scholarly journals Probiotics to reduce antibiotic administration in care home residents aged 65 years and older: the PRINCESS RCT

2021 ◽  
Vol 8 (7) ◽  
pp. 1-128
Author(s):  
Christopher C Butler ◽  
Eleri Owen-Jones ◽  
Mandy Lau ◽  
David Gillespie ◽  
Mark Lown ◽  
...  

Background Care homes are an increasingly important sector of care. Care home residents are particularly vulnerable to infections and are often prescribed antibiotics, driving antibiotic resistance. Probiotics may be a cheap and safe way to reduce antibiotic use. Efficacy and possible mechanisms of action are yet to be rigorously evaluated in this group. Objective The objective was to evaluate efficacy and explore mechanisms of action of a daily oral probiotic combination in reducing antibiotic use and infections in care home residents. Design This was a multicentre, parallel, individually randomised, placebo-controlled, double-blind trial, with qualitative evaluation and mechanistic studies. Setting A total of 310 care home residents were randomised from 23 UK care homes (from December 2016 to May 2018). Participants The participants were care home residents aged ≥ 65 years who were willing and able to give informed consent or, if they lacked capacity to consent, had a consultee to advise about participation on their behalf. Intervention A daily capsule containing an oral probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp. lactis BB-12 (n = 155) or matched placebo (n = 155) for up to 1 year. Main outcome measures The primary outcome was cumulative systemic antibiotic administration days for all-cause infections. Secondary outcomes included incidence and duration of infections, antibiotic-associated diarrhoea, quality of life, hospitalisations and the detection of resistant Enterobacterales cultured from stool samples (not exclusively). Methods Participants were randomised (1 : 1) to receive capsules containing probiotic or matched placebo. Minimisation was implemented for recruiting care home and care home resident sex. Care home residents were followed up for 12 months with a review by a research nurse at 3 months and at 6–12 months post randomisation. Care home residents, consultees, care home staff and all members of the trial team, including assessors and statisticians, were blinded to group allocation. Results Care home residents who were randomised to probiotic had a mean 12.9 cumulative systemic antibiotic administration days (standard error 1.49 days) (n = 152) and care home residents randomised to placebo had a mean 12.0 cumulative systemic antibiotic administration days (standard error 1.50 days) (n = 153) (adjusted incidence rate ratio = 1.13, 95% confidence interval 0.79 to 1.63; p = 0.495). There was no evidence of any beneficial effects on incidence and duration of infections, antibiotic-associated diarrhoea, quality of life, hospitalisations, the detection of resistant Enterobacterales cultured from stool samples or other secondary outcomes. There was no evidence that this probiotic combination improved blood immune cell numbers, subtypes or responses to seasonal influenza vaccination. Conclusions Care home residents did not benefit from daily consumption of a combination of the probiotics Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp. lactis BB-12 to reduce antibiotic consumption. Limitations Limitations included the following: truncated follow-up of some participants; higher than expected probiotics in stool samples at baseline; fewer events than expected meant that study power may have been lower than anticipated; standard infection-related definitions were not used; and findings are not necessarily generalisable because effects may be strain specific and could vary according to patient population. Future work Future work could involve further rigorous efficacy, mechanisms and effectiveness trials of other probiotics in other population groups and settings regarding antibiotic use and susceptibility to and recovery from infections, in which potential harms should be carefully studied. Trial registration Current Controlled Trials ISRCTN16392920. Funding This project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a MRC and NIHR partnership. This will be published in full in Efficacy and Mechanism Evaluation; Vol. 8, No. 7. See the NIHR Journals Library website for further project information.

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e027513 ◽  
Author(s):  
Eleri Owen-Jones ◽  
Rachel Lowe ◽  
Mark Lown ◽  
David Gillespie ◽  
Katy Addison ◽  
...  

IntroductionCare home residents are at increased risk of infections and antibiotic prescription. Reduced antibiotic use from fewer infections would improve quality of life. TheProbiotics toReduceInfections iN CarEhome reSidentS(PRINCESS) trial aims to determine the efficacy and investigate mechanisms of daily probiotics on antibiotic use and incidence of infections in care home residents.Methods and analysisPRINCESS is a double-blind, individually randomised, placebo-controlled trial that will assess the effect of a daily oral probiotic combination ofLactobacillus rhamnosus,GG (LGG) andBifidobacterium animalissubsp.lactis, BB-12 (BB-12) on cumulative antibiotic administration days (CAADs) (primary outcome) for infection in up to 330 care home residents aged ≥65 years over up to 12 months. Secondary outcomes include:Infection: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;Stool microbiology:Clostridium difficileinfection; Gram-negative Enterobacteriaceae and vancomycin-resistant enterococci; LGG and BB-12.Oral microbiology: Candidaspp.Health and well-being:Self and/or proxy health-related quality of life EQ5D (5 L); self-and/or proxy-reported ICEpop CAPability measure for older people.Hospitalisations:number and duration of all-cause hospital stays.Mortality:deaths.Mechanistic immunology outcomes: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 stimulatedex vivoby toll-like receptor 2 and 4 agonists; monocyte and neutrophil phagocytosis ofEscherichia coli; serum vitamin D.Ethics and disseminationEthics 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.Trial registration numberISRCTN16392920; Pre-results.


