Status:
WITHDRAWN
Biofeedback in Pediatric Inflammatory Bowel Disease
Lead Sponsor:
Ross Maltz
Conditions:
IBD
Eligibility:
All Genders
8-17 years
Phase:
NA
Brief Summary
This prospective, randomized, longitudinal, controlled project will occur in two phases. Phase 1 is the pre-diagnosis data collection for treatment-naïve participants who are referred for a diagnostic...
Detailed Description
The inflammatory bowel diseases (IBD), which include Crohn's disease (CD) and ulcerative colitis (UC), affects 3 million Americans. In approximately 25-30% of patients, onset of these chronic diseases...
Eligibility Criteria
Inclusion
- The inclusion criteria for Phase 1 are:
- Age 8-17 years
- Referred for a diagnostic colonoscopy with strong clinical concern for IBD
- Live within a 2 hour drive of NCH
- There is one additional inclusion criterion for Phase 2:
- 1\. Patients have been diagnosed with IBD
Exclusion
- Participants are excluded if they have a comorbid chronic illness, perianal disease, current corticosteroid treatment, taking antibiotics within the last 3 months, psychological disorders that they are undergoing treatment or taking medication for at that time, or undergoing psychological treatments such as cognitive behavioral therapy, mindfulness, or biofeedback therapy at the time of enrollment.
- Age and language are limited by the demands of the study (questionnaire completion)
Key Trial Info
Start Date :
September 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04269720
Start Date
September 9 2022
End Date
February 1 2025
Last Update
December 23 2022
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