ClinicalTrials.gov
ClinicalTrials.gov Menu

PediCRaFT: Pediatric Crohn's Disease Fecal Transplant Trial (PediCRaFT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03378167
Recruitment Status : Not yet recruiting
First Posted : December 19, 2017
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Nikhil Pai, McMaster Children's Hospital

Brief Summary:
The objective of this pilot study is to assess the feasibility of a treatment protocol of FMT for the treatment of active pediatric CD. Specifically, we will test the hypothesis that a protocol of combination fecal microbiota colonoscopic infusion and oral microbiota capsules (OMC), using live fecal material from anonymous unrelated donors, can improve the disease activity of pediatric CD patients.

Condition or disease Intervention/treatment Phase
Crohn Disease Pediatric Crohns Disease Inflammatory Bowel Diseases Colitis Biological: MICROBIOTA Biological: PLACEBO Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Patients will be randomized 1:1 to one of two groups upon consent: intervention or control. 14 patients will be randomized to receive an FMT via colonoscopy + oral microbiota capsular (OMC) therapy (INTERVENTION), and 14 patients will be randomized to receive normal saline (NS) via colonoscopy + dextrose-containing oral capsules (oral placebo capsule, OPC) (CONTROL). Randomization will occur through a computer-generated block-randomization pattern (block size = 4 participants).

Patients randomized to the control group will be given the option of receiving open-label treatment, with the intervention therapy, either: upon completion of the trial, or if they are removed from the trial due to disease exacerbation or other adverse event, at the discretion of their primary gastroenterologist.

Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:

COLONOSCOPY:

  1. Microbial enemas are drawn up in a 500cc syringe that is concealed with an opaque bag, used to infuse contents through the colonoscope. This will insure contents are blinded to non-study personnel in the room
  2. Patients randomized to the control study arm will have identical concealment of the 500cc syringe used to infuse contents through the colonoscope. For the NS infusion, study personnel will add an additional 0.75 ml of commercially available (Club House® brand), food-grade food coloring (2 drops red, 3 drops green, 7 drops yellow) to confer a brown color to the clear normal saline solution. This step will maintain blinding for the patient and non-study personnel in the room, as the contents of the liquid will be visible endoscopically, but will still retain a similarly-colored brown appearance akin to human stool.

ORAL CAPSULAR THERAPY:

a), b) The opaque color of both the OMC and OPC will insure that blinding is preserved to the study patient.

Primary Purpose: Treatment
Official Title: PediCRaFT: Pediatric Crohn's Disease Fecal Microbiota Transplant Pilot Study
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MICROBIOTA
Patients randomized to the INTERVENTION arm will receive a baseline fecal microbiota transplant (FMT) colonoscopic infusion at Week 0, followed by twice-weekly oral microbiota capsule (OMC) therapy for 6 weeks (including Week 0).
Biological: MICROBIOTA
Fecal microbiota enema (RBX2660) infused via colonoscope x 1 + oral microbiota capsules (RBX7455) x 6 weeks. The fecal microbiota enema (RBX2660) prepared by Rebiotix has received Health Canada Clinical Trials Application (CTA), and U.S. Food and Drug Administration Investigational New Drug Application (IND) approval for clinical trials in patients with recurrent Clostridium difficile infection, and pediatric inflammatory bowel disease. The human-derived fecal oral microbiota capsule (RBX7455) has received U.S. Food and Drug Administration Investigational New Drug Application (IND) approval for clinical trials in patients with recurrent Clostridium difficile infection.
Other Names:
  • RBX2660
  • RBX7455
  • Fecal microbiota transplant

Placebo Comparator: PLACEBO
Patients randomized to the CONTROL arm will receive a baseline normal saline (NS) colonoscopic infusion at Week 0, followed by twice-weekly dextrose-containing oral placebo capsule (OPC) therapy for 6 weeks (including Week 0).
Biological: PLACEBO

Placebo enema (Normal Saline) infused via colonoscope x 1 + oral placebo capsules (dextrose-containing capsules) x 6 weeks.

