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Yoga for Patients With Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Yoga
Nutrition Counselling
Sponsored by
Universität Duisburg-Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universität Duisburg-Essen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Yoga

Nutrition

Arm Description

12 week yoga course, two times a week 75 minutes each time

3 counselling sessions within 12 weeks

Outcomes

Primary Outcome Measures

Irritable Bowel Syndrome Symptoms
Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)

Secondary Outcome Measures

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

Full Information

First Posted
March 17, 2016
Last Updated
May 23, 2017
Sponsor
Universität Duisburg-Essen
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1. Study Identification

Unique Protocol Identification Number
NCT02721836
Brief Title
Yoga for Patients With Irritable Bowel Syndrome
Official Title
Randomized Controlled Trial on Yoga for Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität Duisburg-Essen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga
Arm Type
Experimental
Arm Description
12 week yoga course, two times a week 75 minutes each time
Arm Title
Nutrition
Arm Type
Active Comparator
Arm Description
3 counselling sessions within 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Yoga
Intervention Description
Yoga intervention 12 weeks, twice weekly 75-minute intervention Yoga postures, breathing, relaxation, and meditation
Intervention Type
Behavioral
Intervention Name(s)
Nutrition Counselling
Intervention Description
Evidence-based Nutrition Counselling, 3 appointments within 12 weeks
Primary Outcome Measure Information:
Title
Irritable Bowel Syndrome Symptoms
Description
Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
disease specific quality of life
Description
Irritable Bowel Syndrome Quality of Life measurement (IBS-QOL)
Time Frame
Week 12
Title
disease specific quality of life
Description
Irritable Bowel Syndrome Quality of Life measurement (IBS-QOL)
Time Frame
Week 24
Title
Generic Health-related Quality of life
Description
Short Form 36 Health Survey Questionnaire, SF-36
Time Frame
Week 12
Title
Generic Health-related Quality of life
Description
Short Form 36 Health Survey Questionnaire, SF-36
Time Frame
Week 24
Title
Emotional distress
Description
Hospital Anxiety and Depression Scale (HADS)
Time Frame
Week 12
Title
Emotional distress
Description
Hospital Anxiety and Depression Scale (HADS)
Time Frame
Week 24
Title
Subjective Stress
Description
Cohen Perceived Stress Scale (CPSS)
Time Frame
Week 12
Title
Subjective Stress
Description
Cohen Perceived Stress Scale (CPSS)
Time Frame
Week 24
Title
Subjective improvement of symptoms
Description
Adequate Relief Score and Global Improvement Scale (GI)
Time Frame
Week 12
Title
Subjective improvement of symptoms
Description
Adequate Relief Score and Global Improvement Scale (GI)
Time Frame
Week 24
Title
Gut microbiome
Description
Stool samples
Time Frame
Week 12
Title
Adverse Event
Time Frame
Week 12
Title
Adverse Event
Time Frame
Week 24
Title
Irritable Bowel Syndrome Symptoms
Description
Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Universität Duisburg-Essen
City
Essen
ZIP/Postal Code
45276
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27112106
Citation
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.
Results Reference
derived

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Yoga for Patients With Irritable Bowel Syndrome

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