Yoga for Patients With Irritable Bowel Syndrome

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Behavioral: Yoga; Behavioral: Nutrition Counselling

• Registration Number: NCT02721836
• Lead Sponsor: Universität Duisburg-Essen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-17
• Study First Submitted QC: 2016-03-22
• Study First Posted: 2016-03-29
• Study Start: 2016-04
• Primary Completion: 2016-12
• Status Verified: 2017-05
• Study Completion: 2017-05
• Last Update Submitted: 2017-05-23
• Last Update Posted: 2017-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yoga	Yoga	12 week yoga course, two times a week 75 minutes each time
Nutrition	Nutrition Counselling	3 counselling sessions within 12 weeks

Primary Outcome Measures

Name	Time	Method
Irritable Bowel Syndrome Symptoms	Week 12	Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universität Duisburg-Essen; 🇩🇪 Essen, Germany