Yoga for Patients With Irritable Bowel Syndrome
Randomized Controlled Trial on Yoga for Irritable Bowel Syndrome
1 other identifier
interventional
59
1 country
1
Brief Summary
The proposed study aims to investigate the feasibility, effectiveness, and perceived benefit of a hatha yoga intervention for patients with irritable bowel syndrome (IBS) compared to nutrition counselling. Further, the potential of both interventions to influence the gut microbiome will be inquired.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2016
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
March 17, 2016
CompletedFirst Posted
Study publicly available on registry
March 29, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedMay 24, 2017
May 1, 2017
8 months
March 17, 2016
May 23, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Irritable Bowel Syndrome Symptoms
Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)
Week 12
Secondary Outcomes (14)
disease specific quality of life
Week 12
disease specific quality of life
Week 24
Generic Health-related Quality of life
Week 12
Generic Health-related Quality of life
Week 24
Emotional distress
Week 12
- +9 more secondary outcomes
Study Arms (2)
Yoga
EXPERIMENTAL12 week yoga course, two times a week 75 minutes each time
Nutrition
ACTIVE COMPARATOR3 counselling sessions within 12 weeks
Interventions
Yoga intervention 12 weeks, twice weekly 75-minute intervention Yoga postures, breathing, relaxation, and meditation
Evidence-based Nutrition Counselling, 3 appointments within 12 weeks
Eligibility Criteria
You may qualify if:
- Patients with irritable bowel syndrome (IBS) diagnosed by physician and confirmed by Rome III diagnostic criteria
You may not qualify if:
- inflammatory bowel diseases (IBD)
- total abdominal colectomy
- no sonographie or colonoscopy as diagnostic criterion
- stool lactoferrin \> 7mg/g
- pregnancy or breast feeding
- simultaneous participation in further clinical intervention trials
- Regular yoga practice or nutrition counselling in the past 12 months
- Planned surgery in the study period
- Serious illness that would interfere with the ability to practice yoga
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universität Duisburg-Essen
Essen, 45276, Germany
Related Publications (1)
Schumann D, Anheyer D, Lauche R, Dobos G, Langhorst J, Cramer H. Effect of Yoga in the Therapy of Irritable Bowel Syndrome: A Systematic Review. Clin Gastroenterol Hepatol. 2016 Dec;14(12):1720-1731. doi: 10.1016/j.cgh.2016.04.026. Epub 2016 Apr 22.
PMID: 27112106DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Research fellow
Study Record Dates
First Submitted
March 17, 2016
First Posted
March 29, 2016
Study Start
April 1, 2016
Primary Completion
December 1, 2016
Study Completion
May 1, 2017
Last Updated
May 24, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share