NCT06526767

Comparative Study of Different Dosages of Vibrabot Capsule in the Treatment of Chronic Functional Constipation

Comparative Study of Different Dosages of Disposable Gastrointestinal Vibrating Capsule (Vibrabot Capsule) in the Treatment of Mild to Moderate Chronic Functional Constipation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• 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 that enrolls 120 18- to 85-year-old patients with mild to moderate chronic functional constipation to study the dose-response relationship of the Vibrabot capsule as well as the mechanism of action of the Vibrabot capsule.

Detailed description

This study was a single-center, prospective, randomized, parallel-controlled 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. Participants with chronic functional constipation enrolled in the study completed a two-week baseline period in which they were advised to avoid taking any laxatives or other treatments for their constipation as much as possible. After the two-week basal period, all subjects were randomly assigned to the control group, trial group 1, trial group 2, and trial group 3 for the corresponding treatment. Control group: Vibrabot capsule was taken twice a week, one pill/time (on Monday and Thursday), for six weeks; Trial group 1: Vibrabot capsule administration and dosage were three times a week, one pill/time (Monday, Wednesday, and Friday) for six consecutive weeks; Trial group 2: Vibrabot capsule administration and dosage five times a week, one pill/time (Monday, Tuesday, Wednesday, Friday, and Saturday), for six weeks; Trial group 3: Vibrabot capsule administration and dosage for the first two weeks, five times a week, one pill/time (Monday, Tuesday, Wednesday, Friday, and Saturday); for the middle two weeks, three times a week, one pill/time (Monday, Wednesday, and Friday); and for the last two weeks, two times a week, one pill/time (Monday and Thursday). The subjects who receive Vibrabot capsules will undergo 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. 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
DEVICE	Vibrabot capsules twice a week	Subjects in control group took Vibrabot capsules twice a week, one pill/time (on Monday and Thursday), for six weeks.
DEVICE	Vibrabot capsules three times a week	Subjects in trial group 1 took Vibrabot capsules three times a week, one pill/time (Monday, Wednesday, and Friday) for six consecutive weeks.
DEVICE	Vibrabot capsules five times a week	Subjects in trial group 2 took Vibrabot capsules five times a week, one pill/time (Monday, Tuesday, Wednesday, Friday, and Saturday), for six weeks.
DEVICE	Vibrabot capsules loading dose	Subjects in trial group 3 took Vibrabot capsules one pill/time, five times a week (Monday, Tuesday, Wednesday, Friday, and Saturday) during the first two weeks, three times a week (Monday, Wednesday, and Friday) during the middle two weeks, and two times a week (Monday and Thursday) during the last two weeks.

Timeline

• Start date: 2024-05-23
• Primary completion: 2025-09-30
• Completion: 2025-12-31
• First posted: 2024-07-30
• Last updated: 2024-07-30

Locations

1 site across 1 country: China