← Back to Search

Microbiota Therapy

MICROBIOTA for Crohn's Disease (PediCRaFT Trial)

Phase 1
Waitlist Available
Led By Nikhil Pai, BSc, MD
Research Sponsored by McMaster Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pediatric patients
Crohn's disease, or IBD-Unclassified favoring Crohn's disease (as deemed by the patient's primary pediatric gastroenterologist)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6, week 30
Awards & highlights

PediCRaFT Trial Summary

This trial will test whether a combination of colonic and oral fecal microbiota transplantation can improve the disease activity of pediatric Crohn's disease patients.

Eligible Conditions
  • Crohn's Disease
  • Inflammatory Bowel Disease

PediCRaFT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
The clinical trial is not open to children.
Select...
You have Crohn's disease, or a type of inflammatory bowel disease that is suspected to be Crohn's disease by your pediatric gastroenterologist.
Select...
You currently have noticeable symptoms of your medical condition.

PediCRaFT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 6, week 30
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6, week 30 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dropout Rate Post Enrolment
Monthly Recruitment Rate
Rate of Adverse Events
+1 more
Secondary outcome measures
Clinical: Change in Fecal Microbiome
Clinical: Change in Urine Metabolomics
Clinical: Improvement in Disease Symptoms
+3 more

PediCRaFT Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MICROBIOTAExperimental Treatment1 Intervention
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). (n = 30)
Group II: PLACEBOPlacebo Group1 Intervention
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). (n = 15)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MICROBIOTA
2018
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

St. Justine's HospitalOTHER
195 Previous Clinical Trials
79,275 Total Patients Enrolled
McMaster Children's HospitalLead Sponsor
38 Previous Clinical Trials
17,287 Total Patients Enrolled
McMaster Children's Hospital (McMaster University)UNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria makes an individual a viable candidate for this experiment?

"This trial has room for 45 qualified candidates with ileocolitis aged between 3 and 17. In addition, participants must have pediatric Crohn's disease or IBD-Unclassified favouring Crohn's Disease (as determined by the patient's primary gastroenterologist) as well as active symptoms."

Answered by AI

Are individuals younger than 50 years old acceptable to enrol in this clinical research?

"This clinical trial has specific requirements for applicants, stipulating that they must be between 3 and 17 years old. There are 131 different trials available to youngsters under 18 while there are 430 studies directed towards seniors over 65."

Answered by AI

What is the total participant quota for this research endeavor?

"Affirmative. According to clinicaltrials.gov, the research trial which first went live on December 1st 2018 is still accepting new participants. The study seeks 45 individuals from two separate medical locations and was last edited April 23rd 2022."

Answered by AI

Has MICROBIOTA been granted official authorization from the FDA?

"MICROBIOTA's safety rating was given a score of 1 by Power due to the limited amount of data present that supports its efficacy and safety."

Answered by AI

What are the chief objectives of this clinical experimentation?

"This 30-week trial will measure the dropout rates post enrolment and also assess certain clinical outcomes such as a remission in disease symptoms (PCDAI ≤ 10 at Week 6, Week 30), an improvement in mucosal inflammatory markers (decrease fecal calprotectin from baseline - Week 6, Week 30) and improved overall symptom management (PCDAI decrease ≥15 from baseline - week 6, week 30)."

Answered by AI

Are researchers currently seeking participants for this experiment?

"The information accessible on clinicaltrials.gov attests that this medical research is actively seeking volunteers, which was initially published on December 1st 2018 and most recently edited on April 23rd 2022."

Answered by AI
Recent research and studies
~3 spots leftby Mar 2025