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.authorAiraksinen, K.
dc.contributor.authorYeung, N.
dc.contributor.authorLyra, A.
dc.contributor.authorLahtinen, S.J.
dc.contributor.authorHuttunen, T.
dc.contributor.authorShanahan, Fergus
dc.contributor.authorOuwehand, Arthur C.
dc.contributor.funderClorox Companyen
dc.date.accessioned2019-11-20T05:36:40Z
dc.date.available2019-11-20T05:36:40Z
dc.date.issued2019-05-27
dc.description.abstractSelected 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.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.citationAiraksinen, 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/BM2018.0163en
dc.identifier.doi10.3920/BM2018.0163en
dc.identifier.eissn1876-2891
dc.identifier.endpage627en
dc.identifier.issn1876-2883
dc.identifier.issued6en
dc.identifier.journaltitleBeneficial Microbesen
dc.identifier.startpage617en
dc.identifier.urihttps://hdl.handle.net/10468/9131
dc.identifier.volume10en
dc.language.isoenen
dc.publisherWageningen Academic Publishersen
dc.relation.urihttps://www.wageningenacademic.com/doi/10.3920/BM2018.0163
dc.rights© 2019 Wageningen Academic Publishersen
dc.rights.urihttps://creativecommons.org/licenses/by-nc-sa/4.0/en
dc.subjectBifidobacteriaen
dc.subjectCTTen
dc.subjectFlatulenceen
dc.subjectLactobacillien
dc.subjectTransiten
dc.titleThe effect of a probiotic blend on gastrointestinal symptoms in constipated patients: A double blind, randomised, placebo controlled 2-week trialen
dc.typeArticle (peer-reviewed)en
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