NCT04315714.

Study name	Impact of a yoga intervention on chronic abdominal pain, and associations with the metagenome and metabolome in participants with IBS
Methods	Randomised trial (cross‐over assignment)
Participants	Inclusion criteria 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 mean abdominal pain over past 7 days ≥ 3 (for cases: on 0–10 scale) Willingness to participate in all study procedures Exclusion criteria 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 Helicobacter pylori infection, etc.) Severe comorbid pain or psychiatric condition requiring recent hospitalisation Pregnancy, or plans to become pregnant during study period Unwilling to participate in study procedures
Interventions	Experimental: IBS yoga intervention (delivered online/virtually via Zoom) 10 participants with IBS will be randomised to the 6‐week yoga intervention at beginning of trial, followed by 6‐week control condition (observation/active monitoring). Experimental: IBS wait‐list control 10 participants with IBS will be randomised to the 6‐week wait‐list control (observation/active monitoring) at beginning of trial, followed by 6‐week yoga intervention. Experimental: HC yoga Intervention (delivered online/virtually via Zoom) 10 participants serving as HC will be randomised to the 6‐week yoga intervention at beginning of trial, followed by 6‐week control condition (observation/active monitoring). Experimental: HC wait‐list control condition 10 participants serving as HC will be randomised to the 6‐week wait‐list control (observation/active monitoring) at beginning of trial, followed by the 6‐week yoga intervention.
Outcomes	Primary outcome Changes in abdominal pain (at 6 weeks) Secondary outcomes Baseline metagenomics Baseline Metabolomics Changes in metagenomics (at 6 weeks) Changes in metabolomics (at 6 weeks)
Starting date	March 2021
Contact information	Kristen R Weaver, PhD; 410‐706‐5119; kristen.weaver@umaryland.edu
Notes

HC: healthy control; IBS: irritable bowel syndrome; IBS‐QOL: Irritable Bowel Syndrome Quality of Life; IBS‐SSS: Irritable Bowel Syndrome Symptom Severity Score.