Comparative Study of Different Dosages of Vibrabot Capsule in the Treatment of Chronic Functional Constipation
Launched by BEIJING TSINGHUA CHANG GUNG HOSPITAL · Jul 24, 2024
Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring the effectiveness of different dosages of a medication called Vibrabot capsule in treating chronic functional constipation, a condition where bowel movements are infrequent or difficult. The study will involve 120 participants aged between 18 and 85 years who experience mild to moderate constipation symptoms, such as straining during bowel movements or having hard stools. To participate, individuals must meet specific criteria, including having symptoms that have been present for at least six months and not finding relief from previous treatments.
Participants in the trial can expect to take the Vibrabot capsule and will be monitored to see how well it works at different dosages. The study will help researchers understand how the medication works and its potential benefits for people suffering from chronic constipation. It's important for interested individuals to know that they will need to provide informed consent and may undergo assessments to ensure they meet the eligibility requirements.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • - 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:
- 1. 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;
- • 2. Loose stools are rarely present without the use of laxatives.
- • 3. 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:
- • 1. 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.
- • 2. Moderate: The symptoms are between mild and severe symptoms.
- • 3. Severe: The symptoms are severe and persistent, seriously affecting work and life, and requiring medications, and medications cannot be stopped, or medications are ineffective.
- • 3. People who had a colonoscopy within three years before screening and had negative results, or whose 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 (which takes about 1-4 weeks).
- • 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, can communicate with the investigator, 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. People with severe depression and anxiety and severe acute gastrointestinal lesions.
- • 8. 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.
- • 9. 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).
- • 10. People who plan to undergo MRI in the near future.
- • 11. Pregnant women or women with pregnancy plans in the next year.
- • 12. People with other conditions, so the investigator considers them not eligible for this study.
About Beijing Tsinghua Chang Gung Hospital
Beijing Tsinghua Chang Gung Hospital is a leading medical institution in China, known for its commitment to advancing healthcare through innovative clinical research and trial sponsorship. Affiliated with Tsinghua University and Chang Gung Memorial Hospital, the facility combines cutting-edge medical technology with a robust academic framework to facilitate high-quality clinical trials. The hospital specializes in a range of therapeutic areas, focusing on improving patient outcomes and contributing to global medical knowledge. With a multidisciplinary team of experts, Beijing Tsinghua Chang Gung Hospital is dedicated to fostering collaborations that enhance the efficacy and safety of new treatments.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Beijing, Beijing, China
Patients applied
Trial Officials
Xuan Jiang, Professor
Principal Investigator
Beijing Tsinghua Changung Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported