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NCT02721836 Clinical Trial

Yoga for Patients With Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:
Randomized Controlled Trial on Yoga for Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02721836
Other study ID # 15-6653-BO
Secondary ID
Status Completed
Phase N/A
First received March 17, 2016
Last updated May 23, 2017
Start date April 2016
Est. completion date May 2017

Study information
Verified date May 2017
Source Universität Duisburg-Essen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 59
Est. completion date May 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Behavioral:
• Yoga
Yoga intervention 12 weeks, twice weekly 75-minute intervention Yoga postures, breathing, relaxation, and meditation
• Nutrition Counselling
Evidence-based Nutrition Counselling, 3 appointments within 12 weeks

Locations
Country Name City State
Germany Universität Duisburg-Essen Essen

Sponsors (1)
Lead Sponsor Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

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