Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Yoga for Patients With Irritable Bowel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02721836
Recruitment Status : Completed
First Posted : March 29, 2016
Last Update Posted : May 24, 2017
Sponsor:
Information provided by (Responsible Party):
Dania Schumann, 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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Behavioral: Yoga Behavioral: Nutrition Counselling Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial on Yoga for Irritable Bowel Syndrome
Study Start Date : April 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : May 2017

Arm Intervention/treatment
Experimental: Yoga
12 week yoga course, two times a week 75 minutes each time
Behavioral: Yoga
Yoga intervention 12 weeks, twice weekly 75-minute intervention Yoga postures, breathing, relaxation, and meditation

Active Comparator: Nutrition
3 counselling sessions within 12 weeks
Behavioral: Nutrition Counselling
Evidence-based Nutrition Counselling, 3 appointments within 12 weeks




Primary Outcome Measures :
  1. Irritable Bowel Syndrome Symptoms [ Time Frame: Week 12 ]
    Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)


Secondary Outcome Measures :
  1. disease specific quality of life [ Time Frame: Week 12 ]
    Irritable Bowel Syndrome Quality of Life measurement (IBS-QOL)

  2. disease specific quality of life [ Time Frame: Week 24 ]
    Irritable Bowel Syndrome Quality of Life measurement (IBS-QOL)

  3. Generic Health-related Quality of life [ Time Frame: Week 12 ]
    Short Form 36 Health Survey Questionnaire, SF-36

  4. Generic Health-related Quality of life [ Time Frame: Week 24 ]
    Short Form 36 Health Survey Questionnaire, SF-36

  5. Emotional distress [ Time Frame: Week 12 ]
    Hospital Anxiety and Depression Scale (HADS)

  6. Emotional distress [ Time Frame: Week 24 ]
    Hospital Anxiety and Depression Scale (HADS)

  7. Subjective Stress [ Time Frame: Week 12 ]
    Cohen Perceived Stress Scale (CPSS)

  8. Subjective Stress [ Time Frame: Week 24 ]
    Cohen Perceived Stress Scale (CPSS)

  9. Subjective improvement of symptoms [ Time Frame: Week 12 ]
    Adequate Relief Score and Global Improvement Scale (GI)

  10. Subjective improvement of symptoms [ Time Frame: Week 24 ]
    Adequate Relief Score and Global Improvement Scale (GI)

  11. Gut microbiome [ Time Frame: Week 12 ]
    Stool samples

  12. Adverse Event [ Time Frame: Week 12 ]
  13. Adverse Event [ Time Frame: Week 24 ]
  14. Irritable Bowel Syndrome Symptoms [ Time Frame: Week 24 ]
    Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721836


Locations
Layout table for location information
Germany
Universität Duisburg-Essen
Essen, Germany, 45276
Sponsors and Collaborators
Universität Duisburg-Essen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Dania Schumann, Principal Investigator, Research fellow, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT02721836    
Other Study ID Numbers: 15-6653-BO
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: May 24, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases