Yoga & Meditation for Irritable Bowel Syndrome

Overseen By Basant Pradhan, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: The Cooper Health System

Disqualifiers: Under 12, Over 21, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether yoga and meditation can reduce anxiety and improve the quality of life for kids and young adults with Irritable Bowel Syndrome (IBS). IBS often causes recurring belly pain and unusual bathroom habits, which can be stressful and affect daily life. Participants will follow a 6-week program at home, practicing yoga twice a week using online videos. Kids and young adults aged 12-21 with IBS, who can access the internet, are a good fit for this trial. As an unphased trial, this study offers a unique opportunity to explore alternative therapies that may enhance well-being and manage IBS symptoms.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this Yoga & Meditation Program is safe for children with IBS?

Research has shown that yoga is safe for people with Irritable Bowel Syndrome (IBS). One study found that an 8-week online yoga program was safe and manageable for IBS patients, allowing them to follow it without issues. Another study reported similar findings, indicating that online yoga did not cause any safety problems for participants. Overall, yoga is well-tolerated and does not cause harmful effects in people with IBS. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard medications for Irritable Bowel Syndrome (IBS) that often include antispasmodics, laxatives, or antidepressants, yoga offers a holistic, non-pharmaceutical approach. Researchers are excited about yoga for IBS because it targets stress and anxiety, which are known triggers for IBS symptoms, through mindful movements and breathing techniques. This method not only aims to alleviate physical discomfort but also enhances overall mental well-being, offering a dual benefit without the side effects that can accompany traditional medications.

What evidence suggests that yoga might be an effective treatment for IBS?

Research has shown that yoga might help people with Irritable Bowel Syndrome (IBS) by easing symptoms and reducing anxiety. Studies suggest that practicing yoga can lessen bowel problems and the severity of IBS. Some research also indicates that yoga can enhance mental health by lowering anxiety, which often accompanies IBS. However, not all studies agree on its effectiveness, with some showing mixed results. Overall, yoga is considered a safe option that could improve the quality of life for those with IBS. Participants in this trial will engage in yoga as the sole treatment arm, serving as their own controls to assess symptom changes before and after participation. ^{1 6 7 8 9}

Who Is on the Research Team?

Alla Kushnir, MD

Principal Investigator

The Cooper Health System

Are You a Good Fit for This Trial?

This trial is for adolescents aged 12-21 with any type of Irritable Bowel Syndrome (IBS) who are patients at Cooper Pediatric Gastroenterology in Voorhees or Camden, NJ. They must be able to access the internet to watch yoga videos and commit to completing at least 4 out of the 6 modules.

Inclusion Criteria

Patients of Cooper Pediatric Gastroenterology practice in Voorhees, NJ

Subjects must be able to access the internet to be able to watch the yoga videos on Youtube

Patients must complete 4 out of 6 modules to stay in the study

Exclusion Criteria

I am over 21 years old.

I am younger than 12 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 6-week, at-home, twice per week Standardized Yoga & Meditation Program for Stress Reduction

6 weeks

Online participation

Follow-up

Participants are monitored for changes in anxiety, IBS symptoms, and quality of life after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Yoga

Trial Overview The study tests a Standardized Yoga & Meditation Program designed for stress reduction in young IBS patients. Over six weeks, participants will follow this program twice weekly at home, aiming to reduce anxiety and improve their quality of life.

How Is the Trial Designed?

Group I: IBS Patients Doing Yoga Experimental Treatment 1 Intervention

All patients will fall under the arm of "IBS Patients Doing Yoga" and will follow the yoga videos that are assigned to them during the study. The participants are their own controls and their symptom changes will be recorded pre- and post-video watching and participation.

Who Is Running the Clinical Trial?

The Cooper Health System

Lead Sponsor

Trials

82

Recruited

35,600+

Published Research Related to This Trial

A short course of Preksha Dhyana (PD), a child-friendly meditation technique combined with yoga, significantly improved pain severity and anxiety in children with IBS, with 93% of participants experiencing pain improvement.

The PD program was successfully integrated into a busy pediatric office setting, showing high completion rates and cost-effectiveness without increasing overall healthcare utilization compared to traditional treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Short Course of Preksha Dhyana for Functional Abdominal Pain Disorder in a Busy Pediatric Clinic. Mehta, V., Mehta, A., Patel, S., et al.[2021]

A one-year follow-up study with 10 out of 13 original participants showed that Relaxation Response Meditation (RRM) significantly reduced IBS symptoms, including abdominal pain, diarrhea, flatulence, and bloating.

Continued practice of RRM led to further reductions in pain and bloating from the three-month follow-up to the one-year mark, indicating its effectiveness as a long-term treatment for IBS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A one year follow-up of relaxation response meditation as a treatment for irritable bowel syndrome. Keefer, L., Blanchard, EB.[2019]

In a study of 22 males with diarrhea-predominant irritable bowel syndrome (IBS), both yogic and conventional treatments significantly reduced bowel symptoms and state anxiety over 2 months.

The yogic intervention showed enhanced parasympathetic reactivity, suggesting a potentially better mechanism for managing IBS symptoms compared to conventional treatment, which improved gastric activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yogic versus conventional treatment in diarrhea-predominant irritable bowel syndrome: a randomized control study. Taneja, I., Deepak, KK., Poojary, G., et al.[2022]

In an 8-week mindfulness-based stress reduction (MBSR) program involving 68 adults with irritable bowel syndrome (IBS), 71% of participants reported significant improvements in gastrointestinal symptoms and quality of life.

The study found that enhancing the 'Act with Awareness' aspect of mindfulness was the strongest predictor of these improvements, suggesting that focusing on the present moment can be particularly beneficial for individuals with IBS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction improves irritable bowel syndrome (IBS) symptoms via specific aspects of mindfulness. Naliboff, BD., Smith, SR., Serpa, JG., et al.[2021]

A 6-week Iyengar yoga program significantly improved IBS symptoms and overall functioning in young adults (ages 18-26), with benefits in psychological distress, sleep quality, and fatigue, compared to a usual-care waitlist group of 22 participants.

While adolescents (ages 14-17) showed improved physical functioning, the overall benefits of yoga were more pronounced in young adults, suggesting that yoga may be more effective when tailored to the developmental stage of the participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iyengar yoga for adolescents and young adults with irritable bowel syndrome. Evans, S., Lung, KC., Seidman, LC., et al.[2021]

Yoga is shown to be an effective and safe therapy for Irritable Bowel Syndrome (IBS), outperforming pharmacological treatments and matching the effectiveness of dietary changes and moderate exercise, based on evidence from randomized controlled trials.

Improvements from yoga practice were noted in both physical health (like symptom severity and gastric motility) and mental health (including reductions in anxiety and depression), although the overall quality of evidence is limited due to variability in study designs and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga as a Therapy for Irritable Bowel Syndrome. D'Silva, A., MacQueen, G., Nasser, Y., et al.[2022]

A virtual Hatha yoga program significantly reduced IBS symptoms in participants, with a notable decrease in the IBS Symptom Severity Scale (IBS-SSS) by an average of 54.7 points, compared to a smaller change in the control group.

The yoga intervention also improved quality of life, fatigue, and perceived stress among participants, demonstrating its feasibility and safety, although it was not found to be superior to the advice-only control group in terms of overall IBS symptom reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meditation and Yoga for Irritable Bowel Syndrome: A Randomized Clinical Trial. D'Silva, A., Marshall, DA., Vallance, JK., et al.[2023]

The study will investigate the effects of Iyengar yoga on irritable bowel syndrome (IBS) symptoms in 60 participants aged 14-26, with a focus on clinical outcomes, quality of life, and psychospiritual functioning over a 6-week period.

It is hypothesized that participants practicing yoga will experience significant improvements in IBS symptoms and related factors, with mechanisms including reduced visceral sensitivity and better stress regulation contributing to these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a randomized controlled study of Iyengar yoga for youth with irritable bowel syndrome. Evans, S., Cousins, L., Tsao, JC., et al.[2021]

A systematic review of six randomized controlled trials involving patients with irritable bowel syndrome (IBS) found that mindfulness meditation significantly improved quality of life and reduced pain scores compared to control groups.

