Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2020 Jul 17;6(7):e04467.
doi: 10.1016/j.heliyon.2020.e04467. eCollection 2020 Jul.

Global analysis of clinical trials with probiotics

Theresia M G Dronkers  1 , Arthur C Ouwehand  2 , Ger T Rijkers  1   3
Affiliations
Review

Global analysis of clinical trials with probiotics

Theresia M G Dronkers et al. Heliyon. .

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.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Lack of correlation between the number of participants in clinical studies on probiotics and duration of the study.
Figure 2
Figure 2
Figure 1. Development in the number of clinical trials over time (in ClinicalTrials.gov) on probiotics (blue line), prebiotics (orange line) or microbiota (grey line). The Y-axis shows the number of registered studies per calendar year.
See this image and copyright information in PMC

References

    1. de Angelis C., Drazen J.M., Frizelle F.A., Haug C., Hoey J., Horton R., Kotzin S., Laine C., Marusic A., Overbeke A.J., Schroeder T.V., Sox H.C., Van Der Weyden M.B. Clinical trial registration: a statement from the international committee of medical journal editors. N. Engl. J. Med. 2004;351:1250–1251. - PubMed
    1. Brassington I. The ethics of reporting all the results of clinical trials. Br. Med. Bull. 2017;121(1):19–29. - PubMed
    1. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies) Guidance on the scientific requirements for health claims related to the immune system, the gastrointestinal tract and defence against pathogenic microorganisms. EFSA J. 2016;14(1):4369. 2016. 23.
    1. FAO/WHO . 2002. Guidelines for the Evaluation of Probiotics in Food.https://www.who.int/foodsafety/fs_management/en/probiotic_guidelines.pdf
    1. Gibson G.R., Brummer R.J., Isolauri E., Lochs H., Morelli L., Ockhuizen T., Rowland I.R., Schrezenmeir J., Stanton C., Verbeke K. The design of probiotic studies to substantiate health claims. Gut Microb. 2011;2(5):299–305. - PubMed

LinkOut - more resources