Yoga for Indigestion and Delayed Gastric Emptying

(FD-GP Trial)

Overseen By Jessica Kearney-Bryan, BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Celiac, IBD, GI obstruction, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether yoga can help individuals with functional dyspepsia (indigestion) and gastroparesis (slow stomach emptying). The study examines the feasibility and acceptance of a seated yoga program for those with these conditions. Participants will attend two one-hour yoga sessions and practice at home. It suits individuals diagnosed with these digestive issues by a doctor who have not recently practiced yoga or similar exercises. As an unphased trial, this study provides a unique opportunity to explore alternative therapies for digestive health.

Do I have to stop taking my current medications for the trial?

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

What prior data suggests that this yoga-based intervention is safe for patients with Functional Dyspepsia and/or Gastroparesis?

Research has shown that seated yoga can be safe for individuals with digestive problems. Some studies have adapted a seated yoga routine, initially designed for people with gastrointestinal (GI) cancer, to assist those with upper GI issues like indigestion and slow stomach emptying. These studies reported no major safety concerns or negative effects from the yoga sessions.

In one study, certain yoga poses improved stomach muscle activity, indicating a positive impact on digestion. Another study found that doctors specializing in digestive health generally consider yoga safe and beneficial, although they might not always recommend it due to limited scientific data. Overall, while more research is needed, current findings suggest that seated yoga is well-tolerated and poses no major safety risks for those with digestive conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using seated yoga for indigestion and delayed gastric emptying because it offers a non-drug alternative that focuses on relaxation and physical activity, which are often overlooked in standard treatments like prokinetic drugs and dietary changes. Unlike medication, which can have side effects, seated yoga is a gentle, holistic approach that can be tailored to individual needs and practiced at home. This method promotes not only digestive health but also overall well-being, potentially transforming how these conditions are managed by reducing reliance on medication.

What evidence suggests that seated yoga might be an effective treatment for indigestion and delayed gastric emptying?

Studies have shown that yoga can effectively reduce symptoms and severity in people with digestive issues like IBS (Irritable Bowel Syndrome). Research indicates that yoga is a safe and popular choice among many patients dealing with these conditions. It improves quality of life by addressing both the physical and mental health aspects related to digestive problems. Additionally, yoga helps reduce stress, which often affects digestive health. These benefits suggest that a yoga-based approach, such as the Seated Yoga Skills Training tested in this trial, might be helpful for conditions like Functional Dyspepsia and Gastroparesis, which are the focus of this study. ^{3 4 5 6 7}

Who Is on the Research Team?

Elyse Thakur, MD

Principal Investigator

Wake Forest University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Functional Dyspepsia or Gastroparesis diagnosed by a doctor. It's not for those who've practiced yoga or similar activities like tai chi in the past 6 months, have certain GI disorders, recent GI surgery, severe liver disease, active cancer (except some skin cancers), psychosis, high suicide risk, eating disorders, cognitive issues, or substance abuse.

Inclusion Criteria

I have been diagnosed with Functional Dyspepsia or Gastroparesis by a doctor.

Signed, written consent

Exclusion Criteria

A positive screen for the following: current psychotic symptoms, elevated suicide risk, active eating disorder, cognitive impairment, current harmful alcohol or substance use

Underwent a regular yoga or other mediative movement practice (tai chi or qi gong) in the past 6 months

I have a chronic GI or liver condition, but not skin cancer in remission.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

0 weeks

Treatment

Participants undergo two one-hour yoga sessions with home practice administered individually by a yoga interventionist in GI clinic

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Qualitative Assessment

30-minute semi-structured interview to gather perspectives on the intervention

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Seated Yoga Skills Training

Trial Overview The study tests if a seated yoga program is doable and acceptable for patients with indigestion and delayed gastric emptying due to Functional Dyspepsia and Gastroparesis. The goal is to see if this intervention can be integrated into their treatment routine.

How Is the Trial Designed?

Group I: Seated Yoga Intervention Experimental Treatment 1 Intervention

Two one-hour yoga sessions with home practice administered individually by a yoga interventionist in GI clinic

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12068461/

Exploring the Impact of Yoga Intervention on Psychological ... Recent studies reported a significant reduction in the severity and symptoms of IBS after the yoga practice (Ashtanga Yoga and Meditation) in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9915057/

Gastroenterologist and Patient Attitudes Toward Yoga as a ... Emerging research demonstrates yoga as a CAM is safe and effective in treating IBS (6). Yoga is the preferred CAM among 77% of IBS patients (7) ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S187638202300046X

Yoga use, physical and mental health, and quality of life in ... This study explored yoga use as a predictor of IBS-related quality of life (QoL) in relation to other physical and psychological factors.

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06732453/brain-gut-yoga-for-functional-dyspepsia-and-gastroparesis-fd-gp

Brain-Gut Yoga for Functional Dyspepsia and ... This research looks to adapt an existing seated yoga intervention, designed for patients with GI cancer, for testing in patients with disorders ...

5. researchgate.net researchgate.net/publication/394994980_Mind-Body_Connection_in_Digestive_Health_Reviewing_the_Yogic_Impact_of_Asana_and_Pranayama

(PDF) Mind-Body Connection in Digestive Health Clinical and experimental studies report improvements in IBS, GERD, and functional constipation, with benefits extending to stress reduction, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06732453

NCT06732453 | Brain-Gut Yoga for Functional Dyspepsia ... This research looks to adapt an existing seated yoga intervention, designed for patients with GI cancer, for testing in patients with disorders of the upper GI ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12510425/

Transient Effect of Specific Yogic Posture on Gastric Motility ... The findings demonstrate that the structured yoga intervention significantly improved gastric myoelectric activity – evident through increased ...