imagesProbiotics are live microorganisms that, when taken as a supplement, can help establish a healthy balance of bacteria in the gut. For many, the word bacteria often carries a negative connotation; however, bacteria play a crucial role in maintaining normal GI function and protecting the body from infection. Although there is no evidence-based research to support the ability of probiotics to treat symptoms associated with celiac disease[1], many patients take probiotics believing in their ability to promote gut health. However, because probiotics are regulated as a dietary supplement and not a biological product, there is little, if any, requirement to validate for gluten purity or content before marketing the product[2]. As a result, although many supplements claim to be gluten-free, this is often not the case.

To test the validity of the gluten-free claim found on many probiotic supplements, Dr. Samantha Nazareth and her team from Columbia University purchased 22 of the most popular brands of probiotics and tested gluten composition. What they found is that 12 of the 22 contained a detectable level of gluten, and of these 12, eight were labeled gluten-free, with two exceeding the FDA gluten-free labeling standard[3]. A product must contain less than 20 parts per million (ppm) of gluten to be labeled gluten-free by the FDA. Although the majority of those tested were below this threshold, consumers should not be confident that the product is safe for consumption. It is also possible that the accumulation of gluten by taking multiple capsules of probiotic each day can cause harm to the consumer. In the future, there must be more stringent regulations in marketing the contents of probiotics to ensure the consumer is not inadvertently consuming gluten. As for the consumer, it is important to research supplements taken in order to know exactly what they contain.

pillCeliac Disease Foundation has taken steps to address this situation, demanding of both the FDA and the state attorney general more stringent regulations in labeling the contents of probiotics to ensure the consumer is not inadvertently consuming gluten. This is especially important in the long-run to CDF’s patient-powered research network (PPRN) for celiac disease, which will help patients contribute to research and engage in clinical trials. Beginning in fall of 2015, CDF will be collecting probiotic and other health-related information from PPRN participants to present to the FDA’s Center for Food Safety and Applied Nutrition (CSFAN). Funded by the Patient Centered Outcomes Research Institute, which was established by the Affordable Care Act, the PPRN will allow CDF constituents to actively improve and accelerate medical research and deepen researchers’ engagement with the celiac disease population.

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[1] Nazareth, S, Lebwohl, B, Tennyson, CA, Simpson, S, Greenlee, H, et al. “Dietary Supplement Use in Patients with Celiac Disease in the United States.” J Clin Gastroenterol. 2014 Sep 8.

[2] Boyle, Robert, Robins-Browne, Roy, Tang, Mimi. “Probiotic use in clinical practice: what are the risks?” The American Journal of Clinical Nutrition vol. 83 no. 6 1256-1264.

[3] Helwick, Caroline. “In Probiotics, ‘Gluten-Free’ Often a Misnomer.” Digestive Disease Week (DDW) 2015: Abstract 108. Presented May 16, 2015.