Comparative Study on the Efficacy of Vibrabot Capsule and Polyethylene Glycol for Chronic Functional Constipation

Chronic Functional Constipation Clinical Trial

Official title: Comparative Study on the Efficacy of Disposable Gastrointestinal Vibrating Capsule (Vibrabot Capsule) and Polyethylene Glycol for Chronic Functional Constipation

Status Recruiting

Clinical Trial Summary

This is a single-center trial that enrolls 20 18 to 85-year-old patients with moderate to severe FC to study the efficacy of Vibrabot capsule (dosage: 5 capsules/week) and polyethylene glycol, as well as the mechanism of action of the Vibrabot capsule.

Clinical Trial Description

This study is a prospective, parallel controlled clinical trial. Subjects are considered eligible for this study if they meet the inclusion criteria and do not meet any of the exclusion criteria. They must sign an Ethics Committee (EC)-approved Informed Consent Form (ICF) and be randomly assigned to trial group 1, trial group 2 and control group for the respective treatment.

Subjects in Trial Group 1 received polyethylene glycol combined with Vibrabot capsules for 2 weeks and then Vibrabot capsules for 4 weeks; Subjects in Trial Group 2 received Vibrabot capsules for 12 consecutive weeks; Subjects in the control group received polyethylene glycol for 6 weeks, and subjects with poor efficacy could voluntarily choose to continue to receive Vibrabot capsules for 6 weeks. During the treatment period, the dosage of Vibrabot capsule is 1 capsule/time, 5 times/week, and that of polyethylene glycol is 10g/time, twice/day. The subjects who receive Vibrabot capsules will undergo a colonic transit study, a radionuclide imaging-based gastrointestinal transit assessment, an anorectal manometry, a neurotransmitter test, and a fecal flora test before and after the treatment. After completion of treatment, subjects in each group entered a follow-up period, which was observed until the patient regained symptoms of constipation, i.e., when laxatives or other bowel-promoting treatments were used. If the subject never recovered from constipation, a minimum of 8 weeks of questionnaire completion was required, depending on the patient's compliance status. 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.

This study consists of a screening/baseline period, a treatment period and a follow-up period. During the study, subjects are required not to change their diet and lifestyle. The washout or follow-up period will end once the subject uses rescue medication. If subjects have no BM for three or more consecutive days, they are permitted to take bisacodyl as rescue medication. If they cannot tolerate bisacodyl, an enema may be used instead. They should avoid antibiotics, probiotics, prebiotics, and proton pump inhibitors throughout their participation in the study. ;

Related Conditions & MeSH terms

• Chronic Functional Constipation
• Constipation

• NCT number: NCT06364111
• Study type: Interventional
• Source: Beijing Tsinghua Chang Gung Hospital
• Contact: Xuan Jiang, Professor
• Phone: 13671006525
• Email: jxa01998@btch.edu.cn
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2024
• Completion date: August 30, 2025