Impact of a Yoga Intervention on Pain and Multiomics in Participants With IBS

NCT04315714 | Completed

• 2 other identifiers: HP-000898151P30NR016579-01
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to see if a six-week yoga program delivered online/virtually via Zoom, reduces abdominal pain in people with irritable bowel syndrome (IBS). This study also looks at whether the yoga program changes the composition of microorganisms in the gut and their metabolites, and compares the program in people with IBS versus healthy people (also known as "healthy controls" or "HC"). People in this study are randomized (like flipping a coin) to one of two conditions: half of the people attend the online/virtual private yoga program delivered via Zoom for the first six-weeks, and half of the people wait for six-weeks and then attend the online/virtual private yoga program for six-weeks. The hypothesis of this study is that the practice of yoga induces shifts in the gut microbiota and microbial-derived metabolites, which will correlate with diminished abdominal pain.

Conditions

Irritable Bowel Syndrome; Abdominal Pain

Keywords

Irritable bowel syndrome; IBS; Yoga; Microbiome; Abdominal pain; Metagenome; Metabolome

Outcome Measures

Primary Outcomes (1)

• Changes in Abdominal Pain

  To test the hypothesis that a 6-week yoga intervention, delivered online/virtually via Zoom, reduces abdominal pain among participants with IBS. Participants will be asked to rate their average level of abdominal pain over the past 7 days on a 0-10 scale, where 0 represents no pain, and 10 represents the worst imaginable pain.

  6 weeks

Secondary Outcomes (4)

• Baseline Metagenomics

  Baseline

• Baseline Metabolomics

  Baseline

• Changes in Metagenomics

  6 weeks

• Changes in Metabolomics

  6 weeks

Study Arms (4)

IBS Yoga Intervention (delivered online/virtually via Zoom)

EXPERIMENTAL

Ten participants with IBS will be randomized to the 6-week yoga intervention at the beginning of the trial, followed by the 6-week control condition (observation/active monitoring).

Other: Yoga Program

IBS Waitlist Control Condition

EXPERIMENTAL

Ten participants with IBS will be randomized to the 6-week waitlist control condition (observation/active monitoring) at the beginning of the trial, followed by the 6-week yoga intervention.

Other: Yoga Program

HC Yoga Intervention (delivered online/virtually via Zoom)

EXPERIMENTAL

Ten participants serving as HC will be randomized to the 6-week yoga intervention at the beginning of the trial, followed by the 6-week control condition (observation/active monitoring).

Other: Yoga Program

HC Waitlist Control Condition

EXPERIMENTAL

Ten participants serving as HC will be randomized to the 6-week waitlist control condition (observation/active monitoring) at the beginning of the trial, followed by the 6-week yoga intervention.

Other: Yoga Program

Interventions

Yoga Program OTHER

Six-week, twice weekly, 60-minute private yoga program (delivered online/virtually via Zoom).

HC Waitlist Control Condition; HC Yoga Intervention (delivered online/virtually via Zoom); IBS Waitlist Control Condition; IBS Yoga Intervention (delivered online/virtually via Zoom)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ability to read/write in English
• Access to smartphone/computer/email; Internet and camera access for online/virtual yoga sessions via Zoom
• Physical ability to engage in twice weekly yoga for 6 weeks (60 minutes each session), with physical clearance provided by current healthcare provider
• Diagnosis of IBS and IBS subtype (for cases), with documentation provided by current healthcare provider
• Self-report average, abdominal pain over past 7 days ≥ 3 (for cases: on 0-10 scale)
• Willingness to participate in all study procedures

You may not qualify if:

• Regular yoga practice (past 3 months)
• Recent antibiotic use (past 3 months)
• Consumption of a strict vegan/vegetarian diet
• Plan to initiate prebiotic/synbiotic/probiotic use during study period
• Any medical condition (cardiac, pulmonary, neurological, musculoskeletal, immunological etc.) that would preclude engagement in the yoga intervention
• Any organic gastrointestinal condition (inflammatory bowel disease: Crohn's disease, Ulcerative Colitis, active H. pylori infection, etc.)
• Severe comorbid pain or psychiatric condition requiring recent hospitalization
• Pregnancy, or plans to become pregnant during study period
• Unwilling to participate in study procedures

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Maryland, Baltimore, School of Nursing

Baltimore, Maryland, 21201, United States

Location

Related Publications (19)

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  PMID: 30046155 BACKGROUND

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• 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.

  PMID: 27112106 BACKGROUND

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MeSH Terms

Conditions

Irritable Bowel Syndrome; Abdominal Pain

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Kristen R Weaver, PhD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This will be a randomized, controlled trial crossover design, evaluating a yoga intervention, delivered online/virtually via Zoom, with a wait-list control condition for 6 weeks. Study participants will be crossed over to the alternative intervention for an additional 6 weeks, with total intervention time of 12 weeks. Twenty participants with irritable bowel syndrome (IBS) and 20 healthy controls (HC) will be recruited; 10 participants with IBS will be randomized to the yoga intervention at the beginning of the trial, and 10 participants with IBS randomized to the waitlist control condition. Likewise, 10 HC participants will be randomized to the yoga intervention at the beginning of the trial, and 10 HC will be randomized to the waitlist control condition.

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 19, 2020
• Study Start: March 4, 2021
• Primary Completion: August 24, 2021
• Study Completion: August 24, 2021
• Last Updated: September 2, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be shared one year after the project end date and stored indefinitely, unless the participant requests that their data be removed.
• Access Criteria: Requests to access data from BRICS are reviewed and approved by the NINR/BRICS Operations team. Steps to request access include reading and submitting a signed BRICS data use certification (DUC), and submitting an Informatics System Access Request (ISAR). Protecting data privacy, security and confidentiality are among expectations of the BRICS policy for requesting data access.

Locations

US (1)