Status:
TERMINATED
Impact of a Biofeedback Intervention on Microbiome, Metabolome, and Clinical Outcomes in Pediatric IBD (Study 2)
Lead Sponsor:
Nationwide Children's Hospital
Conditions:
IBD
Eligibility:
All Genders
8-17 years
Phase:
NA
Brief Summary
This prospective, randomized, longitudinal, controlled study will enroll pediatric CD patients with inflammatory, non-stricturing, and non-penetrating disease type with mild/quiescent disease based on...
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
- Age 8-17 years
- Have inflammatory, non-stricturing, and non-penetrating CD with either mild/quiescent disease based on PCDAI or PGA
- Live within a 2 hour drive of NCH
Exclusion
- Participants are excluded if they have ulcerative colitis, penetrating and/or stricturing CD, have a comorbid chronic illness, perianal disease, taking antibiotics within the last 3 months, psychological disorders that they are undergoing treatment or taking medication for at that time, presence of a heart rhythm or other abnormality of heart rhythm on screening EKG, 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 :
March 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 14 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04296110
Start Date
March 12 2020
End Date
August 14 2024
Last Update
August 15 2024
Active Locations (1)
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1
Nationwide Childrens Hospital GI Clinic
Columbus, Ohio, United States, 43205