The effect of a probiotic blend on gastrointestinal symptoms in constipated patients: A double blind, randomised, placebo controlled 2-week trial

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dc.contributor.author Airaksinen, K.
dc.contributor.author Yeung, N.
dc.contributor.author Lyra, A.
dc.contributor.author Lahtinen, S.J.
dc.contributor.author Huttunen, T.
dc.contributor.author Shanahan, Fergus
dc.contributor.author Ouwehand, A.C.
dc.date.accessioned 2019-11-20T05:36:40Z
dc.date.available 2019-11-20T05:36:40Z
dc.date.issued 2019-05-27
dc.identifier.citation Airaksinen, K., Yeung, N., Lyra, A., Lahtinen, S.J., Huttunen, T., Shanahan, F. and Ouwehand, A.C. (2019) 'The effect of a probiotic blend on gastrointestinal symptoms in constipated patients: a double blind, randomised, placebo controlled 2-week trial'. Beneficial microbes, 10(6), pp.617-627. doi:10.3920/BM2018.0163 en
dc.identifier.volume 10 en
dc.identifier.issued 6 en
dc.identifier.startpage 617 en
dc.identifier.endpage 627 en
dc.identifier.issn 1876-2883
dc.identifier.uri http://hdl.handle.net/10468/9131
dc.identifier.doi 10.3920/BM2018.0163 en
dc.description.abstract Selected strains of lactobacilli and bifidobacteria are known to ameliorate constipation-related symptoms and have previously shown efficacy on digestive health. In this clinical trial, the safety and effectiveness of a probiotic blend containing lactobacilli and bifidobacteria were evaluated in adults with self-reported bloating and functional constipation. Constipation was diagnosed by the Rome III criteria. A total of 156 adults were randomised into this double-blind and placebo-controlled trial. Participants consumed the combination of Lactobacillus acidophilus NCFM (1010 cfu), Lactobacillus paracasei Lpc-37 (2.5×109 cfu), Bifidobacterium animalis subsp. lactis strains Bl-04 (2.5×109 cfu), Bi-07 (2.5×109 cfu) and HN019 (1010 cfu) (n=78), or placebo (microcrystalline cellulose) (n=78) for two weeks. After treatment the following were measured: primary outcome of bloating and secondary outcomes of colonic transit time, bowel movement frequency, stool consistency, other gastrointestinal symptoms (flatulence, abdominal pain, and burbling), constipation-related questionnaires (PAC-SYM and PAC-QoL) and product satisfaction. Faecal recovery of consumed strains was determined. The enrolled population was defined as constipated, however, the initial bloating severity was lower than in previous similar studies. No clinically significant observations related to the safety of the product were reported. Product efficacy was not shown in the primary analysis for bloating nor for the secondary efficacy analyses. The placebo functioned similarly as the probiotic product. In post-hoc analysis, a statistically significant decrease in flatulence in favour of the probiotic group was observed; day 7 (intention-to-treat (ITT): P=0.0313; per-protocol (PP): 0.0253) and on day 14 (ITT: P=0.0116; PP: P=0.0102) as measured by area under the curve (AUC) analysis. The mean AUC of all symptoms decreased in favour of the probiotic group, indicating less digestive discomfort. The study was registered at the ISRCTN registry (ISRCTN41607808). en
dc.format.mimetype application/pdf en
dc.language.iso en en
dc.publisher Wageningen Academic Publishers en
dc.relation.uri https://www.wageningenacademic.com/doi/10.3920/BM2018.0163
dc.rights © 2019 Wageningen Academic Publishers en
dc.rights.uri https://creativecommons.org/licenses/by-nc-sa/4.0/ en
dc.subject Bifidobacteria en
dc.subject CTT en
dc.subject Flatulence en
dc.subject Lactobacilli en
dc.subject Transit en
dc.title The effect of a probiotic blend on gastrointestinal symptoms in constipated patients: A double blind, randomised, placebo controlled 2-week trial en
dc.type Article (peer-reviewed) en
dc.internal.authorcontactother Fergus Shanahan, APC Microbiome Ireland, University College Cork, Cork, Ireland. +353-21-490-3000 Email: f.shanahan@ucc.ie en
dc.internal.availability Full text available en
dc.description.version Published Version en
dc.contributor.funder Clorox Company en
dc.description.status Peer reviewed en
dc.identifier.journaltitle Beneficial Microbes en
dc.internal.IRISemailaddress f.shanahan@ucc.ie en
dc.identifier.eissn 1876-2891


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