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MICROBIOTA for Crohn's Disease (PediCRaFT Trial)
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.
- Crohn's Disease
- Inflammatory Bowel Disease
PediCRaFT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPediCRaFT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PediCRaFT Trial Design
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Who is running the clinical trial?
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."
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."
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."
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."
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)."
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."
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