NCT06553664

The Efficacy of Long-Course Treatment Using Vibrating Capsules for Chronic Constipation

The Efficacy of Long-Course Treatment Using Disposable Gastrointestinal Vibrating Capsule (Vibrabot Capsule) for Chronic Constipation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Beijing Tsinghua Chang Gung Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center trial. It enrolled nine 18- to 85-year-old patients with chronic constipation to evaluate the efficacy of long-course treatment by using vibrating capsule (VC).

Detailed description

This study was a single-center prospective, single-arm exploratory clinical trial. If a subject signs an Ethics Committee (EC)-approved study informed consent (ICF) that meets the inclusion criteria and does not meet any of the exclusion criteria, the subject is considered eligible for admission to the study. After completing a baseline questionnaire on bowel movements over the most recent 2 weeks, participants took VC at least 7 weeks, doses ranging from 2 to 5 capsules orally per week. After completion of treatment, subjects entered a follow-up period for at least 8 weeks. During the study period, the subjects are required to keep an e-diary recording daily bowel movements (BMs), medication intake, and discomforts, and complete the Patient Assessment of Constipation Symptoms (PAC-SYM) and the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaires every two weeks. Subjects are not expected to change their diet or lifestyle during the study. If the subject has not had a bowel movement for three or more consecutive days, the subject is allowed to use another method of defecation to assist with defecation. Subjects are required to avoid antibiotics, probiotics, prebiotics, and proton pump inhibitors throughout their participation in the study.

Conditions

• Chronic Functional Constipation

Interventions

Type	Name	Description
DRUG	Treat with Vibrabot capsules for at least 7 weeks	Subjects in the trial group took Vibrabot capsules at least 7 weeks, doses ranging from 2 to 5 capsules orally per week.

Timeline

• Start date: 2023-07-28
• Primary completion: 2023-10-07
• Completion: 2023-12-02
• First posted: 2024-08-14
• Last updated: 2024-08-19

Locations

1 site across 1 country: China