The mindfulness group showed a notable increase in spiritual awareness and a decrease in IBS symptom severity, indicating that mind-body interventions can be effective in managing IBS symptoms and enhancing overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meditation and Irritable Bowel Syndrome, a Systematic Review and Meta-Analysis. Baboș, CI., Leucuța, DC., Dumitrașcu, DL.[2022]

Yoga has been shown to significantly reduce bowel symptoms, IBS severity, and anxiety in patients with irritable bowel syndrome (IBS), based on a systematic review of six randomized controlled trials involving 273 patients.

The review suggests that yoga may improve quality of life and physical functioning for IBS patients, and it appears to be a safe adjunctive treatment, as no adverse events were reported in the studies analyzed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Yoga in the Therapy of Irritable Bowel Syndrome: A Systematic Review. Schumann, D., Anheyer, D., Lauche, R., et al.[2018]

This study will evaluate the effectiveness of an 8-week virtual yoga and meditation program for managing irritable bowel syndrome (IBS) symptoms, comparing it to an advice-only control group, with outcomes assessed at baseline, 4 weeks, and 8 weeks.

The trial will also assess feasibility through recruitment and retention rates, participant satisfaction, and safety, aiming to provide insights into the potential of virtual yoga as a therapeutic option for IBS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meditation and yoga for irritable bowel syndrome: study protocol for a randomised clinical trial (MY-IBS study). D'Silva, A., Marshall, DA., Vallance, J., et al.[2022]

Hypnosis, used as an adjunct therapy for irritable bowel syndrome (IBS), has shown significant improvement in symptoms and quality of life for patients, with most experiencing lasting benefits after up to 12 sessions over 3 months.

The therapy focuses on 'gut-directed' techniques, teaching patients skills to control gut function, and incorporates lifestyle and psychological factors tailored to individual needs, enhancing its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gut-directed hypnotherapy: the Manchester approach for treatment of irritable bowel syndrome. Gonsalkorale, WM.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9889201/

Meditation and Yoga for Irritable Bowel Syndrome Effectiveness outcomes from these intervention nonrandomized studies included improved symptoms and functional performance, QOL, sleep quality, mental health, ...

2. journals.lww.com journals.lww.com/ajg/fulltext/9900/yoga_for_irritable_bowel_syndrome__a_systematic.1742.aspx

Yoga for Irritable Bowel Syndrome: A Systematic Review ... With uncertain evidence, yoga did not reduce the gastrointestinal severity of symptoms, anxiety, and depression or improve quality of life in patients with IBS.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36422517/

Meditation and Yoga for Irritable Bowel Syndrome Virtually delivered yoga is safe and feasible, and effective in reducing IBS symptoms. Based on the primary end point, the intervention was not superior to an ...

4. withpower.com withpower.com/trial/phase-irritable-bowel-syndrome-11-2020-ca4e4

Yoga & Meditation for Irritable Bowel Syndrome Yoga has been shown to significantly reduce bowel symptoms, IBS severity, and anxiety in patients with irritable bowel syndrome (IBS), based on a systematic ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05719246?term=Short%20Bowel%20Syndrome&aggFilters=status:rec&limit=100&rank=20

Standardized Yoga & Meditation Program for Stress ... The aim of this study is to measure the impact of a brief , at-home, 6-week twice per week Standardized Yoga & Meditation Program for Stress Reduction program ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02721836

Yoga for Patients With Irritable Bowel Syndrome Also called a data safety and monitoring board, or DSMB. Early Phase 1 ... Effect of Yoga in the Therapy of Irritable Bowel Syndrome: A Systematic Review.

7. journals.lww.com journals.lww.com/ajg/fulltext/2023/02000/meditation_and_yoga_for_irritable_bowel_syndrome_.27.aspx

Meditation and Yoga for Irritable Bowel Syndrome The MY-IBS study is the first to demonstrate the feasibility and safety of an 8-week virtual yoga program combined with the home-based practice for patients ...

8. cghjournal.org cghjournal.org/article/S1542-3565(16)30555-9/fulltext

Does Yoga Help Patients With Irritable Bowel Syndrome? Interestingly, a walking program was as effective initially as yoga, although the group assigned to the walking program was better than the yoga ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35618329/

Meditation and yoga for irritable bowel syndrome Introduction: When delivered in person, yoga has been shown to be effective in managing irritable bowel syndrome (IBS) symptoms. Research is ...