Vibrabot Capsule for Chronic Functional Constipation
Comparative Study of Different Dosages of Vibrabot Capsule in the Treatment of Chronic Functional Constipation
Recruiting
N/AInterventional Study
Chronic Functional Constipation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 85
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
Beijing Tsinghua Chang Gung Hospital · Other
Who this trial is looking for
This trial is looking for adults aged 18 to 85 who have moderate to severe constipation. Participants will take the Vibrabot capsule to see how well it works and how it works in the body.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 85 years old.
I have been diagnosed with moderate to severe functional constipation.
I have not had a colonoscopy in the last three years with negative results.
I understand and agree to participate in this trial.
You may not be able to join if
I am not eligible for surgery.
I have known or suspected gastrointestinal problems.
I am allergic to polymeric materials.
I have had gastrointestinal surgery in the last three months.
I have severe depression or anxiety.
I am pregnant or planning to get pregnant in the next year.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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-fo…
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.
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