Overview

This trial is active, not recruiting.

Condition irritable bowel syndrome
Treatments yoga, nutrition counselling
Sponsor Universität Duisburg-Essen
Start date April 2016
End date December 2016
Trial size 59 participants
Trial identifier NCT02721836, 15-6653-BO

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
12 week yoga course, two times a week 75 minutes each time
yoga
Yoga intervention 12 weeks, twice weekly 75-minute intervention Yoga postures, breathing, relaxation, and meditation
(Active Comparator)
3 counselling sessions within 12 weeks
nutrition counselling
Evidence-based Nutrition Counselling, 3 appointments within 12 weeks

Primary Outcomes

Measure
Irritable Bowel Syndrome Symptoms
time frame: Week 12

Secondary Outcomes

Measure
disease specific quality of life
time frame: Week 12
disease specific quality of life
time frame: Week 24
Generic Health-related Quality of life
time frame: Week 12
Generic Health-related Quality of life
time frame: Week 24
Emotional distress
time frame: Week 12
Emotional distress
time frame: Week 24
Subjective Stress
time frame: Week 12
Subjective Stress
time frame: Week 24
Subjective improvement of symptoms
time frame: Week 12
Subjective improvement of symptoms
time frame: Week 24
Gut microbiome
time frame: Week 12
Adverse Event
time frame: Week 12
Adverse Event
time frame: Week 24
Irritable Bowel Syndrome Symptoms
time frame: Week 24

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Randomized Controlled Trial on Yoga for Irritable Bowel Syndrome
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Universität Duisburg-Essen.