An Evaluation of a Multi‐strain Probiotic Supplement on General Wellness in Healthy Adults: A Randomized, Double‐Blind, Dose‐Response Study

Although many species of bacteria have been evaluated and marketed as probiotics, little work has examined the dose‐response effects of probiotics on microbiota and host. A probiotic formulation, containing Lactobacillus helveticus R0052, Lactobacillus rhamnosus R0011, Lactobacillus casei R0215, Pediococcus acidilactici R1001, Bifidobacterium breve R0070, Bifidobacterium longum BB536, Lactobacillus plantarum R1012 and Lactobacillus lactis ssp. lactis R1058, is currently marketed in the U.S. at 5 billion colony forming units (CFU)/capsule and 25 billion CFU/capsule doses. To determine the effects of the two doses of the multi‐strain probiotic supplements on gastrointestinal function and general wellbeing, a six‐week, randomized, double‐blind, dose‐response study was conducted with 69 healthy adults (18–50 years old). Participants were randomly assigned to receive the probiotic mix at 5 billion CFU, 25 billion CFU, or placebo for four weeks. Daily questionnaires were used to assess gastrointestinal symptoms and general wellness, specifically gastrointestinal distress symptoms, ear‐nose‐throat symptoms, epidermal symptoms, psychological health, cephalic symptoms, emetic symptoms, diarrhea, constipation, fatigue, and hunger. Bristol Stool Form Scale (BSFS) was used as a proxy of transit time. In addition, the Gastrointestinal Symptoms Rating Scale (GSRS) was administered weekly to further evaluate gastrointestinal symptoms. General wellness and gastrointestinal symptoms were not affected by the consumption of the multi‐strain probiotic at doses of 5 or 25 billion CFU. In addition, BSFS analysis showed no significant change in relative transit time among treatments. No serious adverse events were reported. Therefore, the multi‐strain probiotic formulation is well tolerated by healthy adults at 5 billion and 25 billion CFU per day. Support or Funding Information Lallemand Health Solutions, Inc.