2017 ◽  
Vol 8 (3) ◽  
pp. 345-351 ◽  
Author(s):  
K. Draper ◽  
C. Ley ◽  
J. Parsonnet

Probiotic use has skyrocketed in recent years. Little is known, however, about patient knowledge and practices regarding probiotic use, especially in the context of antibiotic use. An invitation to complete a short, anonymous, electronic survey was sent by email to 965 patients at a tertiary medical centre in California who had agreed to be contacted for participation in research studies. Questions were asked about both probiotic and antibiotic use in the prior three months. Of 333 survey respondents, 55% had recently used probiotics, including food products and/or supplements (90 and 60% of probiotic users, respectively). Women were more likely than men to have used probiotics (odds ratio (OR): 1.99; 95% confidence interval (CI): 1.2-3.4). Health care providers (HCP) had prescribed antibiotics to 79 (24%) respondents in the preceding three months. Among antibiotic users, 33% had initiated or changed probiotics at the time of antibiotic use, usually without a recommendation from their prescribing HCP (72%). Only 12% of those who took probiotics with antibiotics had received a specific recommendation from their HCP. Most patients chose to take probiotic mixtures (56%), with few selecting evidence-based strains, such as Lactobacillus rhamnosus GG (11%). Regular probiotic use among patients is common. Typically, these probiotics are not recommended by a HCP, even in conjunction with antibiotic prescriptions. While a growing body of evidence supports specific probiotic strains for the prevention of antibiotic-associated diarrhoea, patients are often not receiving a specific recommendation from their HCP and appear to be taking strains without guidance from supporting evidence.


Dermatology ◽  
2020 ◽  
pp. 1-7
Author(s):  
Ji-Hye Park ◽  
YoungHwan Choi ◽  
Hyun Je Kim ◽  
Se Jin Oh ◽  
Dong-Youn Lee ◽  
...  

<b><i>Background:</i></b> Acneiform eruption is the most common cutaneous adverse event associated with cetuximab. As it can affect quality of life and adversely affect chemotherapy schedule, additional medical care is required. <b><i>Objectives:</i></b> To investigate the adherence to and the duration of antibiotic administration to treat cetuximab-induced acneiform eruption. <b><i>Methods:</i></b> Medical data of patients who were referred to the Department of Dermatology were reviewed from January 2013 to June 2018. Dermatologists assessed the severity of acneiform eruption and prescribed tetracycline-class antibiotics according to the severity every 2 or 4 weeks. We investigated the duration and amount of oral antibiotic administration and analyzed the factors that may affect the control of acneiform eruption statistically. <b><i>Results:</i></b> A total of 207 of 267 patients referred to the Department of Dermatology showed acneiform eruption; 124 patients were treated with minocycline, 34 patients with doxycycline, 27 patients with both, and 22 patients with topical agents. The mean duration of oral antibiotic medication was 82.7 days. A statistical analysis of the factors that prolonged the use of antibiotics for more than 90 days showed that male and younger age were risk factors. Shorter time interval from starting cetuximab to starting antibiotics was associated with longer duration of antibiotic use, statistically. <b><i>Conclusions:</i></b> Cetuximab-induced acneiform eruption can be well controlled with tetracycline-class antibiotics in about 3 months. It can last longer in male and younger patients. The sooner and the more severe it appears, the longer it can last.


