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

BACKGROUND & AIMS: Despite therapeutic advances, effective 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 constipation. METHODS: We conducted a phase 3, double-blind, placebo-controlled trial of patients with chronic constipation, 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 analyses 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 improvements were seen with the vibrating capsule for the secondary 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).

Safety of Percutaneous Endoscopic Gastrostomy Placement in Patients With SARS-CoV-2 Infection.

Background: Coronavirus disease 2019 (COVID-19) can lead to ventilator-dependent chronic respiratory failure and a need for tube feeding. Percutaneous endoscopic gastrostomy (PEG) placement provides more sustainable longer-term enteral access with fewer side effects compared to the long-term nasogastric tube placement. Bleeding is a recognized complication of PEG placement, and many COVID-19 patients are on antiplatelets/anticoagulants, yet minimal data exist on the safety of PEG tube placement in this context. Methods: A retrospective chart review identified patients who underwent PEG placement between January 2020 and January 2021 at a single institution. Success was defined as PEG placement and use to provide enteral nutrition with no complications requiring removal within 4 weeks. Results: Thirty-six patients with and 104 age- and sex-matched patients without COVID-19 infection were included. More COVID-19 patients were obese, on anticoagulants, had low serum albumin levels and had a tracheostomy in place. Of those patients, 8.3% with COVID-19 developed PEG-related complications compared to 16.3% without (P = 0.28). PEG success rates in patients with and without COVID-19 were similar at 97.2% and 92.3%, respectively (P = 0.44). Conclusion: PEG tube placement is comparatively safe in COVID-19 patients who need long-term enteral access.