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

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

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.

Study Overview

• Status: Suspended
• Conditions: IBD
• Intervention / Treatment: Other: Music Relaxation Therapy; Behavioral: Biofeedback

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ross Maltz, MD; Phone Number: 5167764287 614-722-3250; Email: ross.maltz@nationwidechildrens.org
• Study Contact Backup: Name: Madelyn McClinchie; Phone Number: 614-722-3453; Email: Maddy.McClinchie@nationwidechildrens.org

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Childrens Hospital GI Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 15 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 8-17 years
2. Have inflammatory, non-stricturing, and non-penetrating CD with either mild/quiescent disease based on PCDAI or PGA
3. Live within a 2 hour drive of NCH

Exclusion Criteria:

1. 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.
2. Age and language are limited by the demands of the study (questionnaire completion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Participants will receive music relaxation therapy. They will be asked to listen to designated music daily for 12 weeks.	Other: Music Relaxation Therapy; We will determine what genre of music is most relaxing to them and ask them to listen to this type of music using the spotify app for 5-15 mins a day for 12 weeks. If they do not have access to a device that they can listen to spotify on, an ipod will be provided. They will be asked to complete a 2-question survey via Redcap daily that asks them if they have listened to the designated music that day and for how long.; Other Names: MRT
Experimental: 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.	Behavioral: Biofeedback; They will also be taught how to use the biofeedback app and Inner Balance device. Additionally, they will also be educated on the principles of biofeedback and its benefits and taught how to maximize HRV by using self-regulation breathing techniques.They will be given an Inner Balance device, which is an ear sensor that connects to an apple device that measures heart rate variability (HRV) and gives them access to an app that is designed to help them improve their HRV. They will be asked to practice breathing at their resonance frequency using the Inner Balance device daily for 5-15 mins for the duration of the 12-week intervention. Patients and the research coordinator will have access to all of their sessions and results. The research coordinator will monitor compliance via the Heartcloud associated with their device and encourage adherence throughout the intervention.; Other Names: Inner Balance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease activity( Fecal calprotectin)	Fecal calprotectin levels from stool	enrollment to 12 month follow up
Disease Activity (Crohn's disease)	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.	enrollment to 12 month follow up
Stress	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.	enrollment to 12 month follow up
Anxiety	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.	enrollment to 12 month follow up
Pediatric Quality of Life: scale	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.	enrollment to 12 month follow up
Depression	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.	enrollment to 12 month follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress-related changes in the microbiome	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.	enrollment to 12 month follow up
Stress-related changes in the metabolome.	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).	enrollment to 12 month follow up

Collaborators and Investigators

• Sponsor: Nationwide Children's Hospital
• Investigators: Principal Investigator: Ross Maltz, MD, Nationwide Childrens Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2020
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: March 3, 2020
• First Submitted That Met QC Criteria: March 4, 2020
• First Posted (Actual): March 5, 2020

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: biofeedback; pediatric
• Other Study ID Numbers: 18-01100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No