Yoga for Patients With Irritable Bowel Syndrome

NCT ID: NCT02721836

Last Updated: 2017-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-05-31

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.

Detailed Description

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Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Yoga

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

Group Type EXPERIMENTAL

Yoga

Intervention Type BEHAVIORAL

Yoga intervention 12 weeks, twice weekly 75-minute intervention Yoga postures, breathing, relaxation, and meditation

Nutrition

3 counselling sessions within 12 weeks

Group Type ACTIVE_COMPARATOR

Nutrition Counselling

Intervention Type BEHAVIORAL

Evidence-based Nutrition Counselling, 3 appointments within 12 weeks

Interventions

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Yoga

Yoga intervention 12 weeks, twice weekly 75-minute intervention Yoga postures, breathing, relaxation, and meditation

Intervention Type BEHAVIORAL

Nutrition Counselling

Evidence-based Nutrition Counselling, 3 appointments within 12 weeks

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universität Duisburg-Essen

OTHER

Sponsor Role lead

Responsible Party

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Dania Schumann

Principal Investigator, Research fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universität Duisburg-Essen

Essen, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 27112106 (View on PubMed)

Other Identifiers

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15-6653-BO

Identifier Type: -

Identifier Source: org_study_id

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