{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T19:02:58Z","timestamp":1765825378207,"version":"3.48.0"},"reference-count":33,"publisher":"BMJ","issue":"6","funder":[{"DOI":"10.13039\/501100001922","name":"Efficacy and Mechanism Evaluation Programme","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001922","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2019,2,22]]},"published-print":{"date-parts":[[2019,6]]},"abstract":"\n Introduction<\/jats:title>\n \n Care home residents are at increased risk of infections and antibiotic prescription. Reduced antibiotic use from fewer infections would improve quality of life. The\n P<\/jats:italic>\n robiotics to\n R<\/jats:italic>\n educe\n I<\/jats:italic>\n nfections i\n N C<\/jats:italic>\n ar\n E<\/jats:italic>\n home re\n S<\/jats:italic>\n ident\n S<\/jats:italic>\n (PRINCESS) trial aims to determine the efficacy and investigate mechanisms of daily probiotics on antibiotic use and incidence of infections in care home residents.\n <\/jats:p>\n <\/jats:sec>\n \n Methods and analysis<\/jats:title>\n \n PRINCESS is a double-blind, individually randomised, placebo-controlled trial that will assess the effect of a daily oral probiotic combination of\n Lactobacillus rhamnosus,<\/jats:italic>\n GG (LGG) and\n Bifidobacterium animalis<\/jats:italic>\n subsp.\n lactis<\/jats:italic>\n , BB-12 (BB-12) on cumulative antibiotic administration days (CAADs) (primary outcome) for infection in up to 330 care home residents aged \u226565 years over up to 12\u2009months. Secondary outcomes include:\n Infection:<\/jats:italic>\n Total number of days of antibiotic administration for each infection type (respiratory tract infection, urinary tract infection, gastrointestinal infection, unexplained fever and other); number, site, duration of infection; estimation of incidence and duration of diarrhoea and antibiotic-associated diarrhoea;\n Stool microbiology<\/jats:italic>\n :\n Clostridium difficile<\/jats:italic>\n infection; Gram-negative Enterobacteriaceae and vancomycin-resistant enterococci; LGG and BB-12.\n Oral microbiology: Candida<\/jats:italic>\n spp.\n Health and well-being:<\/jats:italic>\n Self and\/or proxy health-related quality of life EQ5D (5\u2009L); self-and\/or proxy-reported ICEpop CAPability measure for older people.\n Hospitalisations:<\/jats:italic>\n number and duration of all-cause hospital stays.\n Mortality:<\/jats:italic>\n deaths.\n Mechanistic immunology outcomes:<\/jats:italic>\n influenza vaccine efficacy (haemagglutination inhibition assay and antibody titres); full blood count and immune cell phenotypes, plasma cytokines and chemokines; cytokine and chemokine response in whole blood stimulated\n ex vivo<\/jats:italic>\n by toll-like receptor 2 and 4 agonists; monocyte and neutrophil phagocytosis of\n Escherichia coli<\/jats:italic>\n ; serum vitamin D.\n <\/jats:p>\n <\/jats:sec>\n \n Ethics and dissemination<\/jats:title>\n Ethics approval is from the Wales Research Ethics Committee 3. Findings will be disseminated through peer-reviewed journals and conferences; results will be of interest to patient and policy stakeholders.<\/jats:p>\n <\/jats:sec>\n \n Trial registration number<\/jats:title>\n \n ISRCTN16392920<\/jats:ext-link>\n ; Pre-results.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1136\/bmjopen-2018-027513","type":"journal-article","created":{"date-parts":[[2019,6,21]],"date-time":"2019-06-21T06:16:33Z","timestamp":1561097793000},"page":"e027513","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":11,"title":["Protocol for a double-blind placebo-controlled trial to evaluate the efficacy of probiotics in reducing antibiotics for infection in care home residents: the Probiotics to Reduce Infections iN CarE home reSidentS (PRINCESS) trial"],"prefix":"10.1136","volume":"9","clinical-trial-number":[{"clinical-trial-number":"isrctn16392920","registry":"10.18810\/isrctn","type":"preResults"}],"author":[{"given":"Eleri","family":"Owen-Jones","sequence":"first","affiliation":[{"name":"Centre for Trials Research, Cardiff University, Cardiff, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rachel","family":"Lowe","sequence":"additional","affiliation":[{"name":"Centre for Trials Research, Cardiff University, Cardiff, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark","family":"Lown","sequence":"additional","affiliation":[{"name":"Primary Care and Population Sciences, University of Southampton, Aldermoor Health Centre, Southampton, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Gillespie","sequence":"additional","affiliation":[{"name":"Centre for Trials Research, Cardiff University, Cardiff, 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