Data published in the journal Heliyon showed that there are 1,619 human clinical trials registered on ClinicalTrials.gov and the International Clinical Trials Registry Platform (ICTRP) of the World Health Organization, with 43% of those on ClinicalTrials.gov including healthy participants – significant greater than the average of 25% of all registered clinical trials that accept healthy volunteers.
The data also revealed that 33.6% of the trials registered on ClinicalTrials.gov were funded by industry, which is about the same as the percentage of all trials in the registry funded by industry (33.1%), but less than the 42% seen for clinical trials with biologicals.
The new paper was authored by Theresia Dronkers (University College Roosevelt, the Netherlands), Arthur Ouwehand (DuPont Nutrition and Biosciences), and Ger Rijkers (University College Roosevelt and St Elisabeth Hospital (the Netherlands).
“This is what people want to hear about”
“For those saying there are no clinical trials to support probiotics, have a seat,” said George Paraskevakos, executive director of the International Probiotics Association, which co-funded the analysis along with University College Roosevelt, Middelburg.
“We are always hearing reports there’s no science, so this paper addresses this misconception,” Paraskevakos told NutraIngredients-USA.
Paraskevakos told us that the paper has been in the works for two years, and now that there is a database from ClinicalTrials.gov and the WHO’s ICTRP this could then be expanded to other registries.
“This shows that so much has been done in such a short period of time. This is what people want to hear about.”
While the new paper does not assess the results of these studies (ie. if they produced beneficial results) this is being assessed as an evolution to the initial idea supported by the IPA, said Paraskevakos.
LGG and BB12
Dronkers, Ouwehand, and Rijkers found that Lactobacillus rhamnosus GG (LGG) was registered in 146 studies, making it the most studied strain. This was followed by Bifidobacterium animalis ssp. lactis BB12, which was registered in 55 studies.
The analysis also revealed a geographical split between the registries, with 56% of probiotic trials in ClinicalTrials.gov being registered in the USA or Europe. On the other hand, the ICTRP data showing a rapid expansion of probiotic clinical trials in Asia. Specifically, the largest increases were observed for China and Iran.
“While the registration of probiotic studies can be improved, they do not seem to be grossly different from the studies registered in general in terms of size, inclusion of children and elderly, and publication in the scientific literature,” wrote Dronkers, Ouwehand, and Rijkers.
“Current studies on gut microbiota (including fecal microbiota transplantation) can lead to the discovery of new bacterial strains with probiotic properties. Ongoing and planned studies are not restricted to gastrointestinal diseases but also target neurological and neurodegenerative diseases as well as autoimmune diseases,” they concluded.
July 2020, Volume 6, Issue 7, e04467, doi: 10.1016/j.heliyon.2020.e04467
“Global analysis of clinical trials with probiotics”
Authors: T.M.G. Dronkers, A.C. Ouwehand, G.T. Rijkers