Yoga for Youth With IBD: a Pilot Feasibility Study

Ulcerative Colitis Clinical Trial

Official title:

The Effects of Yoga on Disease Activity in Youth With Inflammatory Bowel Disease: a Pilot Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04757935
• Other study ID #: IRB Protocol 37755
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: May 31, 2017

Study information

• Verified date: February 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescents
• Colitis, Ulcerative
• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis
• Yoga

Intervention

Behavioral:
• Yoga
Yoga for 30 minutes three times weekly for 8 weeks in addition to three, 1-hour in-studio yoga sessions.

Locations

Country	Name	City	State
United States	Lucile Packard Children's Hospital	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of acceptability	Focus Group	1 hour focus group at conclusion of intervention.
Secondary	Fecal Calprotectin	Stool biomarker that indicates intestinal inflammation	6 weeks (Prior to intervention; After conclusion of intervention)
Secondary	Pediatric Ulcerative Colitis Activity Index	5 question assessment tool for disease tracking for patient's with ulcerative colitis	6 weeks (Prior to intervention; After conclusion of intervention)
Secondary	PROMIS-37	NIH Pediatric Assessment Tool	6 weeks (Prior to intervention; After conclusion of intervention)