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Completed

NCT Number: NCT02721836

Yoga for Patients With Irritable Bowel Syndrome

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universität Duisburg-Essen

Essen, 45276, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yoga

Behavioral

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

Nutrition Counselling

Behavioral

Evidence-based Nutrition Counselling, 3 appointments within 12 weeks

Primary outcomes

  1. Irritable Bowel Syndrome Symptoms

    Time frame: Week 12

    Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Registry information

Official study title

Randomized Controlled Trial on Yoga for Irritable Bowel Syndrome

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Mar 29, 2016
Registry last updated
May 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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