Comparing Vibrabot Capsule and Polyethylene Glycol for Chronic Constipation

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

This study is testing whether Vibrabot capsules work better than polyethylene glycol for treating moderate to severe chronic constipation in adults.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Beijing Tsinghua Chang Gung Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06364111 on ClinicalTrials.gov

What this trial studies

This clinical trial is designed to evaluate the efficacy of Vibrabot capsules compared to polyethylene glycol in treating moderate to severe chronic functional constipation. It involves a single-center, prospective, parallel controlled approach with 20 participants aged 18 to 85. Patients will be randomly assigned to receive either Vibrabot capsules, polyethylene glycol, or a combination of both over a treatment period of up to 12 weeks, with various assessments conducted to understand the mechanism of action. The study includes follow-up periods to monitor symptom recurrence and treatment efficacy.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 85 with moderate to severe functional constipation as defined by the Rome IV criteria.

Not a fit: Patients with constipation caused by identifiable structural abnormalities or those who have undergone recent colonoscopy with significant findings may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from chronic functional constipation.

How similar studies have performed: While there have been studies on polyethylene glycol for constipation, the specific use of Vibrabot capsules in this context is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. People with moderate to severe functional constipation according to Rome IV criteria.
2. People who agree to use appropriate medical methods of contraception from the time they sign the ICF until the end of the treatment period (excluding women in a medical sterilization status).
3. People who had a colonoscopy within three years before screening and negative results, or their colonoscopy results are judged by the investigator as mild anomalies, but the cause of their constipation cannot be explained. If the colonoscopy report is unavailable, the study physician will determine if a colonoscopy is needed. If the subjects undergo a colonoscopy after signing the ICF, they will not enter the treatment period until their BMs return to the baseline level.
4. People had colonic polyps and a polypectomy (except for endoscopic submucosal dissection (ESD)): Those with a polyp ≤1 cm can be enrolled one month after the polypectomy; Those with a polyp \>1 cm can be enrolled three months after the polypectomy.
5. People who consent to participate in this trial and can communicate with the investigator and can understand and comply with the relevant procedures and requirements during the study (including completing study questionnaires on time, being treated and visited as scheduled, and undergoing relevant examinations), and voluntarily sign the ICF.

Exclusion Criteria:

1. People who are not eligible for surgery or refuse to undergo any abdominal surgery.
2. People with known or suspected gastrointestinal obstruction, stenosis, diverticulum, bleeding, malformation, and fistula.
3. People allergic to polymeric materials.
4. People implanted with cardiac pacemakers and using gastrointestinal pacemakers.
5. People with abdominal aortic aneurysms, gastrointestinal vascular lesions, ulcers, and lesions with bleeding tendencies.
6. People with dysphagia.
7. Pregnant women or women with pregnancy plans in the next year.
8. People with severe depression and anxiety and severe acute gastrointestinal lesions.
9. 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.
10. 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).
11. People who plan to undergo MRI in the near future.
12. People with other conditions, so the investigator considers them not eligible for this study.

Where this trial is running

Beijing, Beijing

• XuanJiang — Beijing, Beijing, China (Recruiting)

Study contacts

• Principal investigator: Xuan Jiang, Professor — Beijing Tsinghua Changung Hospital
• Study coordinator: Xuan Jiang, Professor

Conditions Chronic Functional Constipation