Meditation and Yoga for Irritable Bowel Syndrome
MY-IBS
1 other identifier
interventional
79
1 country
1
Brief Summary
Study Aim: This study will explore the feasibility and effectiveness of a yoga program for patients with IBS. Methods: A superiority RCT with 30 participants per group. Adult patients with IBS fluent in English who do not have major physical impairments or cognitive, psychological, or psychiatric disorder will be recruited and randomly using the REDCap randomization module to either a yoga intervention delivered (a) a yoga intervention delivered online led by a yoga facilitator or (b) a advice only control group. The 8-week Hatha Yoga intervention consists of Yoga Namaskar, Nadi Shuddhi (alternate nostril breathing), mantra chanting, and breath watching. Group 1: Yoga program. Participants will be asked to practice the yoga program daily at home and will be given access to the yoga videos hosted on the University of Calgary study website, as well as written program instructions, and frequently answered questions. A brief description of the video content will be provided to inform the participant of its content and length. Additional website content will include study information, study schedule, and contact information, as well as a pre-recorded educational session. In addition to the daily program describe above, the facilitator-led intervention will be delivered online by a certified yoga facilitator using the Microsoft Teams platform. Participants in group of 3 to 5 will be collated to enhance effectiveness of the study processes. Our team has experience with this approach, as this strategy is currently used with previous yoga study. Yoga classes will be held once per week for 8 weeks, with the first session lasting approximately 1.5 hours and subsequent sessions up to 60 minutes. The total allocated time for the introductory session will include the class set-up, introductions, educational material (please see below), overview of practices, teaching of practices, practice corrections/enhancements, modifications, and practice expectations. Each follow-up class will include review from the previous week, questions and answers, individual corrections and/or modifications. For individual corrections, the yoga facilitator will ask the participant to do the practices and receive corrections, if needed. Group 2. Advice-only control group. This group will receive general education on IBS, the mind and gut connection, and the role of mind-body therapies in the management of IBS. Effectiveness outcomes will be assessed at baseline and 8 weeks. The primary effectiveness outcome will be the severity of IBS symptoms, and secondary effectiveness outcomes include microbiome analysis, quality of life, anxiety and depression symptoms, perceived stress, fatigue, and severity of somatic symptoms. Microbiome composition will be measured using shotgun metagenomic sequencing. Microbiome sequences will be analyzed for alpha diversity, beta diversity, species composition, functional composition and biomarker discovery. To determine the feasibility of each intervention, recruitment and attrition rates, adherence, program preferences and satisfaction, and adverse event outcomes will be evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 29, 2020
CompletedFirst Posted
Study publicly available on registry
March 10, 2020
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 14, 2022
CompletedMay 3, 2022
April 1, 2022
11 months
February 29, 2020
April 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
IBS-Symptom Severity Scale
Scores range from 0 to 500 with higher scores indicating more severe symptoms. Symptom reduction of at least 50 points is considered clinically meaningful; however, the primary endpoint will be the proportion of participants in each group who demonstrate a symptom reduction of 83 points or more, based on the variables used in the sample size calculation.
Baseline and 8 weeks
Secondary Outcomes (15)
IBS-Quality of Life
Baseline and 8 weeks
Generalized Anxiety Disorder
Baseline and 8 weeks
Patient Health Questionnaire-9 (Depression)
Baseline and 8 weeks
Perceived Stress Scale
Baseline and 8 weeks
Modified Fatigue Impact Scale-21
Baseline and 8 weeks
- +10 more secondary outcomes
Study Arms (2)
Online yoga program
EXPERIMENTALAn 8-week online live facilitator-led yoga program.
Control
EXPERIMENTALAdvice only group.
Interventions
Upa Yoga program consisting of physical postures, breathing techniques, chanting, and meditation.
Eligibility Criteria
You may qualify if:
- A diagnosis of IBS based on Rome IV criteria
- At least 18 years old
- Adequate understanding of English
- Ability to provide written informed consent
- No changes in IBS medication (including anti-depressants), diet, or physical activity levels for at least 8 weeks prior to starting the intervention
You may not qualify if:
- Major physical impairment that would prevent the individual from doing yoga
- Diagnosis of any major cognitive, psychological, or psychiatric disorder (diagnosed before or during the intervention) as identified by the treating physician/healthcare practitioner or screened by the study coordinator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Calgary
Calgary, Alberta, T2N 4Z6, Canada
Related Publications (2)
D'Silva A, Marshall DA, Vallance JK, Nasser Y, Rajagopalan V, Szostakiwskyj JH, Raman M. Meditation and Yoga for Irritable Bowel Syndrome: A Randomized Clinical Trial. Am J Gastroenterol. 2023 Feb 1;118(2):329-337. doi: 10.14309/ajg.0000000000002052. Epub 2022 Oct 11.
PMID: 36422517DERIVEDD'Silva A, Marshall DA, Vallance J, Nasser Y, Rajagopalan V, MacKean G, Raman M. Meditation and yoga for irritable bowel syndrome: study protocol for a randomised clinical trial (MY-IBS study). BMJ Open. 2022 May 26;12(5):e059604. doi: 10.1136/bmjopen-2021-059604.
PMID: 35618329DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maitreyi Raman, MD
University of Calgary
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 29, 2020
First Posted
March 10, 2020
Study Start
March 1, 2021
Primary Completion
January 14, 2022
Study Completion
January 14, 2022
Last Updated
May 3, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- The data will be shared when the manuscript has been published and the graduate student leading this study has defended their thesis (approximately Fall 2022). The data will be available for six months.
- Access Criteria
- Future collaboration (e.g., systematic review/meta-analysis).
Deidentified participant data will be made available upon reasonable request from the study principal investigator.