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

IBD Clinical Trial

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

Status Suspended

Clinical Trial 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 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.

Clinical Trial 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 occurs prior to the age of 20. Despite medical advances in new therapies, the clinical remission rate on biologics is less than 50% and a significant number of patients will lose response to anti-TNF therapy over time. In addition, patients that require a change in therapy will have a lower response rate to a different biologic. Additional therapies and mechanisms that affect disease activity need to be investigated to identify complimentary treatments that can further impact remission rates without increasing side effects such as lymphoma.

Environmental factors, such as stressor exposure, can exacerbate mucosal inflammation. Patients with IBD report a lower quality of life, as well as increased anxiety and depression. Psychological interventions may improve disease activity. This study will test, using a randomized clinical trial (RCT) design, whether biofeedback intervention will attenuate disease activity. If efficacious, this study will provide a rationale for establishing biofeedback as a complimentary therapy to standard of care to ameliorate stress-induced increases in chronic inflammation. ;

Related Conditions & MeSH terms

• IBD

• NCT number: NCT04296110
• Study type: Interventional
• Source: Nationwide Children's Hospital
• Status: Suspended
• Phase: N/A
• Start date: March 12, 2020
• Completion date: March 1, 2024