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).

Early symptoms preceding post-infectious irritable bowel syndrome following COVID-19: a retrospective observational study incorporating daily gastrointestinal symptoms.

BACKGROUND: Intestinal microinflammation with immune dysfunction due to severe acute respiratory syndrome coronavirus 2 reportedly precipitates post-infectious irritable bowel syndrome. This study aimed to elucidate potential risk factors for subsequent development of irritable bowel syndrome, hypothesizing that it is associated with specific symptoms or patient backgrounds. METHODS: This single-center retrospective observational study (2020-2021) included adults with confirmed coronavirus disease requiring hospital admission and was conducted using real-world data retrieved from a hospital information system. Patient characteristics and detailed gastrointestinal symptoms were obtained and compared between patients with and without coronavirus disease-induced irritable bowel syndrome. Multivariate logistic models were used to validate the risk of developing irritable bowel syndrome. Moreover, daily gastrointestinal symptoms during hospitalization were examined in patients with irritable bowel syndrome. RESULTS: Among the 571 eligible patients, 12 (2.1%) were diagnosed with irritable bowel syndrome following coronavirus disease. While nausea and diarrhea during hospitalization, elevated white blood cell count on admission, and intensive care unit admission were associated with the development of irritable bowel syndrome, nausea and diarrhea were identified as risk factors for its development following coronavirus disease, as revealed by the adjusted analyses (odds ratio, 4.00 [1.01-15.84] and 5.64 [1.21-26.31], respectively). Half of the patients with irritable bowel syndrome had both diarrhea and constipation until discharge, and constipation was frequently followed by diarrhea. CONCLUSIONS: While irritable bowel syndrome was rarely diagnosed following coronavirus disease, nausea and diarrhea during hospitalization precede the early signs of irritable bowel syndrome following coronavirus disease.

Association between multiple sleep dimensions and functional bowel disorders among Chinese college freshmen.

BACKGROUND: Although sleep disorder is thought as a risk factor for functional bowel disorders, its impact role in adolescents remains unknown and the contribution of different sleep dimensions may deserve further attention. This study aimed to evaluate the relationship between multiple sleep dimensions and functional bowel disorders among Chinese college freshmen. METHODS: A cross-sectional survey was conducted in college freshmen from Huazhong University of Science and Technology in Wuhan, China in September 2019 with random cluster sampling method. All participants completed questionnaires about living habits, sleep and digestive symptoms. Diagnosis of irritable bowel syndrome and functional constipation were based on the Rome IV criteria. Univariate and multivariate logistic regression models were applied to assess the association of sleep dimensions with irritable bowel syndrome or functional constipation. RESULTS: Based on the 3335 individuals who completed the questionnaire, the overall prevalence of irritable bowel syndrome and functional constipation in college freshmen were 2.5% and 1.7%, respectively. Multivariate analysis revealed that compared with individuals reporting good sleep quality, those reporting poor (OR = 7.269, 95%CI: 2.876-18.370) were associated with increased risk of irritable bowel syndrome. Similarly, those reporting fair (OR = 2.068, 95%CI: 1.010-4.236) and poor (OR = 5.664, 95%CI: 1.864-17.205) were associated with increased risk of functional constipation. There was no statistically significant association between other sleep dimensions (sleep duration, sleep timing, or sleep latency) and irritable bowel syndrome or functional constipation. CONCLUSION: Self-reported poor sleep quality was a stronger independent predictor of functional bowel disorders than other sleep dimensions among Chinese college freshmen. Future intervention studies should consider the role of sleep quality for the prevention of FBDs in adolescents.