Carefully designed probiotic studies can provide good data while skirting disease endpoints, supplier says

Because supplements are not meant to diagnose, treat or cure any illness, studying their benefits has to be done with healthy populations.  This is especially difficult in the area of gut health, in which there are no biomarkers to speak of to use and where there is no agreement even on what a healthy gut should look like.

Amy Smith, PhD, senior manager of  regulatory and scientific affairs for DuPont Nutrition & Health said her company has found ways around the strictures to get valuable data on their HOWARU line of probiotic ingredients.

“What DSHEA did was unique in that it carved out a niche for supplements so that they could be separate from drugs.  That category allows specific claims to be made based upon substantiation based on studying a healthy population,” ​Smith told NutraIngredients-USA.

“The difficulty in study a healthy population is showing that there is a health benefit. So picking the right endpoints, picking the right population, those are all challenges we are faced with. At DuPont we have looked at stressed populations, healthy populations that are subjected to different things,”​ she said.

“We have completed a recent study on a population of healthy adults who are physically active who are challenged when stress was introduced into their lives because of intense physical activity.  The point of the study was to show the benefit of the HOWARU Protect strains in keeping that population healthy.  The ones who took the probiotic stayed healthy and didn’t get the respiratory infections like the others did,” ​Howard said.

Murky method of action​

Another confounding factor is the fact that while the beneficial effects of probiotics have long been known, are more is discovered about these organisms all the time, still no one really knows how they work.  Is it the metabolites they pump out as they digest materials in the gut?  Is it something in the structure of their cell walls? Is it the simple fact that they preferentially latch on to the epithelial layer, preventing bad organisms from taking up residence? A combination of these factors?

Smith admitted this confusion exists, but said the only way around it is to invest in strain-specific science.

“It is a gray area. What exactly does the organism do in the digestive tract to convey a benefit?  However we do know that there are organisms that convey a benefit and organisms that don’t. So the only way to really know what your strain provides is to study it and to have a clinical study that will show the benefit.”​