Digestive health has garnered significant attention among consumers as evidenced by the 2012 National Health Initiative Survey (NHIS) reporting approximately 4 million adults using dietary supplements aimed at enhancing digestive wellness. Probiotics which are beneficial bacteria and yeast primarily residing in the gastrointestinal tract are available as dietary supplements and are present in naturally occurring foods such as yogurt, kefir, sauerkraut, tempeh and kimchi. Previous research indicates improved digestive health, immune boosting and improved mental health, yet further investigation is warranted. This study aims to assess the impact of oral supplementation with a probiotic blend on gastrointestinal symptoms and alterations in microbiome composition.
BIOHM Health has been selling BIOHM FX, a blend of probiotics as a dietary supplement addressed at the digestive health market since 2017. The blend is present in the market in various concentrations ranging from 30 Billion colony forming units (CFU) to 1 Billion colony forming units (CFU). The probiotic blend consists of Lactobacillus acidophilus, Lactobacillus rhamnosus, Saccharomyces boulardii, Bifidobacterium breve and amylase. The blend is manufactured at Current Good Manufacturing Practice (cGMP) facilities located in the United States and has attained self Generally Recognized as Safe (GRAS) status. Prior to release, each lot of probiotic blend is tested for heavy metals, objectionable organisms, water content, probiotic potency, enzyme activity level and allergens, Soy, Milk and Gluten. Additionally, BIOHM performs annual testing for a full Food Allergen Labeling and Consumer Protection Act (FALCPA) panel of allergens ensuring there are no allergens present in the blend.
BIOHM FX has previously been studied to show a number of digestive health-related properties such as supporting healthy digestion, reduced bloating, flatulence, abdominal pain and constipation. Additionally BIOHM FX has been shown to break down polymicrobial biofilms, and support healthy candida levels.
The rationale for this study is to observe the effect of two different doses of a consumer-grade probiotic product called FX Probiotic Blend on digestive symptoms in individuals with moderate gastrointestinal discomfort. Additionally, the study aims to observe the effects of the probiotic product on anxiety and quality of life, as well as effects on gut microbiota via activities and technologies that can successfully and effectively be completed and utilized in a home setting. Because this product is currently available in the over the counter (OTC) market across the United States, a consumer-driven, decentralized observational clinical research study is therefore well-suited for examining the effects of this probiotic product in this population.
The study team will examine the outcomes in a broad age-range of adults who have chosen to try this product. The study will incorporate participant reported outcome questionnaires and surveys and at-home stool collection. There is no "doctor-patient" relationship as part of this research since the participant as a consumer is making the informed choice to take the product and take part in the observational process with self-reported measures and at-home sample collection. Findings from this study will contribute knowledge toward the dosing and formulation of the probiotic product and the design of future studies.
