Global analysis of clinical trials with probiotics

Dronkers, Theresia M.G.; Ouwehand, Arthur C.; Rijkers, Ger T.

doi:10.1016/j.heliyon.2020.e04467

Cited by 72 publications

(57 citation statements)

References 14 publications

(15 reference statements)

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“…This Bifidobacterium belongs to a diverse group of B. animalis subsp. lactis isolated from different host species [ 55 ] and is one of the most frequently used probiotic bacteria in humans [ 56 ]. In our former experiments, we verified the safety of L. rhamnosus GG and E. coli Nissle 1917 for the gnotobiotic piglets and compared their protective effect against infection with S .…”

Section: Discussionmentioning

confidence: 99%

“…Thus, the presented work completes verification of the safety and efficacy of a triumvirate of well-known and broadly used probiotics Lactobacillus rhamnosus GG, E. coli Nissle 1917, and B. animalis subsp. lactis BB-12 [ 56 , 57 ] in the gnotobiotic piglet. In this case, we used commonly available probiotic BB12 that was isolated from a commercial preparation.…”

Section: Discussionmentioning

confidence: 99%

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Monoassociation of Preterm Germ-Free Piglets with Bifidobacterium animalis Subsp. lactis BB-12 and Its Impact on Infection with Salmonella Typhimurium

et al. 2021

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Preterm germ-free piglets were monoassociated with probiotic Bifidobacterium animalis subsp. lactis BB-12 (BB12) to verify its safety and to investigate possible protection against subsequent infection with Salmonella Typhimurium strain LT2 (LT2). Clinical signs of salmonellosis, bacterial colonization in the intestine, bacterial translocation to mesenteric lymph nodes (MLN), blood, liver, spleen, and lungs, histopathological changes in the ileum, claudin-1 and occludin mRNA expression in the ileum and colon, intestinal and plasma concentrations of IL-8, TNF-α, and IL-10 were evaluated. Both BB12 and LT2 colonized the intestine of the monoassociated piglets. BB12 did not translocate in the BB12-monoassociated piglets. BB12 was detected in some cases in the MLN of piglets, consequently infected with LT2, but reduced LT2 counts in the ileum and liver of these piglets. LT2 damaged the luminal structure of the ileum, but a previous association with BB12 mildly alleviated these changes. LT2 infection upregulated claudin-1 mRNA in the ileum and colon and downregulated occludin mRNA in the colon. Infection with LT2 increased levels of IL-8, TNF-α, and IL-10 in the intestine and plasma, and BB12 mildly downregulated them compared to LT2 alone. Despite reductions in bacterial translocation and inflammatory cytokines, clinical signs of LT2 infection were not significantly affected by the probiotic BB12. Thus, we hypothesize that multistrain bacterial colonization of preterm gnotobiotic piglets may be needed to enhance the protective effect against the infection with S. Typhimurium LT2.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Monoassociation of Preterm Germ-Free Piglets with Bifidobacterium animalis Subsp. lactis BB-12 and Its Impact on Infection with Salmonella Typhimurium

et al. 2021

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“…The median number of participants included in a clinical trial with probiotics is 74, which is not significantly different from that of 71 participants in all clinical studies registered at ClinicalTrials.gov [1] . Fig.…”

Section: Data Descriptionmentioning

confidence: 85%

“… The data on clinical trials with probiotics are important to gain more insight into registration procedures, the clinical conditions addressed, as well as the major characteristics, including size of the study (number of participants), and duration of the study [ 1 , 2 ]. Both (clinical) researchers as well as producers of probiotics can benefit from these data [ 3 , 4 , 5 ].…”

Section: Value Of the Datamentioning

confidence: 99%

Data on global analysis of clinical trials with probiotics

2020

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Data on characteristics of clinical trials with probiotics, registered at ClinicalTrials.gov were retrieved from the registry . Data on the registration process itself (moment of registration of the trial in relation to date of inclusion of first participant, data of completion of the study) as well as the number of participants were analysed. A trend analysis (over the period 2000-2020) was made of the number of participants in clinical trials with probiotics on gastrointestinal conditions and diseases. A comparison was made between conditions and diseases studied in completed clinical trials with those trials not yet recruiting participants. The data can be used and reused for assessment of the quality of clinical studies with probiotics and to identify future trends in applications of probiotics.

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“…For a microbial strain or a combination there of to be considered probiotic, it must have shown its effect in a human intervention trial. Randomised, double-blind, placebo-controlled and registered human clinical trials are at the core of probiotic innovation and ensure reliable and transparent research (Dronkers, Ouwehand and Rijkers 2020 ).…”

Section: Clinical Researchmentioning

confidence: 99%

Probiotic triangle of success; strain production, clinical studies and product development

Forssten

Laitila

Maukonen

et al. 2020

FEMS Microbiology Letters

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The successful development of probiotic foods and dietary supplements rests on three pillars; each with their specific challenges and opportunities. First, strain production; this depends on selecting the right strain with promising technological properties and safety profile. Further the manufacturing of the strain in a stable format at sufficiently high yield, following regulatory and customer requirements on culture media ingredients and other processing aids. The second pillar are the preclinical and clinical studies to document that the strain is a probiotic and exerts a health benefit on the host, the consumer. Especially when aiming for a regulator approved health claim, clinical studies need to be thoroughly performed; following appropriate ethical, scientific and regulatory guidelines. Finally, the probiotic will need to be incorporated in a product that can be brought to the consumer; a dietary supplement or a functional food. Because of the live nature of probiotics, specific challenges may need to be dealt with. Although experience from other strains is helpful in the process, the development is strain specific. Commercialisation and marketing of probiotics are strictly but differently regulated in most jurisdictions; defining what can and cannot be claimed.

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Global analysis of clinical trials with probiotics

Cited by 72 publications

References 14 publications

Monoassociation of Preterm Germ-Free Piglets with Bifidobacterium animalis Subsp. lactis BB-12 and Its Impact on Infection with Salmonella Typhimurium

Monoassociation of Preterm Germ-Free Piglets with Bifidobacterium animalis Subsp. lactis BB-12 and Its Impact on Infection with Salmonella Typhimurium

Data on global analysis of clinical trials with probiotics

Probiotic triangle of success; strain production, clinical studies and product development

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