Yoga for Youth With IBD: a Pilot Feasibility Study

Not Applicable

Completed

• Conditions: Yoga; Inflammatory Bowel Diseases; Ulcerative Colitis; Adolescents; Crohn Disease

• Registration Number: NCT04757935
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2017-05-31
• Study Completion: 2017-05-31
• Study First Submitted: 2018-09-06
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-16
• Last Update Submitted: 2021-02-16
• Study First Posted: 2021-02-17
• Last Update Posted: 2021-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Assessment of acceptability	1 hour focus group at conclusion of intervention.	Focus Group

Secondary Outcome Measures

Name	Time	Method
Fecal Calprotectin	6 weeks (Prior to intervention; After conclusion of intervention)	Stool biomarker that indicates intestinal inflammation
PROMIS-37	6 weeks (Prior to intervention; After conclusion of intervention)	NIH Pediatric Assessment Tool
Pediatric Ulcerative Colitis Activity Index	6 weeks (Prior to intervention; After conclusion of intervention)	5 question assessment tool for disease tracking for patient's with ulcerative colitis

Trial Locations

Locations (1)

Lucile Packard Children's Hospital; 🇺🇸 Palo Alto, California, United States