Irritable Bowel SyndromeNCT02721836
Yoga for Patients With Irritable Bowel Syndrome
A study testing Yoga and Nutrition Counselling in people with Irritable Bowel Syndrome, run by Universität Duisburg-Essen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Yoga and Nutrition Counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2016to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with irritable bowel syndrome (IBS) diagnosed by physician and confirmed by Rome III diagnostic criteria
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial on Yoga for 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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Yoga, Nutrition Counselling
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
Yoga intervention 12 weeks, twice weekly 75-minute intervention Yoga postures, breathing, relaxation, and meditation
Nutrition CounsellingBehavioural
Evidence-based Nutrition Counselling, 3 appointments within 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Experimental | 12 week yoga course, two times a week 75 minutes each time Receives: Behavioral: Yoga |
| Nutrition | Active comparator | 3 counselling sessions within 12 weeks Receives: Behavioral: Nutrition Counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irritable Bowel Syndrome Symptoms
Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)
Measured: Week 12
Secondary outcomes (14)
disease specific quality of life
Irritable Bowel Syndrome Quality of Life measurement (IBS-QOL)
Measured: Week 12
disease specific quality of life
Irritable Bowel Syndrome Quality of Life measurement (IBS-QOL)
Measured: Week 24
Generic Health-related Quality of life
Short Form 36 Health Survey Questionnaire, SF-36
Measured: Week 12
Generic Health-related Quality of life
Short Form 36 Health Survey Questionnaire, SF-36
Measured: Week 24
Emotional distress
Hospital Anxiety and Depression Scale (HADS)
Measured: Week 12
Emotional distress
Hospital Anxiety and Depression Scale (HADS)
Measured: Week 24
Subjective Stress
Cohen Perceived Stress Scale (CPSS)
Measured: Week 12
Subjective Stress
Cohen Perceived Stress Scale (CPSS)
Measured: Week 24
Subjective improvement of symptoms
Adequate Relief Score and Global Improvement Scale (GI)
Measured: Week 12
Subjective improvement of symptoms
Adequate Relief Score and Global Improvement Scale (GI)
Measured: Week 24
Gut microbiome
Stool samples
Measured: Week 12
Adverse Event
Measured: Week 12
Adverse Event
Measured: Week 24
Irritable Bowel Syndrome Symptoms
Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dania Schumann, Universität Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721836
- Sponsor's protocol ID
- 15-6653-BO
- Status last verified
- May 2017
- First submitted
- 17 Mar 2016
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27112106
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on Yoga for Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT02721836
- Acronym / sponsor ID
- 15-6653-BO
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 29 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Behavioral: Yoga12 week yoga course, two times a week 75 minutes each time |
| Nutrition | Active comparator | Behavioral: Nutrition Counselling3 counselling sessions within 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with irritable bowel syndrome (IBS) diagnosed by physician and confirmed by Rome III diagnostic criteria
Key exclusion criteria (9 listed)
- inflammatory bowel diseases (IBD)
- total abdominal colectomy
- no sonographie or colonoscopy as diagnostic criterion
- stool lactoferrin > 7mg/g
- pregnancy or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YogaYoga intervention 12 weeks, twice weekly 75-minute intervention Yoga postures, breathing, relaxation, and meditation | Behavioural | Yoga |
| Nutrition CounsellingEvidence-based Nutrition Counselling, 3 appointments within 12 weeks | Behavioural | Nutrition |
Primary outcome
Irritable Bowel Syndrome Symptoms
Time frame: Week 12
Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)
14 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
- Derived from this study: PubMed 27112106Schumann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga and Nutrition Counselling in people with Irritable Bowel Syndrome, run by Universität Duisburg-Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Irritable Bowel Syndrome Symptoms (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02721836, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2017.