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New treatment option for Chronic Functional Constipation
Official title Comparative Study of Different Dosages of Vibrabot Capsule in the Treatment of Chronic Functional Constipation
ClinicalTrials.gov ID: NCT06526767
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join 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...
- 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;
You likely can't join 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.
See the full eligibility 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:
- 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. 3\. People who had a colonoscopy within...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.