Clinical trial NCT04757935: Yoga for Youth With IBD: a Pilot Feasibility Study
Official title: The Effects of Yoga on Disease Activity in Youth With Inflammatory Bowel Disease: a Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Yoga
Adolescents
Crohn Disease
Ulcerative Colitis
Keywords: inflammatory bowel disease
adolescent
yoga
mind-body
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 9
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An 8-week yoga intervention to determine the feasibility and acceptability of yoga as a supplemental therapy in the management of inflammatory bowel disease in the adolescent population.

Detailed description: Youth with IBD experience abdominal pain, diarrhea, weight loss, and psychological suffering related to their disease process. While many biologic and non-biologic therapies are available to target the inflammatory component of IBD, youth with IBD could benefit from a more holistic therapy that addresses psychological wellness, which has been shown, in turn, to reduce disease burden. It is known that stress (multiple varieties) leads to IBD flares. It is also known that mind-body intervention reduces stress. The mind-gut connection is widely discussed in medical circles, however, current therapies have not capitalized on it. The investigators would like to know if an easily accessible mind-body intervention (yoga) can improve wellness, lower stress levels, and reduce intestinal inflammation in youth with IBD.

The study will be an 8-week feasibility pilot. Participants will be asked to participate in online yoga videos and in-studio yoga sessions. Participants will be asked to complete multiple surveys throughout the intervention and continue receiving standard care from their primary gastroenterology team.

Eligibility criteria: Inclusion Criteria:

* Age 10-21
* Diagnosis of Crohn's Disease or Ulcerative Colitis
* Patient of a Stanford Children's Health or Stanford-affiliated Pediatric Gastroenterologist
* Ability to attend in-person meetings/training

Exclusion Criteria:

* Initiation of biologic therapy in prior 3 months
* Hospital admission in prior 2 months
* Major surgery in prior 1 month
* PUCAI/PCDAI \>65
* Current pregnancy
* Severe developmental or intellectual disability
* Non-english speaking
* Not participating in another concurrent clinical trial

Primary outcomes:
measure: Assessment of acceptability
timeFrame: 1 hour focus group at conclusion of intervention.
Secondary outcomes:
measure: Fecal Calprotectin
timeFrame: 6 weeks (Prior to intervention; After conclusion of intervention)
measure: Pediatric Ulcerative Colitis Activity Index
timeFrame: 6 weeks (Prior to intervention; After conclusion of intervention)
measure: PROMIS-37
timeFrame: 6 weeks (Prior to intervention; After conclusion of intervention)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital
state: California
Study officials:
affiliation: Clinician Educator at Stanford University
name: Ann Ming Yeh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Jenna Marie Arruda, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: