Impact of a Biofeedback Intervention on Microbiome, Metabolome, and Clinical Outcomes in Pediatric IBD
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Primary Endpoint
- Ulcerative Colitis Mucosal healing
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The inclusion criteria for Phase 1 are:
- •Age 8-17 years
- •Referred for a diagnostic colonoscopy with strong clinical concern for IBD
- •Live within a 2 hour drive of NCH
- •There is one additional inclusion criterion for Phase 2:
- •Patients have been diagnosed with IBD
Exclusion Criteria
- •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.
- •Age and language are limited by the demands of the study (questionnaire completion)
Arms & Interventions
Control
Participants will not receive biofeedback intervention.
Biofeedback
Participants will receive a biofeedback intervention daily for 8 weeks. Each biofeedback session lasts approximately 10 minutes.
Intervention: Biofeedback (Behavioral)
Outcomes
Primary Outcomes
Ulcerative Colitis Mucosal healing
Time Frame: pre-diagnosis to 12 month follow up
Mayo endoscopic scores for the degree of ulceration. Scores range from 0-3. Higher scores indicate worse inflammation.
Disease activity( Fecal calprotectin)
Time Frame: pre diagnosis to 12 month follow up
Fecal calprotectin levels from stool
Crohn's disease mucosal healing
Time Frame: pre-diagnosis to 12 month follow up
Simple endoscopic score for CD (SES-CD) scores ileum, right colon, transverse, left colon, and rectum for the degree of ulceration. Scale ranges from 0-3, total score is calculated from sum of all variables for all 5 locations. Scores range from 0-60. Higher scores indicate worse inflammation.
Disease Activity (Crohn's disease)
Time Frame: pre diagnosis 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 pre-diagnosis, post-intervention, 4 months post-intervention, and 12 month follow up. Higher scores indicate more severe disease. Scores range from 0-100.
Disease Activity ( Ulcerative Colitis)
Time Frame: pre diagnosis to 12 month follow up
Pediatric Ulcerative Colitis Activity Index total score. A standard Pediatric Ulcerative Colitis Activity Index. a standard measure of disease severity that is comprised pain severity, stool frequency and consistency, rectal bleeding, nocturnal bowel movements, and limitation of activities. The Pediatric Ulcerative Colitis Activity Index total score will be used from pre-diagnosis, post-intervention, 4 months post-intervention, and 12 month follow up. Higher scores indicate more severe disease. Scores range from 0-85.
Stress
Time Frame: pre-diagnosis 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 pre-diagnosis, post-intervention, 4 months post-intervention, and 12 month follow up.
Anxiety
Time Frame: pre-diagnosis 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 pre-diagnosis, post-intervention, 4 months post-intervention, and 12 month follow up.
Pediatric Quality of life
Time Frame: pre-diagnosis 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 pre-diagnosis, post-intervention, 4 months post-intervention, and 12 month follow up.
Depression
Time Frame: pre-diagnosis 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 pre-diagnosis, post-intervention, 4 months post-intervention, and 12 month follow up.
Secondary Outcomes
- Stress-related changes in the microbiome(pre diagnosis to 12 month follow up)
- Stress-related changes in the metabolome.(pre diagnosis to 12 month follow up)
Investigators
Ross Maltz
Principal Investigator
Nationwide Children's Hospital