Clinical trial NCT04269720: Biofeedback in Pediatric Inflammatory Bowel Disease
Official title: Impact of a Biofeedback Intervention on Microbiome, Metabolome, and Clinical Outcomes in Pediatric IBD
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: IBD
Keywords: biofeedback
pediatric
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 0
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 project will occur in two phases. Phase 1 is the pre-diagnosis data collection for treatment-naïve participants who are referred for a diagnostic endoscopy/colonoscopy due to suspicion of IBD. Phase 2 (RCT) is only for patients who are diagnosed with IBD. These patients will be randomized to receive biofeedback intervention daily for 8 weeks or no biofeedback intervention. All participants will receive physician directed standard of care treatment.

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:

The inclusion criteria for Phase 1 are:

1. Age 8-17 years
2. Referred for a diagnostic colonoscopy with strong clinical concern for IBD
3. Live within a 2 hour drive of NCH

There is one additional inclusion criterion for Phase 2:

1. Patients have been diagnosed with IBD

Exclusion Criteria:

1. Participants are excluded if they have a comorbid chronic illness, perianal disease, current corticosteroid treatment, taking antibiotics within the last 3 months, psychological disorders that they are undergoing treatment or taking medication for at that time, 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: Crohn's disease mucosal healing
timeFrame: pre-diagnosis to 12 month follow up
measure: Ulcerative Colitis Mucosal healing
timeFrame: pre-diagnosis to 12 month follow up
measure: Disease activity( Fecal calprotectin)
timeFrame: pre diagnosis to 12 month follow up
measure: Disease Activity (Crohn's disease)
timeFrame: pre diagnosis to 12 month follow up
measure: Disease Activity ( Ulcerative Colitis)
timeFrame: pre diagnosis to 12 month follow up
measure: Stress
timeFrame: pre-diagnosis to 12 month follow up
measure: Anxiety
timeFrame: pre-diagnosis to 12 month follow up
measure: Pediatric Quality of life
timeFrame: pre-diagnosis to 12 month follow up
measure: Depression
timeFrame: pre-diagnosis to 12 month follow up.
Secondary outcomes:
measure: Stress-related changes in the microbiome
timeFrame: pre diagnosis to 12 month follow up
measure: Stress-related changes in the metabolome.
timeFrame: pre diagnosis to 12 month follow up
Other outcomes:
Locations:
Study officials:
affiliation: Nationwide Children's Hospital
name: Ross Maltz, MD
role: PRINCIPAL_INVESTIGATOR
References: