Clinical trial NCT04296110: Impact of a Biofeedback Intervention on Microbiome, Metabolome, and Clinical Outcomes in Pediatric IBD (Study 2)
Official title: Impact of a Biofeedback Intervention on Microbiome, Metabolome, and Clinical Outcomes in Pediatric IBD(Study 2).
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: IBD
Keywords: biofeedback
pediatric
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 48
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disease activity( Fecal calprotectin)
timeFrame: enrollment to 12 month follow up
measure: Disease Activity (Crohn's disease)
timeFrame: enrollment to 12 month follow up
measure: Stress
timeFrame: enrollment to 12 month follow up
measure: Anxiety
timeFrame: enrollment to 12 month follow up
measure: Pediatric Quality of Life: scale
timeFrame: enrollment to 12 month follow up
measure: Depression
timeFrame: enrollment to 12 month follow up
Secondary outcomes:
measure: Stress-related changes in the microbiome
timeFrame: enrollment to 12 month follow up
measure: Stress-related changes in the metabolome.
timeFrame: enrollment to 12 month follow up
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Childrens Hospital GI Clinic
state: Ohio
Study officials:
affiliation: Nationwide Childrens Hospital
name: Ross Maltz, MD
role: PRINCIPAL_INVESTIGATOR
References: