Impact of a Biofeedback Intervention on Microbiome, Metabolome, and Clinical Outcomes in Pediatric IBD (Study 2)

Stopped early · Not applicable

Conditions studied: IBD

In brief

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 Pediatric Crohn's Disease Activity Index (PCDAI). Participants will be randomized to receive HRV biofeedback intervention daily for 12 weeks or to music relaxation therapy.

Key facts

Study ID

NCT04296110

Run by

Nationwide Children's Hospital

People needed

48

Starts

2020-03-12

Expected to finish

2024-08-14

Last updated by the study team

2024-08-15

Who can join

Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Nationwide Childrens Hospital GI Clinic — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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