2000 ◽  
Vol 21 (6) ◽  
pp. 394-397 ◽  
Author(s):  
Raúl E. Istúriz ◽  
Claude Carbon

Antimicrobials have been used successfully for over 6 decades, but genes expressing resistance to them have emerged in strains of bacteria and have disseminated through the global ecosystem to reach infecting microorganisms, produce disease, and seriously interfere with therapy, allowing infections to progress and kill despite antibiotic administration. The upsurge in prevalence of such resistance genes in the bacterial population that colonize and infect humans involves two processes, emergence and dissemination, in both of which there have been contributions from the developing world, where resistance is common and increasing. The emergence of pneumococcal isolates noted in Papua New Guinea and later in South Africa that 1 decade later spread to most of the world and the intercontinental spread between the United States and Venezuela of a new gentamicin resistance gene carried on an epidemic plasmid are examples of the ability of bacteria to travel freely, without regard to borders. Complex societal issues such as the misuse of antibiotics by physicians, pharmacists, and the public; the suboptimal quality of the drugs (emergence); and conditions such as crowding, lack of hygiene, poor or nonexistent hospital infection control practices, or insufficient surveillance (dissemination) play a largely unmeasured role that requires study and solutions. In the meantime, we may intervene to delay the emergence of resistance and to limit its spread by promoting the judicious use of antibiotics both at the local level as well as from multinational organized cooperative efforts. Education and improvement of surveillance and socioeconomic conditions are integral parts of any solution strategy.


2012 ◽  
Vol 109 (11) ◽  
pp. 1999-2007 ◽  
Author(s):  
Tracey J. Smith ◽  
Diane Rigassio-Radler ◽  
Robert Denmark ◽  
Timothy Haley ◽  
Riva Touger-Decker

College students are susceptible to upper respiratory infections (URI) due to inadequate sleep, stress and close living quarters. Certain probiotic strains modulate immune function and may improve health-related quality of life (HRQL) during URI. The present study recruited apparently healthy college students and assessed the effect of probiotics on HRQL outcomes (i.e. self-reported duration, symptom severity and functional impairment of URI) in those who developed URI. Missed school and work days due to URI were also considered. Subjects (n 231) were apparently healthy college students living on campus in residence halls at the Framingham State University (Framingham, MA, USA), and were randomised to receive placebo (n 117) or probiotic-containing powder (daily dose of minimum 1 billion colony-forming units of each Lactobacillus rhamnosus LGG® (LGG®) and Bifidobacterium animalis ssp. lactis BB-12® (BB-12®); n 114) for 12 weeks. Subjects completed The Wisconsin Upper Respiratory Symptom Survey-21 to assess HRQL during URI. The final analyses included 198 subjects (placebo, n 97 and probiotics, n 101). The median duration of URI was significantly shorter by 2 d and median severity score was significantly lower by 34 % with probiotics v. placebo (P< 0·001), indicating a higher HRQL during URI. Number of missed work days was not different between groups (P= 0·429); however, the probiotics group missed significantly fewer school days (mean difference = 0·2 d) compared to the placebo group (P= 0·002). LGG® and BB-12® may be beneficial among college students with URI for mitigating decrements in HRQL. More research is warranted regarding mechanisms of action associated with these findings and the cost–benefit of prophylactic supplementation.


2018 ◽  
Vol 68 (suppl 1) ◽  
pp. bjgp18X696833 ◽  
Author(s):  
Leah Ffion Jones ◽  
Emily Cooper ◽  
Cliodna McNulty

BackgroundEscherichia coli bacteraemia rates are rising with highest rates in older adults. Mandatory surveillance identifies previous Urinary Tract Infections (UTI) and catheterisation as risk factors.AimTo help control bacteraemias in older frail patients by developing a patient leaflet around the prevention and self-care of UTIs informed by the Theoretical Domains Framework.MethodFocus groups or interviews were held with care home staff, residents and relatives, GP staff and an out of hours service, public panels and stakeholders. Questions explored diagnosis, management, prevention of UTIs and antibiotic use in older adults. The leaflet was modified iteratively. Discussions were transcribed and analysed using Nvivo.ResultsCarers of older adults reported their important role in identifying when older adults might have a UTI, as they usually flag symptoms to nurses or primary care providers. Information on UTIs needs to be presented so residents can follow; larger text and coloured sections were suggested. Carers were optimistic that the leaflet could impact on the way UTIs are managed. Older adults and relatives liked that it provided new information to them. Staff welcomed that diagnostic guidance for UTIs was being developed in parallel; promoting consistent messages. Participants welcomed and helped to word sections on describing asymptomatic bacteriuria simply, preventing UTIs, causes of confusion and when to contact a doctor or nurseConclusionA final UTI leaflet for older adults has been developed informed by the TDF. See the TARGET website www.RCGP.org.uk/targetantibiotics/


Author(s):  
Tommaso Cai ◽  
Luca Gallelli ◽  
Erika Cione ◽  
Gianpaolo Perletti ◽  
Francesco Ciarleglio ◽  
...  

