Irritable Bowel SyndromeNCT01107977
Iyengar Yoga for Young People With Irritable Bowel Syndrome
A study testing Iyengar yoga in people with Irritable Bowel Syndrome, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Irritable bowel syndrome (IBS) affects as many as 14% of high school-aged students. Symptoms include discomfort in the abdomen, along with diarrhea and/or constipation and other gastroenterological symptoms, which can significantly impact quality of life and daily functioning of patients. Read more about this study
- Who is it for?
- Ages 14 to 26 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Iyengar yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2013
- 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 14 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male and female youth will be eligible for the study if they meet the following criteria:
- Age 14-26 years.
- Diagnosis of IBS, using ROME III pediatric criteria for patients aged 14-17 years, and ROME III adult criteria for 18-26 year-olds.
- Able and willing to give written informed assent or consent and comply with the requirements of the study protocol.
- Ability to speak and understand English.
Who cannot join
- Any other injury, disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion that it might affect the interpretation of the results or render the patient at high risk from treatment complications.
- Inability to comply with study and follow-up procedures.
- Currently pregnant.
- Previous practice of yoga within the past three months.
- Inability to speak and understand English.
- Plan to begin a new treatment within 2 weeks of the IYP.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Pediatric Pain Program
Los Angeles, California, 90064
About this study
Irritable bowel syndrome (IBS) affects as many as 14% of high school-aged students. Symptoms include discomfort in the abdomen, along with diarrhea and/or constipation and other gastroenterological symptoms, which can significantly impact quality of life and daily functioning of patients. Emotional stress appears to exacerbate IBS symptoms suggesting that mind-body interventions reducing arousal may prove beneficial. Often symptoms can be traced to childhood and adolescence, making the early manifestation of IBS important to understand. The current study focuses on young people aged 14-26 years of age with IBS. The study will test the potential benefits of Iyengar yoga (IY) on clinical symptoms, psychospiritual functioning and visceral sensitivity. Yoga is thought to bring physical, psychological and spiritual benefits to practitioners and has been associated with reduced stress and pain. Through its focus on restoration and use of props, IY is especially designed to decrease arousal and promote psychospiritual resources in physically compromised individuals. Sixty-four IBS patients aged 14-26 will be randomly assigned to a standardized 6-week biweekly IY group-based program (1.5 hour sessions) or a wait-list usual care control group. The groups will be compared on the primary clinical outcomes of IBS symptoms, quality of life and global improvement at post-treatment and 2 month follow-up. Secondary outcomes will include visceral pain sensitivity assessed with a standardized laboratory task (water load task), and psychospiritual variables including coping, self-efficacy, mood, acceptance and mindfulness. It is hypothesized that IY will be safe and feasible: with less than 20% attrition; and the IY group will demonstrate significantly improved outcomes compared to controls, with physiological and psychospiritual mechanisms contributing to improvements; clinical treatment gains will be maintained at 2 months following yoga.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Iyengar yoga
- 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.
Iyengar yogaBehavioural
Iyengar yoga twice/week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Iyengar yoga | Experimental | Not described Receives: Behavioral: Iyengar yoga |
| Waitlist control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irritable bowel symptoms
Measured: baseline (within 2 weeks of receiving intervention)
Irritable bowel symptoms
Measured: post-intervention (within 2 weeks of completing intervention)
Irritable bowel symptoms
Measured: follow up (2 months after completion of intervention)
Quality of Life
Measured: baseline (within 2 weeks of receiving intervention)
Quality of Life
Measured: post-intervention (within 2 weeks of completing intervention)
Quality of Life
Measured: follow up (2 months after completion of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Subhadra Evans, Ph.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107977
- Sponsor's protocol ID
- 1K01AT005093
- Status last verified
- Nov 2016
- First submitted
- 20 Apr 2010
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Evans S, Lung KC, Seidman LC, Sternlieb B, Zeltzer LK, Tsao JC. Iyengar yoga for adolescents and young adults with irritable bowel syndrome. J Pediatr Gastroenterol Nutr. 2014 Aug;59(2):244-53. doi: 10.1097/MPG.0000000000000366.
