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

NCT06526767 | Recruiting DMC

• 1 other identifier: 23648-4-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Functional Constipation

Keywords

Chronic Functional Constipation; Vibrating Capsule; Dose-response Relationship; Mechanism

Outcome Measures

Primary Outcomes (1)

• The proportions of responders to the four therapies during the treatment period.

  Responders are the subjects with an average increase of ≥1 complete spontaneous bowel movements (CSBMs) per week during the treatment period compared to the baseline period.

  6 weeks

Secondary Outcomes (7)

• The changes in neurotransmitter levels before and after treatment with Vibrabot capsules.

  6 weeks of treatment.

• The changes in fecal microbiota before and after treatment with Vibrabot capsules.

  6 weeks of treatment.

• Assessment of quality of life among different treatment groups.

  Every 2 weeks during the treatment period and the follow-up period, up to 14 weeks.

• Assessment of the severity of patient-reported symptoms among different treatment groups.

  Every 2 weeks during the treatment period and the follow-up period, up to 14 weeks.

• The proportions of responders to the four therapies during the follow-up period.

  8 weeks of follow-up.

Study Arms (4)

Control group

EXPERIMENTAL

Subjects in control group took Vibrabot capsules twice a week, one pill/time (on Monday and Thursday), for six weeks.

Device: Vibrabot capsules twice a week

Trial group 1

EXPERIMENTAL

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 three times a week

Trial group 2

EXPERIMENTAL

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 five times a week

Trial group 3

EXPERIMENTAL

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.

Device: Vibrabot capsules loading dose

Interventions

Vibrabot capsules twice a week DEVICE

Subjects in control group took Vibrabot capsules twice a week, one pill/time (on Monday and Thursday), for six weeks.

Control group

Vibrabot capsules three times a week DEVICE

Subjects in trial group 1 took Vibrabot capsules three times a week, one pill/time (Monday, Wednesday, and Friday) for six consecutive weeks.

Trial group 1

Vibrabot capsules five times a week DEVICE

Subjects in trial group 2 took Vibrabot capsules five times a week, one pill/time (Monday, Tuesday, Wednesday, Friday, and Saturday), for six weeks.

Trial group 2

Vibrabot capsules loading dose DEVICE

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.

Trial group 3

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 1.18 to 85-year-old men and women. 2. People with moderate to severe functional constipation according to Rome IV criteria.
• The Rome IV criteria for functional constipation are as follows:
• Must include two or more of the following:
• Straining during more than one-fourth (25%) of defecations;
• Lumpy or hard stools (BSFS 1-2) more than one-fourth (25%) of defecations;
• Sensation of incomplete evacuation more than one-fourth (25%) of defecations;
• Sensation of anorectal obstruction/blockage more than one-fourth (25%) of defecations;
• Manual maneuvers to facilitate more than one fourth (25%) of defecations (e.g., digital evacuation, support of the pelvic floor);
• Fewer than 3 spontaneous bowel movements per week;
• Loose stools are rarely present without the use of laxatives.
• Insufficient criteria for irritable bowel syndrome Criteria fulfilled for the last three months with symptom onset at least six months prior to diagnosis.
• Severity of constipation:
• Mild: The symptoms are mild and do not affect daily life. Normal BMs can be restored through overall adjustment and medication use in a short time.
• Moderate: The symptoms are between mild and severe symptoms.
• Severe: The symptoms are severe and persistent, seriously affecting work and life, and requiring medications, and medications cannot be stopped, or medications are ineffective.

You may not qualify if:

• People who are not eligible for surgery or refuse to undergo any abdominal surgery.
• People with known or suspected gastrointestinal obstruction, stenosis, diverticulum, bleeding, malformation, and fistula.
• People allergic to polymeric materials.
• People implanted with cardiac pacemakers and using gastrointestinal pacemakers.
• People with abdominal aortic aneurysms, gastrointestinal vascular lesions, ulcers, and lesions with bleeding tendencies.
• People with dysphagia.
• People with severe depression and anxiety and severe acute gastrointestinal lesions.
• People who had gastrointestinal surgery or a history of surgery that changed the structure of the gastrointestinal tract (except for appendectomy) or people who underwent gastrointestinal ESD in the past three months.
• People with severe hemorrhoids (patients with grade III-IV hemorrhoids according to the Clinical Practice Guidelines for the Management of Hemorrhoids of the American Society of Colon and Rectal Surgeons).
• People who plan to undergo MRI in the near future.
• Pregnant women or women with pregnancy plans in the next year.
• People with other conditions, so the investigator considers them not eligible for this study.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

XuanJiang

Beijing, Beijing Municipality, 102218, China

RECRUITING

Study Officials

• Xuan Jiang, Professor

  Beijing Tsinghua Changung Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuan Jiang, Professor

CONTACT

13671006525; jxa01998@btch.edu.cn

Ting Yi, Physician

CONTACT

13331154633; withoutsun@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 14, 2024
• First Posted: July 30, 2024
• Study Start: May 23, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)