When trying to back probiotics with data it can be tricky trying to stay on the right side of the disease end point line. For many supplements these boundaries are, or ought to be, clear to all. You can’t claim to treat cancer, for example, nor can you claim your blood sugar management product works so well that diabetes suffers don’t need their medications. But for gut health the boundary is less clear. What is a healthy gut? When does a consumer who is having gut discomfort cross the line into outright disease, such as Irritable Bowel Syndrome or Crohn’s Disease? What kind of effects that a probiotic might have can be called ‘beneficial?’ What kind of conditions can be addressed, such as intermittent traveler’s diarrhea or gut dysbiosis associated with antibiotic treatment, without crossing over the line by claiming in effect to have treated a disease?
Birgit Michelsen, chief technology officer of Danish probiotic supplier Bifodan, spoke with NutraIngredients-USA at the recent Probiota Americas event in San Francisco. Michelsen was part of a panel that looked at how to navigate the present regulatory currents.
Finding useful models
“It’s important when designing new studies that the endpoint be kept in mind when designing the study. We have to look at study populations that are no necessarily ‘patients,’ but people who are healthy. Or people who are out of balance, you can say, from a health perspective,”Michelsen said.
For example, IBS has a symptom set that is not unique to that particular set of people. According to the Mayo Clinic, the diagnostic criteria of IBS are:
- Abdominal pain or cramping
- A bloated feeling
- Diarrhea or constipation — sometimes alternating bouts of constipation and diarrhea
- Mucus in the stool.
“These are symptoms that can also be found in so-called health populations that have not been diagnosed with IBS,” Michelsen said. Having that overlap means IBS sufferers can serve as an extreme model, so to speak, for the effect of probiotics in healthy populations.
“So we can use IBS patients in studies, because there is a similarity when it comes to the symptom picture,” she said.
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