More validation, standardisation, and mechanism of action studies needed to address gaps in probiotics research

These were the key findings of an expert panel convened at our recent Probiota Asia Summit held in Singapore, and moderated by NutraIngredients-Asia​ editor Tingmin Koe on what needs to be done to address them.

Panelist Dr Christopher Martoni, principal scientist at UAS Labs, said high-quality clinical trials were essential for the sector to thrive.

“RCT is the gold standard for clinical research​,” he said.

Another panelist, Dr Chyn Boon Wong, research associate at Morinaga Milk Industry, added that the number of subjects and “whether the study is well powered are also very critical criteria for clinical research​.”

Meanwhile Nutrasource’s Joshua Baisley, vice president of clinical design and delivery, added: “Documentation and validation of your data is also very important. These should be filed right at the start, and not afterwards​.”

Current gaps​

The panelists jointly agreed there were gaps in the current probiotics research, especially on the mechanism of action.

Martoni said there was a need to continue to invest in RCTs with robust study designs. “The key gap here is in the mechanism of action, we need to understand where the probiotics are acting, where the target sites are​.”

Some clinical trials were also lacking in information on both responders and non-responders, according to Martoni, who called for more information on efficacy.

Wong added: “The mechanism of action is one thing that we have been neglecting. I agree it is very important to understand the science behind the probiotic strains, especially how it works and what interactions they have​.”

She said advanced technology like metabolomics may help better understand these strains and the effects seen in clinical efficacy.

“Through technology,​ we can study the types of metabolites being produced that can act as mediators in the gut, and communicate with the gut microbiome​,” she added.

Wong said learning how to modulate the gut, and mediate or eliminate hyperinflammatory responses in the gut, could eventually help understand many diseases and disorders.

Baisley pointed out that another area that could be improved was within the industry itself, where many sponsors were running clinical trials as a one-off study.

This creates a gap in terms of the validation of clinical data management and an inability to pull data together, even though studies often work on the same strain or genus.

“It is very difficult because we are all collecting data in different ways. There needs to be some sort of standardisation,” ​he said.

Regulators criteria​

Koe posed a question to the panelists on what regulators were looking out for given that there were different standards in probiotic research and different budget expectations.

Baisley answered that regulators were comfortable with the pharmaceutical industry which required pre-clinical research, and this created challenges for the probiotic and dietary supplement industry.

“We see now in APAC, regulators want to see studies conducted in their geographic population,” ​he said.

He added that the ICH-GCP (International Council for Harmonization-Good Clinical Practice) is an important criterion that regulators would take note.

Even though it was set up as a pharmaceutical guideline, Baisley said “The criteria in there is not pharmaceutical, it’s best practices and protocol. It’s about how you design your studies, what you need to include in your protocol, how to ensure people can execute your study etc​.”