Effects of a spore-forming probiotic blend on bowel habits and physical well-being in adults with functional constipation: A randomized, double-blind, placebo-controlled trial

Clinical Snapshot

Key Findings

• P Value: Multiple significant outcomes: irritant bowel movements (p = 0.0458), incomplete evacuation (p = 0.0374), abdominal pain (p = 0.0090), stool consistency (p = 0.0176), physical functioning (p = 0.0300)

• Effect Size: Significant improvements in irritant bowel movements, incomplete evacuation, and abdominal pain

• Primary Outcome: Improvements in weekly spontaneous bowel movements and stool form, with shift toward normal Bristol types 3-4 (p = 0.0176)

• Nnt Or Sensitivity: Not calculable from available data

• Confidence Interval: Not reported in abstract

Clinical Application

Probiotic supplementation is generally feasible in primary care settings, though specific product availability and dosing protocols need clarification Functional constipation is common in Australian practice. Probiotics are available over-the-counter but specific spore-forming blends may have limited TGA registration. Would complement existing RACGP guidelines for constipation management Adults with functional constipation meeting Rome IV criteria, particularly those with incomplete evacuation, abdominal pain, and poor stool consistency

Abstract

We aimed to evaluate the efficacy and safety of a spore-forming probiotic blend containing Clostridium butyricum IDCC 1301, Weizmannia coagulans IDCC 1201, and Bacillus subtilis IDCC 1101 for improving bowel function and well-being in adults with functional constipation (FC). In a randomized, double-blind, placebo-controlled trial, 78 adults with FC (Rome IV criteria) received either probiotic blend (n = 40) or placebo (n = 38) daily for 4 weeks. Primary outcomes were changes in weekly spontaneous bowel movements (WSBM) and stool form. Secondary outcomes included physical functioning scores from the 36-Item Short Form Health Survey. The probiotic blend group showed significant improvements in irritant bowel movements (p = 0.0458), incomplete evacuation (p = 0.0374), and abdominal pain before defecation (p = 0.0090). Stool consistency shifted toward normal types (Bristol types 3-4, p = 0.0176). Physical functioning improved only in the probiotic blend group (p = 0.0300). Probiotic blend effectively alleviated symptoms of FC and improved physical well-being. Trial registration: Clinical Research Information Service (CRIS), KCT0010085.

References

1. 1.Park, H. G., Lee, H. B., Lee, M., Park, H., Kang, M., Bok, M., Hwang, Y., Jeong, K., Maeng, S., Lim, H., & Moon, J. S. (2026). Effects of a spore-forming probiotic blend on bowel habits and physical well-being in adults with functional constipation: A randomized, double-blind, placebo-controlled trial. *PLoS One*. https://doi.org/10.1371/journal.pone.0337019