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June 04, 2025
Guelph, ON, June 4, 2025 - SGS Nutrasource collaborated with PepsiCo to complete the first randomized clinical trial in healthy adults to assess Bacillus coagulans Unique IS2 with the goal of improving stool characteristics and reducing gastrointestinal (GI) symptoms. After 4 weeks of 2 billion CFU daily supplementation, Unique IS2 was found to be safe, well tolerated, and significantly improved bowel movement (BM) quality in healthy adults – all of which exhibited functional constipation at baseline.
Participants were eligible if they averaged at least 3 and fewer than 7 spontaneous bowel movements per week. Daily supplementation of Unique IS2 for 4 weeks significantly improved stool consistency (assessed by the Bristol Stool Form Scale) and significantly reduced the incidence of hard stools compared to the placebo group.
Dr. Stephanie-Anne Girard, Director of Scientific Affairs at SGS Nutrasource comments, “This high-quality clinical study demonstrates that daily probiotic supplementation can meaningfully improve stool form in individuals with functional constipation. In a healthy yet symptomatic population with limited non-pharmacological options, these findings highlight the probiotic’s potential to support bowel regularity and gastrointestinal comfort.”
Probiotics have been increasingly studied for their potential benefits in supporting stool quality and the reduction of GI symptoms. While some evidence suggests that Unique IS2 may offer improvements, research to date has primarily focused on individuals with pre-existing GI conditions. To address this gap, SGS Nutrasource and PepsiCo collaborated to investigate the effects of this probiotic supplement in healthy adults.
“This work highlights the challenge of probiotic interventions having significant improvements in generally healthy populations—where there's often less room for change. At the same time, it reinforces the importance of well-designed clinical trials to rigorously evaluate the potential of individual biotics, even in populations already near the healthy threshold," said Dr. Leila Shinn, Associate Principal Scientist in PepsiCo’s Life Sciences.
With digestive health issues affecting tens of millions of people in the United States, Unique IS2 is a promising strategy to improve stool characteristics of individuals with hard stools and occasional constipation.
To learn more about this research, click here.
About SGS Nutrasource
SGS Nutrasource is a leading nutraceutical and pharmaceutical life sciences company focused on helping clients commercialize health and wellness products. In addition to a unique offering of clinical trial management, strategic and regulatory support services along with a state-of-the-art clinical trial site, SGS Nutrasource offers a series of third-party natural ingredient product certification programs (NutraStrong™, IFOS™, IKOS™, IAOS™, IGEN™, IPRO™, and Radioactivity Tested & Certified™.) Learn more at https://www.nutrasource.ca/