Randomized Placebo-Controlled Phase 3 Trial of Vibrating Capsule for Chronic Constipation

BACKGROUND & AIMS: Despite therapeutic advances, effec-tive treatments for chronic constipation remain an unmet need. The vibrating capsule is a nonpharmacologic, orally ingested, programmable capsule that vibrates intraluminally to induce bowel movements. We aimed to determine the efficacy and safety of the vibrating capsule in patients with chronic con-stipation. METHODS: We conducted a phase 3, double-blind, placebo-controlled trial of patients with chronic con-stipation, who were randomized to receive either a vibrating or placebo capsule, once daily, 5 days a week for 8 weeks. The primary efficacy end points were an increase of 1 or more complete spontaneous bowel movements per week (CSBM1 responder) or 2 or more CSBMs per week (CSBM2) from baseline during at least 6 of the 8 weeks. Safety ana-lyses were performed. RESULTS: Among 904 patients screened, 312 were enrolled. A greater percentage of patients receiving the vibrating capsule achieved both primary efficacy end points compared with placebo (39.3% vs 22.1%, P = .001 for CSBM1; 22.7% vs 11.4% P = .008 for CSBM2). Significantly greater im-provements were seen with the vibrating capsule for the sec-ondary end points of straining, stool consistency, and quality-of -life measures compared with placebo. Adverse events were mild, gastrointestinal in nature, and similar between groups, except that a mild vibrating sensation was reported by 11% of patients in the vibrating capsule group, but none withdrew from the trial. CONCLUSIONS: In patients with chronic constipation, the vibrating capsule was superior to placebo in improving bowel symptoms and quality of life. The vibrating capsule was safe and well tolerated. (Clinical trials.gov, Number: NCT03879239)

Automated summary

This study examined the efficacy and safety of a vibrating capsule in patients with chronic constipation. The results showed that the vibrating capsule was superior to placebo in improving bowel symptoms and quality of life. The vibrating capsule was also found to be safe and well tolerated.