Abstract Purpose To evaluate the efficacy of Lactobacillus paracasei CNCM I-1572 (L. casei DG®) in both prevention of symptomatic recurrences and improvement of quality of life in patients with chronic bacterial prostatitis (CBP). Methods Patients with CBP attending a single Urological Institution were enrolled in this phase IV study. At enrollment, all patients were treated with antibiotics in agreement with EAU guidelines and then were treated with L. casei DG® (2 capsules/day for 3 months). Clinical and microbiological analyses were carried out before (enrollment, T0) and 6 months (T2) after the treatment. Both safety and adherence to the treatment were evaluated 3 months (T1) after the enrollment. NIH Chronic Prostatitis Symptom Index (CPSI), International Prostate Symptom Score (IPSS) and Quality of Well-Being (QoL) questionnaires were used. The outcome measures were the rate of symptomatic recurrence, changes in questionnaire symptom scores and the reduction of antibiotic use. Results Eighty-four patients were included. At T2, 61 patients (72.6%) reported a clinical improvement of symptoms with a return to their clinical status before symptoms. A time dependent improvement in clinical symptoms with significant changes in NIH-CPSI, IPSS and QoL (mean difference T2 vs T0: 16.5 ± 3.58; − 11.0 ± 4.32; + 0.3 ± 0.09; p < 0.001), was reported. We recorded that L. casei DG® treatment induced a statistically significant decrease in both (p < 0.001) symptomatic recurrence [1.9/3 months vs 0.5/3 months] and antibiotic use [− 7938 UDD]. No clinically relevant adverse effects were reported. Conclusions L. casei DG® prevents symptomatic recurrences and improves the quality of life in patients with CBP, reducing the antibiotic use.


Author(s):  
Jan Schmidt ◽  
Martina Kunderova ◽  
Nela Pilbauerova ◽  
Martin Kapitan

This work provides a narrative review covering evidence-based recommendations for pericoronitis management (Part A) and a systematic review of antibiotic prescribing for pericoronitis from January 2000 to May 2021 (Part B). Part A presents the most recent, clinically significant, and evidence-based guidance for pericoronitis diagnosis and proper treatment recommending the local therapy over antibiotic prescribing, which should be reserved for severe conditions. The systematic review includes publications analyzing sets of patients treated for pericoronitis and questionnaires that identified dentists' therapeutic approaches to pericoronitis. Questionnaires among dentists revealed that almost 75% of them prescribed antibiotics for pericoronitis, and pericoronitis was among the top 4 in the frequency of antibiotic use within the surveyed diagnoses and situations. Studies involving patients showed that antibiotics were prescribed to more than half of the patients with pericoronitis, and pericoronitis was among the top 2 in the frequency of antibiotic use within the monitored diagnoses and situations. The most prescribed antibiotics for pericoronitis were amoxicillin and metronidazole. The systematic review results show abundant and unnecessary use of antibiotics for pericoronitis and are in strong contrast to evidence-based recommendations summarized in the narrative review. Adherence of dental professionals to the recommendations presented in this work can help rapidly reduce the duration of pericoronitis, prevent its complications, and reduce the use of antibiotics and thus reduce its impact on patients' quality of life, healthcare costs, and antimicrobial resistance development.


Animals ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. 590
Author(s):  
Glenise B. Voss ◽  
Vera Sousa ◽  
Paulo Rema ◽  
Manuela. E. Pintado ◽  
Luísa M. P. Valente

The apparent digestibility coefficients (ADCs) of differently processed okara meals were assessed in Nile tilapia diets: dried okara not autoclaved (FOK), dried okara autoclaved (AOK), okara hydrolyzed with Alcalase (ALOK) or Cynara cardunculus proteases (CYOK), and hydrolyzed okara fermented with lactic bacteria: Lactobacillus rhamnosus R11 (CYR11OK) or Bifidobacterium animalis ssp. lactis Bb12 (CYB12OK). Okara processing significantly affected nutrient digestibility: dry matter ADC was highest in CYR11OK (80%) and lowest in FOK (40%). The lowest protein digestibility was observed in CYR11OK (72%), and the highest in AOK (97%) and CYOK (91%), evidencing the effectiveness of the autoclave and the use of C. cardunculus proteases to increase okara protein bioavailability. The inclusion of up to 20% of AOK or CYOK did not affect fish growth, nutrient utilization, or whole body composition of Nile tilapia. The flesh quality (color, pH, water activity, cohesiveness, elasticity and resilience) was not affected by the dietary incorporation of AOK or CYOK. Fish fed with AOK diets stand out for their high density of muscle fibers, particularly in AOK20, which can explain their high muscle firmness and may result in further hypertrophic growth. Altogether, results suggest that hydrolyzed or autoclaved okara are valuable ingredients for Nile tilapia diets.


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