Global analysis of clinical trials with probiotics

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

doi:10.1016/j.heliyon.2020.e04467

Global analysis of clinical trials with probiotics

Heliyon. 2020 Jul 17;6(7):e04467. doi: 10.1016/j.heliyon.2020.e04467. eCollection 2020 Jul.

Authors

Theresia M G Dronkers¹, Arthur C Ouwehand², Ger T Rijkers^{1

3}

Affiliations

¹ Department of Sciences, University College Roosevelt, Lange Noordstraat 1, 4331 CB, Middelburg, the Netherlands.
² DuPont Nutrition and Biosciences, Danisco Sweeteners Oy, Sokeritehtaantie, Kantvik, 02460, Finland.
³ Laboratory for Medical Microbiology and Immunology, St Elisabeth Hospital, Tilburg, the Netherlands.

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.

Keywords: Bacteria; Clinical trials; Digestive system; Immune system; Immunology; Microbiota; Microorganism; Prebiotics; Probiotics.

Publication types

Review