Impact of a Biofeedback Intervention on Microbiome, Metabolome, and Clinical Outcomes in Pediatric IBD (Study 2)
- Conditions
- IBD
- Interventions
- Behavioral: BiofeedbackOther: Music Relaxation Therapy
- Registration Number
- NCT04296110
- Lead Sponsor
- Nationwide Children's Hospital
- 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 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.
- 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 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 48
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Biofeedback Biofeedback Participants will receive a biofeedback intervention. They will be asked to practice breathing at their designated resonance frequency using provided biofeedback device daily for 12 weeks. Control Music Relaxation Therapy Participants will receive music relaxation therapy. They will be asked to listen to designated music daily for 12 weeks.
- Primary Outcome Measures
Name Time Method Pediatric Quality of Life: scale enrollment to 12 month follow up PedsQL. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used from baseline, post-intervention, 3 months post-intervention, and 12 month follow up.
Disease activity( Fecal calprotectin) enrollment to 12 month follow up Fecal calprotectin levels from stool
Anxiety enrollment to 12 month follow up PROMIS Pediatric Anxiety Short Form. Scores range from 0-60, with higher scores indicating higher levels of anxiety. Total score will be used from baseline, post-intervention, 3 months post-intervention, and 12 month follow up.
Depression enrollment to 12 month follow up Children's Depression Inventory short form. Scores range from 0-54, with higher scores indicating higher levels of depression. Total score will be used from baseline, post-intervention, 3 months post-intervention, and 12 month follow up.
Disease Activity (Crohn's disease) enrollment to 12 month follow up Pediatric Crohn's Disease Activity Index total score. A standard measure of disease severity that is comprised of information obtained from patient recall (pain severity, stool frequency, limitation of activities), examination (weight, height, abdominal tenderness, perirectal disease, extra- intestinal manifestations), and laboratory data. The Pediatric Crohn's Disease Activity Index total score will be used from baseline, post-intervention, 3 months post-intervention, and 12 month follow up. Higher scores indicate more severe disease. Scores range from 0-100.
Stress enrollment to 12 month follow up PROMIS Pediatric Psychological Stress Experiences.Scores range from 0-60, with higher scores indicating higher levels of stress.Total score will be used from baseline, post-intervention, 3 months post-intervention, and 12 month follow up.
- Secondary Outcome Measures
Name Time Method Stress-related changes in the microbiome enrollment to 12 month follow up Microbiome α and β-diversity will be examined at baseline, post-intervention, 3 month post-intervention, and 12 month follow-up to determine possible relationships between overall community structure between participants that received the intervention of biofeedback vs participants that were controls.
Stress-related changes in the metabolome. enrollment to 12 month follow up Random Forest (RF) and Boruta feature selection will be used from baseline, post-intervention, 3 month post-intervention, and 12 month follow-up to identify metabolites and microbes.To further interpret the biological function of predictive metabolites, pathway enrichment analysis will be performed using the RaMP database, which integrates biological pathway and metabolite annotions from multiple sources (e.g. HMDB, KEGG, REACTOME, WikiPathways).
Trial Locations
- Locations (1)
Nationwide Childrens Hospital GI Clinic
🇺🇸Columbus, Ohio, United States