Vibrating Capsule Increases CSBMs in Chronic Constipation, with Anthony Lembo, MD

New research is shedding light on the utility of the Vibrating Capsule for increasing both morning and evening complete spontaneous bowel movements (CSBMs) in patients with chronic idiopathic constipation (CIC).1

Findings from the post hoc analysis of the phase 3 trial supporting the Vibrating Capsule’s US Food and Drug Administration approval were presented at Digestive Disease Week (DDW) 2025 by Anthony Lembo, MD, director of research for Cleveland Clinic’s Digestive Disease Institute, and suggest the Vibrating Capsule may provide patients with more predictable regularity, potentially translating to improvements in quality of life and constipation.1

The phase 3, double-blind, placebo-controlled trial enrolled 312 patients with chronic constipation who were randomly assigned to receive either a vibrating or placebo capsule, once daily, 5 days a week for 8 weeks.2

Results of the primary analysis supporting its FDA approval showed a greater percentage of patients receiving the Vibrating Capsule achieved both primary efficacy endpoints for an increase of ≥ 1 CSBMs per week or ≥ 2 CSBMs per week from baseline during ≥ 6 of the 8 weeks (39.3% vs 22.1%; P = .001 and 22.7% vs 11.4%; P = .008, respectively). Additionally, significantly greater improvements were seen with the Vibrating Capsule for the secondary endpoints of straining, stool consistency, and quality-of-life measures compared with placebo.2

In the post hoc analysis presented at DDW, Lembo and colleagues examined the diurnal distribution of CSBMs in this trial. Daily eDiaries recorded the number of CSBMs and the time of their occurrence, along with other constipation-related symptoms such as stool consistency and straining 2 weeks prior to randomization and up to 8 weeks of treatment with the Vibrating Capsule.1

“This is a little unique, because most constipation trials have just looked at CSBMs or SBMs independent of what time of the day it was,” Lembo explained to HCPLive. “The way the device is and because it's electronic, you know when it was activated, so you actually know when patients took it and if they took the device. Patients also reported when they had a bowel movement, which is kind of the unique thing about it, so we looked at the time of day that patients had it.”

Results showed the Vibrating Capsule increased the total number and altered the daily distribution of CSBMs compared to the baseline period. During treatment with the Vibrating Capsule, investigators observed 2 distinct peaks in occurrence of CSBMs, the first in the morning and the second in the evening, coinciding with the second vibration sequence. In contrast, during the baseline period, there was a much less notable CSBM peak in the morning.1

Further analysis revealed Vibrating Capsule treatment resulted in a significantly greater proportion of occurrence of CSBMs (26% vs 16%; P <.05) during the evening when compared to baseline and led to a greater cumulative average number of CSBMs.1

“Understanding the diurnal patterns of people with constipation is important to do,” Lembo said. “It goes back to what patients want, which is predictability of bowel movements.”

Editors’ note: Lembo has relevant disclosures with Atmo, BioAmerica, GSK, Ironwood, Takeda, Ardelyx, and Evoke.

References

1. Lembo A, Quigley EM, Rao SSC, et al. DIURINAL DISTRIBUTION OF CSBMS (COMPLETE SPONTANEOUS BOWEL MOVEMENT) IN CHRONIC IDIOPATHIC CONSTIPATION (CIC) PATIENTS TREATED WITH A VIBRATING CAPSULE. Abstract presented at Digestive Disease Week 2025 in San Diego, CA, from May 3 - May 6, 2025.

2. Rao SSC, Quigley EM, Chey WD, et al. Randomized Placebo-Controlled Phase 3 Trial of Vibrating Capsule for Chronic Constipation. Gastroenterology. 10.1053/j.gastro.2023.02.013