NOTE: Patients randomized to the control group will be given the option of receiving open-label treatment, with the intervention therapy, either: upon completion of the trial, or if they are removed from the trial due to disease exacerbation or other adverse event, at the discretion of their primary gastroenterologist.





Primary Outcome Measures :
  1. Monthly Recruitment Rate [ Time Frame: 30 weeks ]
    Assessment of recruitment rate (based on patients meeting all eligibility criteria who were approached for trial entry)

  2. Dropout Rate Post Enrolment [ Time Frame: 30 weeks ]
    Rate of patients leaving the trial (patient, or protocol directed exclusion) after enrolment

  3. Rate of Patient Protocol Adherence [ Time Frame: 30 weeks ]
    Rate of patients providing all required blood, stool and urine samples per protocol

  4. Rate of Adverse Events [ Time Frame: 30 weeks ]
    Rate of patients requiring hospitalization, or experiencing PCDAI increase ≥20 x 2 successive measures


Secondary Outcome Measures :
  1. Clinical: Improvement in Disease Symptoms [ Time Frame: Baseline, Week 6, Week 30 ]
    PCDAI decrease ≥15 from baseline: Week 6, Week 30

  2. Clinical: Remission in Disease Symptoms [ Time Frame: Week 6, Week 30 ]
    PCDAI ≤ 10: Week 6, Week 30

  3. Clinical: Improvement in Serum Inflammatory Markers [ Time Frame: Baseline, Week 6, Week 30 ]
    Decrease C-reactive protein from baseline: Week 6, Week 30

  4. Clinical: Improvement in Mucosal Inflammatory Markers [ Time Frame: Baseline, Week 6, Week 30 ]
    Decrease fecal calprotectin from baseline: Week 6, Week 30

  5. Clinical: Change in Urine Metabolomics [ Time Frame: Baseline, Week 6, Week 30 ]
    Change in urine metabolite profile from baseline: Week 6, Week 30

  6. Clinical: Change in Fecal Microbiome [ Time Frame: Baseline, Week 6, Week 30 ]
    Change in fecal 16s rRNA + metagenomics profile baseline: Week 6, Week 30



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Pediatric patients
  • ≥3yo
  • Crohn's disease, or IBD-Unclassified favoring Crohn's disease (as deemed by the patient's primary pediatric gastroenterologist)
  • Active symptoms

Exclusion Criteria:

  • Currently enrolled in another clinical trial
  • Unable to give informed consent or assent
  • Severe comorbid medical illness (at discretion of patient's primary pediatric gastroenterologist)
  • Concomitant Clostridium difficile infection
  • Severe Crohn's disease flare requiring hospitalization
  • Commenced new, or temporary medical therapies (ie. corticosteroids, antibiotics, prebiotics) within 4 weeks prior to commencing the trial; NB: Weaning doses of corticosteroid will be permitted (≤ 0.25mg/kg/day)

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): NCT03378167


Contacts
Contact: Jelena Popov, BSc, MSc 9053087354 popovj2@mcmaster.ca
Contact: Nikhil Pai, BSc, MD 9055212100 ext 75637 pain@mcmaster.ca

Sponsors and Collaborators
McMaster Children's Hospital
Investigators
Principal Investigator: Nikhil Pai, BSc, MD McMaster Children's Hospital, Division of Pediatric Gastroenterology & Nutrition

Additional Information:
Publications:

Responsible Party: Nikhil Pai, Assistant Professor, Division of Pediatric Gastroenterology & Nutrition, McMaster Children's Hospital
ClinicalTrials.gov Identifier: NCT03378167     History of Changes
Other Study ID Numbers: 0000
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nikhil Pai, McMaster Children's Hospital:
Paediatrics
Pediatrics
Crohn's
Crohn
Microbiome
Microbiota
FMT
Fecal Transplant
Fecal Microbiota Transplant
IBD-U
Inflammatory Bowel Disease Unclassified
Inflammatory Bowel Disease Indeterminate
IBD
Colitis

Additional relevant MeSH terms:
Crohn Disease
Colitis
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases