Clinical studies supporting beneficial characteristics of microbes are mandatory for establishing relevant use of probiotics in target populations.
A new study investigated which clinical studies with probiotics have been registered and where, and if the design, characteristics and quality of the studies are comparable to the overall registrations in ClinicalTrials.gov. In addition, an analysis was made of the diseases and conditions that were investigated as well as a geographical comparison of registered probiotic trials between two major databases.
Global analysis of clinical trials with probiotics was published in Heliyon in July 2020. The article was co-funded by the IPA and co-written by IPA Scientific Committee Chair Arthur Ouwehand (of DuPont Nutrition and BioSciences) along with researchers Ger Rijkers (also on IPA’s Scientific Advisory Board) and Tessa Dronkers of University College Roosevelt in the Netherlands.
The analysis is an interesting read for industry and academia alike. The excerpted abstract is below. But be sure to read the entire article (open access) for a nuanced and detailed look at the process and results.
Over 1,000 clinical studies with probiotics, registered at ClinicalTrials.gov and/or the International Clinical Trials Registry Platform (ICTRP) of the World Health Organization, have addressed over 700 different diseases and conditions. The average size of a clinical trial with probiotics (74 participants) is comparable to the overall average of all studies in ClinicalTrials.gov. Lactobacillus rhamnosus GG (LGG) and Bifidobacterium animalis ssp. lactis BB12 are the probiotic strains studied most. The exact composition of the product which is used, including the dosage, is not always indicated in the registry. The majority of probiotics studies at ClinicalTrials.gov is registered in the USA or Europe (56%). The data from ICTRP show the rapid expansion of clinical studies with probiotics in Asia, notably Iran and China.