose within the preceding 4 weeks prior to starting the trial
  • Starting new treatments, or having a significant change in medication dosing during the trial
  • Significant, consecutive rise in PUCAI score during the 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


Locations
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Canada, Ontario
McMaster Children's Hospital
Hamilton, Ontario, Canada, L8N 3Z5
Children's Hospital London Health Science Centre
London, Ontario, Canada, N6A 5W9
Canada, Quebec
CHU Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
Sponsors and Collaborators
McMaster Children's Hospital
London Health Sciences Centre
St. Justine's Hospital
Investigators
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Principal Investigator: Nikhil Pai, MD FRCPC McMaster Children's Hospital
Study Director: Jelena Popov, BSc McMaster Children's Hospital Division of Pediatric Gastroenterology & Nutrition
Study Chair: Tim Ramsay, PhD The Ottawa Hospital Research Institute
Additional Information:
Publications of Results:
Other Publications:
Costello SP, Waters O, Bryant RV, et al. Short Duration, Low Intensity, Pooled Fecal Microbiota Transplantation Induces Remission in Patients with Mild-Moderately Active Ulcerative Colitis: A Randomised Controlled Trial. Gastroenterology 152(5): S198-S199, 2017.

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Responsible Party: Nikhil Pai, Assistant Professor, McMaster Children's Hospital
ClinicalTrials.gov Identifier: NCT02487238    
Other Study ID Numbers: 15-364
NIF-15375 ( Other Grant/Funding Number: Hamilton Health Sciences New Investigator Fund 2015 )
HAH-17-002 ( Other Grant/Funding Number: AHSC AFP Innovation Fund 2016-2017 )
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Protocol has been published in BMJ Protocols 2017.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Open-access.
Access Criteria: Pai N, Popov J. Protocol for a randomised, placebo-controlled pilot study for assessing feasibility and efficacy of faecal microbiota transplantation in a paediatric ulcerative colitis population: PediFETCh trial. BMJ Open. 2017;7(8):e016698.
URL: http://bmjopen.bmj.com/content/7/8/e016698
Keywords provided by Nikhil Pai, McMaster Children's Hospital:
Microbiome
Microbiota
Fecal Microbial Transplant
Fecal Microbiota Transplant
FMT
Gastroenterology
IBD
Inflammatory Bowel Disease
Ulcerative Colitis
UC
Inflammatory Bowel Disease Unclassified
IBD-U
Rebiotix
RBX2660
Pediatrics
McMaster Children's Hospital
Centre Hospitalier Universitaire Sainte-Justine
Children's Hospital at London Health Sciences Centre
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes