Yoga for Patients With Irritable Bowel Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Controlled Trial on Yoga for Irritable Bowel Syndrome

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Behavioral: Yoga
* Behavioral: Nutrition Counselling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with irritable bowel syndrome (IBS) diagnosed by physician and confirmed by Rome III diagnostic criteria Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga<br>12 week yoga course, two times a week 75 minutes each time | Behavioral: Yoga<br>* Yoga intervention 12 weeks, twice weekly 75-minute intervention Yoga postures, breathing, relaxation, and meditation<br>|
| Active Comparator: Nutrition<br>3 counselling sessions within 12 weeks | Behavioral: Nutrition Counselling<br>* Evidence-based Nutrition Counselling, 3 appointments within 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irritable Bowel Syndrome Symptoms | Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease specific quality of life | Irritable Bowel Syndrome Quality of Life measurement (IBS-QOL) | Week 12 | 
| disease specific quality of life | Irritable Bowel Syndrome Quality of Life measurement (IBS-QOL) | Week 24 | 
| Generic Health-related Quality of life | Short Form 36 Health Survey Questionnaire, SF-36 | Week 12 | 
| Generic Health-related Quality of life | Short Form 36 Health Survey Questionnaire, SF-36 | Week 24 | 
| Emotional distress | Hospital Anxiety and Depression Scale (HADS) | Week 12 | 
| Emotional distress | Hospital Anxiety and Depression Scale (HADS) | Week 24 | 
| Subjective Stress | Cohen Perceived Stress Scale (CPSS) | Week 12 | 
| Subjective Stress | Cohen Perceived Stress Scale (CPSS) | Week 24 | 
| Subjective improvement of symptoms | Adequate Relief Score and Global Improvement Scale (GI) | Week 12 | 
| Subjective improvement of symptoms | Adequate Relief Score and Global Improvement Scale (GI) | Week 24 | 
| Gut microbiome | Stool samples | Week 12 | 
| Adverse Event |  | Week 12 | 
| Adverse Event |  | Week 24 | 
| Irritable Bowel Syndrome Symptoms | Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) | Week 24 |