MICROBIOTA for Crohn's Disease

Phase-Based Progress Estimates
Centre Hospitalier Universitaire Sainte-Justine, University of Montreal, Montréal, CanadaCrohn's Disease+3 MoreMICROBIOTA - Biological
3 - 17
All Sexes
What conditions do you have?

Study 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
  • Pediatric Crohn's Disease
  • Inflammatory Bowel Disease (IBD)

Treatment Effectiveness

Study Objectives

4 Primary · 6 Secondary · Reporting Duration: Week 6, Week 30

30 weeks
Dropout Rate Post Enrolment
Monthly Recruitment Rate
Rate of Adverse Events
Rate of Patient Protocol Adherence
Week 30
Clinical: Change in Fecal Microbiome
Clinical: Change in Urine Metabolomics
Clinical: Improvement in Disease Symptoms
Clinical: Improvement in Mucosal Inflammatory Markers
Clinical: Improvement in Serum Inflammatory Markers
Week 6, Week 30
Clinical: Remission in Disease Symptoms

Trial Safety

Trial Design

2 Treatment Groups

1 of 2
1 of 2

Experimental Treatment

Non-Treatment Group

45 Total Participants · 2 Treatment Groups

Primary Treatment: MICROBIOTA · Has Placebo Group · Phase 1

Experimental Group · 1 Intervention: MICROBIOTA · Intervention Types: Biological
PlaceboComparator Group · 1 Intervention: PLACEBO · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 6, week 30

Who is running the clinical trial?

McMaster Children's HospitalLead Sponsor
34 Previous Clinical Trials
16,036 Total Patients Enrolled
McMaster Children's Hospital (McMaster University)UNKNOWN
Centre Hospitalier Universitaire Sainte-Justine (CHU-SJ) (University of Montreal)UNKNOWN
Nikhil Pai, BSc, MDPrincipal InvestigatorMcMaster Children's Hospital, Division of Pediatric Gastroenterology & Nutrition
Nikhil Pai, BSc, CNSC, MD, FRCPCPrincipal InvestigatorMcMaster Children's Hospital, Division of Pediatric Gastroenterology & Nutrition

Eligibility Criteria

Age 3 - 17 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You currently have noticeable symptoms of your medical condition.
The clinical trial is not open to children.
You have Crohn's disease, or a type of inflammatory bowel disease that is suspected to be Crohn's disease by your pediatric gastroenterologist.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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)." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.