(P19-044-25) Bacillus Coagulans Unique IS2 Improves Stool Characteristics In Healthy Adults With Infrequent Bowel Movements: A Randomized, Double-Blind, Placebo-Controlled Trial

Objectives: Over 60 million Americans are affected by digestive conditions and diseases leading to decreased quality of life and increased risk of various diseases. Most research examining probiotic efficacy has been conducted in specific patient populations, rather than a generally healthy population. Specifically, Bacillus coagulans Unique IS2 (Unique IS2) has improved stool frequency, stool consistency, and gastrointestinal (GI) symptoms in participants with constipation, irritable bowel syndrome (IBS), or diarrhea. Therefore, this randomized, double-blind, placebo-controlled trial investigated the efficacy of Unique IS2 on stool characteristics and GI symptoms in generally healthy adults.

Methods: Following a 2-week run-in, 144 healthy adults (18-65 years; BMI: 18.5-34.9 kg/m2) with an average of ≥3 to < 7 weekly complete spontaneous bowel movements (CSBM) were randomized to either Unique IS2 (2 billion Colony Forming Units/day) or placebo for 4 weeks. The primary outcome was the change in bowel movement (BM) frequency after 4 weeks. Secondary outcomes included change in stool consistency (assessed by Bristol Stool Form Scale), GI symptoms and quality of life (Gastrointestinal Quality of Life Index), gut microbiota composition (16S rRNA sequencing), and the proportion of CSBM to total BM.

Results: After 4 weeks of supplementation with Unique IS2 there was a significant increase in BM frequency compared to baseline (P = 0.037). Stool consistency significantly improved after each week in the Unique IS2 group (all P < 0.05) and was significantly improved compared to a placebo after 4 weeks (P = 0.018). These improvements were likely related to a significant improvement in hard stool incidence (P = 0.001). No effects of Unique IS2 supplementation were demonstrated on GI symptoms and quality of life, gut microbiota composition, or proportion of CSBM to total BM.

Conclusions: Our results suggest that Unique IS2 improves stool characteristics in generally healthy individuals with hard stools and poor stool quality over a supplementation period of 4 weeks. Further research is needed to confirm the probiotic potential of Unique IS2 in healthy populations.

Funding Sources: Financial support for this study was provided by PepsiCo, Inc. The views expressed in this abstract are those of the authors and do not reflect the position or policy of PepsiCo, Inc.