‘For those saying there are no clinical trials to support probiotics, have a seat’ – IPA Chief

By Stephen Daniells contact

- Last updated on GMT

© newannyart / Getty Images
© newannyart / Getty Images

Related tags: Probiotics, Clinical trials, Prebiotics, International probiotics association

There are over 1,600 human clinical trials on probiotics listed in ClinicalTrials.gov and the WHO’s trial database, according to a new analysis that seeks to address the misconception that there is no human data around probiotics.

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.

Prebiotics © Getty Images newannyart
The paper in Heliyon also reported that approximately 50 clinical studies with prebiotics are registered per year, and this is slowly increasing. Image: © newannyart / Getty Images

VSL#3 (a combination of Streptococcus thermophilus​ DSM24731, Lactobacillus acidophilus​ DSM24735, L. delbrueckii​ ssp. bulgaricus​ DSM24734, L. paracasei​ DSM24733, L. plantarum​DSM24730, Bifidobacterium longum​ DSM24736, B. infantis​ DSM24737, and B. breve​ DSM24732) was the most registered multi-strain product (registered in 74 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.

Source: Heliyon
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

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