{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T14:01:40Z","timestamp":1784901700945,"version":"3.55.0"},"reference-count":52,"publisher":"MDPI AG","issue":"21","license":[{"start":{"date-parts":[[2023,10,24]],"date-time":"2023-10-24T00:00:00Z","timestamp":1698105600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Nutrients"],"abstract":"<jats:p>Background: Functional gastrointestinal disorders (FGIDs) are common, difficult-to-manage conditions. Probiotics are emerging as a dietary component that influence gastrointestinal (GI) health. We conducted a double-blinded randomised controlled trial of a proprietary strain of deactivated Bacillus subtilis (BG01-4\u2122) high in branched-chain fatty acids (BCFA) to treat self-reported FGID. Methods: Participants (n = 67) completed a four-week intervention of BG01-4\u2122 (n = 34) or placebo (n = 33). The Gastrointestinal Symptom Rating Scale (GSRS) served as the outcome measure, collected prior to, at two weeks, and at four weeks after completion of the intervention. Results: At four weeks, one of three primary outcomes, constipation in the experimental group, was improved by 33% compared to placebo (15%); both other primary outcomes, Total GSRS and diarrhoea, were significantly improved in both the experimental and placebo groups (32%\/26% and 20%\/22%, respectively). The pre-planned secondary outcome, indigestion, was improved at four weeks (32%) but compared to the placebo (21%) was not significant (p = 0.079). Exploratory analysis, however, revealed that clusters for constipation (18% improvement, p &lt; 0.001), indigestion (11% improvement, p = 0.04), and dyspepsia (10% improvement, p = 0.04) were significantly improved in the intervention group compared to the placebo. Conclusions: These initial findings suggest that in people with self-reported FGID, BG01-4\u2122 improves specific symptoms of constipation and related GI dysfunction. Longer-term confirmatory studies for this intervention are warranted. Trial registration: This study was registered prospectively (25 October 2021) at the Australian New Zealand Clinical Trials Registry (ACTRN12621001441808p).<\/jats:p>","DOI":"10.3390\/nu15214490","type":"journal-article","created":{"date-parts":[[2023,10,24]],"date-time":"2023-10-24T06:29:01Z","timestamp":1698128941000},"page":"4490","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Bacillus Subtilis (BG01-4TM) Improves Self-Reported Symptoms for Constipation, Indigestion, and Dyspepsia: A Phase 1\/2A Randomized Controlled Trial"],"prefix":"10.3390","volume":"15","author":[{"given":"Craig","family":"Patch","sequence":"first","affiliation":[{"name":"School Allied Health, Human Services and Sport, Melbourne 3086, Australia"},{"name":"Adepa Lifesciences, Melbourne 3000, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9264-9880","authenticated-orcid":false,"given":"Alan J.","family":"Pearce","sequence":"additional","affiliation":[{"name":"School Allied Health, Human Services and Sport, Melbourne 3086, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mek","family":"Cheng","sequence":"additional","affiliation":[{"name":"Adepa Lifesciences, Melbourne 3000, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ray","family":"Boyapati","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Monash Health, Melbourne 3977, Australia"},{"name":"Faculty of Medicine, Nursing and Health Science, Monash University, Melbourne 3800, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J. Thomas","family":"Brenna","sequence":"additional","affiliation":[{"name":"Adepa Lifesciences, Melbourne 3000, Australia"},{"name":"Division of Nutritional Sciences, Cornell University, Ithaca, NY 14853, USA"},{"name":"Dell Paediatric Research Institute, Department of Paediatrics, of Nutrition, and of Chemistry, University of Texas at Austin, Austin, TX 78712, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,10,24]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"121","DOI":"10.1111\/j.1365-2982.2008.01097.x","article-title":"Functional gastrointestinal disorders as a public health problem","volume":"20","author":"Talley","year":"2008","journal-title":"Neurogastroenterol. Motil."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"783","DOI":"10.1111\/j.1365-2982.2007.01001.x","article-title":"Introduction. 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