{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T01:48:28Z","timestamp":1790732908032,"version":"4.1.0"},"reference-count":16,"publisher":"Walter de Gruyter GmbH","issue":"1","license":[{"start":{"date-parts":[[2015,1,1]],"date-time":"2015-01-01T00:00:00Z","timestamp":1420070400000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["BM"],"published-print":{"date-parts":[[2015,1,1]]},"abstract":"<jats:p>A probiotic formulation of <jats:italic>Enterococcus faecium<\/jats:italic> R0026 and <jats:italic>Bacillus subtilis<\/jats:italic> R0179 has been evaluated in previous clinical trials. However, <jats:italic>B. subtilis<\/jats:italic> R0179 has not been evaluated as a single probiotic strain or in combination with other strains at doses higher than 0.1\u00d710<jats:sup>9<\/jats:sup> cfu. To establish oral dose-response tolerance and gastrointestinal (GI) viability of <jats:italic>B. subtilis<\/jats:italic> R0179, a randomised, double-blind, placebo-controlled trial in healthy adults (n=81; 18-50 years old) was conducted. Participants received <jats:italic>B. subtilis<\/jats:italic> R0179 at 0.1, 1.0 or 10\u00d710<jats:sup>9<\/jats:sup> cfu\/capsule\/day or placebo for four weeks. General wellness was assessed using a daily questionnaire evaluating GI, cephalic, ear-nose-throat, behavioural, emetic, and epidermal symptoms. GI symptoms were further evaluated using a weekly gastrointestinal symptom rating scale (GSRS). GI transit viability of <jats:italic>B. subtilis<\/jats:italic> R0179 was assessed by plating and microbiota analysis by 16S rRNA at baseline, week 4 of the intervention and washout. General wellness and GI function were not affected by oral consumption of <jats:italic>B. subtilis<\/jats:italic> R0179 at any dose. Daily questionnaire syndrome scores were not different from baseline and did not exceed a clinically significant score of 1. GSRS syndrome scores were not different from baseline and ranged from 1.1\u00b10.1 to 1.9\u00b10.2. Faecal viable counts of <jats:italic>B. subtilis<\/jats:italic> R0179 demonstrated a dose response: the placebo group (1.1\u00b10.1 log<jats:sub>10<\/jats:sub> cfu\/g) differed from 0.1\u00d710<jats:sup>9<\/jats:sup> (4.6\u00b10.1 log<jats:sub>10<\/jats:sub> cfu\/g), 1\u00d710<jats:sup>9<\/jats:sup> (5.6\u00b10.1 log<jats:sub>10<\/jats:sub> cfu\/g) and 10\u00d710<jats:sup>9<\/jats:sup> (6.4\u00b10.1 log<jats:sub>10<\/jats:sub> cfu\/g) (<jats:italic>P<\/jats:italic>&lt;0.0001). No significant changes in phyla were observed, but sequence reads binned to multiple operational taxonomic units matching closest to <jats:italic>Ruminococci<\/jats:italic> increased during probiotic supplementation. <jats:italic>B. subtilis<\/jats:italic> R0179 survives passage through the human GI tract and is well tolerated by healthy adults at intakes from 0.1 to 10\u00d710<jats:sup>9<\/jats:sup> cfu\/day. The trial has been registered at www.clinicaltrials.gov under NCT01802151.<\/jats:p>","DOI":"10.3920\/bm2014.0031","type":"journal-article","created":{"date-parts":[[2014,7,26]],"date-time":"2014-07-26T01:23:47Z","timestamp":1406337827000},"page":"19-28","source":"Crossref","is-referenced-by-count":60,"title":["Evaluation of Bacillus subtilis R0179 on gastrointestinal viability and general wellness: a randomised, double-blind, placebo-controlled trial in healthy adults"],"prefix":"10.1163","volume":"6","author":[{"given":"A.","family":"Hanifi","sequence":"first","affiliation":[{"name":"Department of Food Science and Human Nutrition, University of Florida, 359 Newell Drive, Gainesville, FL 32611, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T.","family":"Culpepper","sequence":"additional","affiliation":[{"name":"Department of Epidemiology and Emerging Pathogens Institute, University of Florida, P.O. Box 100009, 2055 Mowry Road, Gainesville, FL 32610, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"V.","family":"Mai","sequence":"additional","affiliation":[{"name":"Department of Epidemiology and Emerging Pathogens Institute, University of Florida, P.O. Box 100009, 2055 Mowry Road, Gainesville, FL 32610, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Anand","sequence":"additional","affiliation":[{"name":"Department of Epidemiology and Emerging Pathogens Institute, University of Florida, P.O. Box 100009, 2055 Mowry Road, Gainesville, FL 32610, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.L.","family":"Ford","sequence":"additional","affiliation":[{"name":"Department of Food Science and Human Nutrition, University of Florida, 359 Newell Drive, Gainesville, FL 32611, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Ukhanova","sequence":"additional","affiliation":[{"name":"Department of Epidemiology and Emerging Pathogens Institute, University of Florida, P.O. Box 100009, 2055 Mowry Road, Gainesville, FL 32610, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Christman","sequence":"additional","affiliation":[{"name":"MCC Statistical Consulting LLC, 2219 NW 23rd Ter., Gainesville, FL 32605, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T.A.","family":"Tompkins","sequence":"additional","affiliation":[{"name":"Lallemand Health Solutions, Inc., 6100 Avenue Royalmount, Montreal, H4P 2R2 Quebec, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"W.J.","family":"Dahl","sequence":"additional","affiliation":[{"name":"Department of Food Science and Human Nutrition, University of Florida, 359 Newell Drive, Gainesville, FL 32611, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","reference":[{"key":"atypb1","doi-asserted-by":"publisher","DOI":"10.1123\/jpah.6.6.790"},{"key":"atypb2","doi-asserted-by":"publisher","DOI":"10.1038\/nmeth.f.303"},{"key":"atypb3","doi-asserted-by":"publisher","DOI":"10.1128\/AEM.68.5.2344-2352.2002"},{"key":"atypb4","first-page":"2857","volume":"23","journal-title":"China Pharmacy"},{"key":"atypb5","doi-asserted-by":"publisher","DOI":"10.1093\/nar\/gkn879"},{"key":"atypb6","doi-asserted-by":"publisher","DOI":"10.1016\/j.fm.2010.03.007"},{"key":"atypb7","first-page":"681","volume":"28","journal-title":"An improved evaluation of treatment regimens? 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