{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T08:08:31Z","timestamp":1791533311210,"version":"4.3.4"},"reference-count":32,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2025,3,10]],"date-time":"2025-03-10T00:00:00Z","timestamp":1741564800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Neurogastroenterology Motil"],"published-print":{"date-parts":[[2025,5]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Chronic idiopathic constipation (CIC) remains a significant problem globally with increasing estimates for disease burden. In a Phase 3 placebo\u2010controlled trial, a novel treatment using the Vibrating Capsule was recently shown to be effective in treating patients with CIC. However, its safety and tolerability has not been described in detail.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We analyzed safety data from six trials encompassing the development of the Vibrating Capsule, including, dose\u2010ranging and pivotal studies. The incidence of adverse events, treatment discontinuation, tolerability and satisfaction were assessed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Key Results<\/jats:title><jats:p>A total of 800 patients who took either an active Vibrating Capsule or a sham\/placebo (non\u2010vibrating) but similar capsule from 6 studies were included in this post hoc analysis. The most common adverse gastrointestinal events were bloating (2.9%), abdominal pain (2.9%), nausea (2.3%) and diarrhea (1.9%). A sensation of vibration was reported by 11.7% of patients. The adverse events rates were low, and investigators categorized most of them as unrelated to treatment. There were no serious adverse events such as retention of therapeutic capsules and no patient stopped therapy or withdrew due to adverse effects. The majority of patients (83%) found the system convenient, with an overall treatment satisfaction rate of 71%.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions and Inferences<\/jats:title><jats:p>The Vibrating Capsule, a first in class treatment for CIC was found to be safe and well tolerated by patients in clinical trials. No patient discontinued treatment due to adverse events.<\/jats:p><\/jats:sec>","DOI":"10.1111\/nmo.15004","type":"journal-article","created":{"date-parts":[[2025,3,12]],"date-time":"2025-03-12T05:02:24Z","timestamp":1741755744000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["The Vibrating Capsule: Safety and Tolerability in Patients With Chronic Idiopathic Constipation"],"prefix":"10.1111","volume":"37","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1997-5935","authenticated-orcid":false,"given":"Bryan F.","family":"Curtin","sequence":"first","affiliation":[{"name":"The Institute of Digestive and Liver Diseases at Mercy Medical Center  Baltimore Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eamonn M. M.","family":"Quigley","sequence":"additional","affiliation":[{"name":"Lynda K. and David M. Underwood Center for Digestive Disorders Houston Methodist Hospital and Weill Cornell Medical College  Houston Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William D.","family":"Chey","sequence":"additional","affiliation":[{"name":"University of Michigan  Ann Arbor Michigan USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthony J.","family":"Lembo","sequence":"additional","affiliation":[{"name":"Cleveland Clinic Digestive Disease and Surgery Institute  Cleveland Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Darren M.","family":"Brenner","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology Northwestern University  Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brennan M. R.","family":"Spiegel","sequence":"additional","affiliation":[{"name":"Karsh Division of Gastroenterology and Hepatology, Department of Medicine Cedars\u2010Sinai Medical Center  Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4446-8452","authenticated-orcid":false,"given":"Satish S. 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