ABSTRACT
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.
ABSTRACT
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 ClincialTrials.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.
