Regulatory Oversight and Safety of Probiotic Use

Venugopalan, Veena; Shriner, Kimberly; Wong-Beringer, Annie

doi:10.3201/eid1611.100574

Cited by 159 publications

(108 citation statements)

References 17 publications

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“…Since there is no regulatory body which has oversight of probiotics it requires the research community investigate this over the counter treatment. 45 Mislabeled products can significantly impact the interpretation of probiotic safety and efficacy. 29,30 Commonly used probiotic strains have also been documented to contain antibiotic resistance genes which could create a potential source for transfer of resistance to other members of the microbial flora.…”

Section: Discussionmentioning

confidence: 99%

Impact of probiotic supplements on microbiome diversity following antibiotic treatment of mice

2016

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Shifts in microbial populations of the intestinal tract have been associated with a multitude of nutritional, autoimmune, and infectious diseases. The limited diversity following antibiotic treatments creates a window for opportunistic pathogens, diarrhea, and inflammation as the microbiome repopulates. Depending on the antibiotics used, microbial diversity can take weeks to months to recover. To alleviate this loss of diversity in the intestinal microbiota, supplementation with probiotics has become increasingly popular. However, our understanding of the purported health benefits of these probiotic bacteria and their ability to shape the microbiome is significantly lacking. This study examined the impact of probiotics concurrent with antibiotic treatment or during the recovery phase following antibiotic treatment of mice. We found that probiotics did not appear to colonize the intestine themselves or shift the overall diversity of the intestinal microbiota. However, the probiotic supplementation did significantly change the types of bacteria which were present. In particular, during the recovery phase the probiotic caused a suppression of Enterobacteriaceae outgrowth (Shigella and Escherichia) while promoting a blooming of Firmicutes, particularly from the Anaerotruncus genus. These results indicate that probiotics have a significant capacity to remodel the microbiome of an individual recovering from antibiotic therapy.

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Section: Discussionmentioning

confidence: 99%

Impact of probiotic supplements on microbiome diversity following antibiotic treatment of mice

2016

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“…Probiotics are generally well tolerated and free of adverse effects although, theoretically, the introduction of live bacteria may carry the risk of introducing resistance genes and causing septicaemia. 37 A previous Cochrane review of probiotics as a treatment for presumed infectious diarrhoea included 23 studies with a total of 1917 participants and found that probiotics reduced the risk of diarrhoea at 3 days [relative risk (RR) 0.66, 95% confidence interval (CI) 0.55 to 0.77, random-effects model; 15 studies] and the mean duration of diarrhoea by 30.48 hours (95% CI 18.51 to 42.46 hours, random-effects model; 12 studies). 35 A Cochrane review of probiotics for the prevention and treatment of AAD 38 included 63 studies with a total of 11,811 participants and indicated a statistically significant association of probiotic administration with reduction in AAD [RR 0.58, 95% CI 0.50 to 0.68; p < 0.001; I 2 = 54%; (risk difference -0.07, 95% CI -0.10 to -0.05) (number needed to treat 13, 95% CI 10.3 to 19.1)] in trials reporting on the number of patients with AAD.…”

Section: Probiotics To Prevent Antibiotic-associated Diarrhoeamentioning

confidence: 99%

Probiotics for Antibiotic-Associated Diarrhoea (PAAD): a prospective observational study of antibiotic-associated diarrhoea (including Clostridium difficile-associated diarrhoea) in care homes

Hood

Nuttall

Gillespie

et al. 2014

Health Technology Assessment

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BackgroundAntibiotic prescribing rates in care homes are higher than in the general population. Antibiotics disrupt the normal gut flora, sometimes causing antibiotic-associated diarrhoea (AAD).Clostridium difficile(Hall and O’Toole 1935) Prévot 1938 is the most commonly identified cause of AAD. Little is known either about the frequency or type of antibiotics prescribed in care homes or about the incidence and aetiology of AAD in this setting.ObjectivesThe Probiotics for Antibiotic-Associated Diarrhoea (PAAD) study was designed as a two-stage study. PAAD stage 1 aimed to (1) prospectively describe antibiotic prescribing in care homes; (2) determine the incidence ofC. difficilecarriage and AAD (includingC. difficile-associated diarrhoea); and (3) to consider implementation challenges and establish the basis for a sample size estimation for a randomised controlled trial (RCT) of probiotic administration with antibiotics to prevent AAD in care homes. If justified by PAAD stage 1, the RCT would be implemented in PAAD stage 2. However, as a result of new evidence regarding the clinical effectiveness of probiotics on the incidence of AAD, a decision was taken not to proceed with PAAD stage 2.DesignPAAD stage 1 was a prospective observational cohort study in care homes in South Wales with up to 12 months’ follow-up for each resident.SettingRecruited care homes had management and owner’s agreement to participate and three or more staff willing to take responsibility for implementing the study.ParticipantsEleven care homes were recruited, but one withdrew before any residents were recruited. A total of 279 care home residents were recruited to the observational study and 19 withdrew, 16 (84%) because of moving to a non-participating care home.Main outcome measuresThe primary outcomes were the rate of antibiotic prescribing, incidence of AAD, defined as three or more loose stools (type 5–7 on the Bristol Stool Chart) in a 24-hour period, andC. difficilecarriage confirmed on stool culture.ResultsStool samples were obtained at study entry from 81% of participating residents. Over half of the samples contained antibiotic-resistant isolates, with Enterobacteriaceae resistant to ciprofloxacin in 47%. Residents were prescribed an average of 2.16 antibiotic prescriptions per year [95% confidence interval (CI) 1.90 to 2.46]. Antibiotics were less likely to be prescribed to residents from dual-registered homes. The incidence of AAD was 0.57 (95% CI 0.41 to 0.81) episodes per year among those residents who were prescribed antibiotics. AAD was more likely in residents who were prescribed co-amoxiclav than other antibiotics and in those residents who routinely used incontinence pads. AAD was less common in residents from residential homes.ConclusionsCare home residents, particularly in nursing homes, are frequently prescribed antibiotics and often experience AAD. Antibiotic resistance, including ciprofloxacin resistance, is common in Enterobacteriaceae isolated from the stool of care home residents. Co-amoxiclav is associated with greater risk of AAD than other commonly prescribed antibiotics.Trial registrationCurrent Controlled Trials ISRCTN 7954844.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 18, No. 63. See the NIHR Journals Library website for further project information.

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“…The Joint FAO/WHO Expert Consultation on Evaluation of Health and Nutritional Properties of Probiotic bacteria has developed and proposed guidelines for evaluating probiotic bacteria in food that could lead to the harmonization of regulations and standards of probiotic bacteria health claims [1,25]. The recommended guidelines included: 1) using a combination of phenotypic and genotypic tests to identify the genus and species of the probiotic strain, as clinical evidences suggested that the health benefits of probiotic bacteria may be strain specific, 2) in vitro testing to delineate the mechanism of the probiotic effect, and 3) substantiation of the clinical health benefit of probiotic agents with human trials.…”

Section: Fao/who Approachmentioning

confidence: 99%

“…Biological agents require premarket evaluation of the safety, purity and potency, as well as efficacy for approval by FDA, whereas, dietary supplements do not [25]. According to FDA, the determining factor as to whether a probiotic is a dietary supplement is whether it has been used as a food.…”

Section: United States Approachmentioning

confidence: 99%

“…Currently there are no functional foods are regulated or marketed in the USA, and this is partly because there is no internationally accepted definition of a functional food [24]. The International Food information Council has suggested that functional foods be defined as foods that provide health benefits beyond basic nutrition [24,25].…”

Section: United States Approachmentioning

confidence: 99%

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Probiotic Food Products Classes, Types, and Processing

Awaisheh¹

2012

Probiotics

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Regulatory Oversight and Safety of Probiotic Use

Abstract: Saccharomyces boulardii probiotics should be used with caution for management of Clostridium difficile infections in hospitalized patients.

Cited by 159 publications

References 17 publications

Impact of probiotic supplements on microbiome diversity following antibiotic treatment of mice

Impact of probiotic supplements on microbiome diversity following antibiotic treatment of mice

Probiotics for Antibiotic-Associated Diarrhoea (PAAD): a prospective observational study of antibiotic-associated diarrhoea (including Clostridium difficile-associated diarrhoea) in care homes

Probiotic Food Products Classes, Types, and Processing

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