PubMed 25025601Evans S, Cousins L, Tsao JC, Sternlieb B, Zeltzer LK. Protocol for a randomized controlled study of Iyengar yoga for youth with irritable bowel syndrome. Trials. 2011 Jan 18;12:15. doi: 10.1186/1745-6215-12-15.
PubMed 21244698
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iyengar Yoga for Young People With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT01107977
- Acronym / sponsor ID
- 1K01AT005093
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 Apr 2010 (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.
Irritable bowel syndrome (IBS) affects as many as 14% of high school-aged students. Symptoms include discomfort in the abdomen, along with diarrhea and/or constipation and other gastroenterological symptoms, which can significantly impact quality of life and daily functioning of patients. Emotional stress appears to exacerbate IBS symptoms suggesting that mind-body interventions reducing arousal may prove beneficial. Often symptoms can be traced to childhood and adolescence, making the early manifestation of IBS important to understand. The current study focuses on young people aged 14-26 years of age with IBS. The study will test the potential benefits of Iyengar yoga (IY) on clinical symptoms, psychospiritual functioning and visceral sensitivity. Yoga is thought to bring physical, psychological and spiritual benefits to practitioners and has been associated with reduced stress and pain. Through its focus on restoration and use of props, IY is especially designed to decrease arousal and promote psychospiritual resources in physically compromised individuals. Sixty-four IBS patients aged 14-26 will be randomly assigned to a standardized 6-week biweekly IY group-based program (1.5 hour sessions) or a wait-list usual care control group. The groups will be compared on the primary clinical outcomes of IBS symptoms, quality of life and global improvement at post-treatment and 2 month follow-up. Secondary outcomes will include visceral pain sensitivity assessed with a standardized laboratory task (water load task), and psychospiritual variables including coping, self-efficacy, mood, acceptance and mindfulness. It is hypothesized that IY will be safe and feasible: with less than 20% attrition; and the IY group will demonstrate significantly improved outcomes compared to controls, with physiological and psychospiritual mechanisms contributing to improvements; clinical treatment gains will be maintained at 2 months following yoga.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iyengar yoga | Experimental | Behavioral: Iyengar yoga |
| Waitlist control | No intervention | – |
Who may qualify
- Ages
- 14 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Male and female youth will be eligible for the study if they meet the following criteria:
Key exclusion criteria (6 listed)
- Any other injury, disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion that it might affect the interpretation of the results or render the patient at high risk from treatment complications.
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 |
|---|---|---|
| Iyengar yogaIyengar yoga twice/week for 6 weeks | Behavioural | Iyengar yoga |
Primary outcome
Irritable bowel symptoms
Time frame: baseline (within 2 weeks of receiving intervention)
Irritable bowel symptoms
Time frame: post-intervention (within 2 weeks of completing intervention)
Irritable bowel symptoms
Time frame: follow up (2 months after completion of intervention)
Quality of Life
Time frame: baseline (within 2 weeks of receiving intervention)
Quality of Life
Time frame: post-intervention (within 2 weeks of completing intervention)
Quality of Life
Time frame: follow up (2 months after completion of intervention)
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 28 Nov 2016.
- Results publication: PubMed 25025601Evans S, Lung KC, Seidman LC, Sternlieb B, Zeltzer LK, Tsao JC. Iyengar yoga for adolescents and young adults with irritable bowel syndrome. J Pediatr Gastroenterol Nutr. 2014 Aug;59(2):244-53. doi: 10.1097/MPG.0000000000000366.
- Derived from this study: PubMed 21244698Evans S, Cousins L, Tsao JC, Sternlieb B, Zeltzer LK. Protocol for a randomized controlled study of Iyengar yoga for youth with irritable bowel syndrome. Trials. 2011 Jan 18;12:15. doi: 10.1186/1745-6215-12-15.
Related trials for Irritable Bowel Syndrome
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
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.
Subhadra Evans, Ph.D. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iyengar yoga in people with Irritable Bowel Syndrome, run by University of California, Los Angeles at 1 site in United States.
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 5 inclusion and 6 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 28 Nov 2016. 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 United States. 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 symptoms (time frame: baseline (within 2 weeks of receiving intervention)). The study lists 6 primary outcomes in all. 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 NCT01107977, which also lists 2 linked publications.
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 28 Nov 2016; AzTrials last refreshed its copy on 7 Nov 2026.