Effect of Vibration Capsule on Different Subtypes of Functional Constipation

Launched by CHANGHAI HOSPITAL · May 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how effective a treatment called Vibrabot capsules is for people with chronic functional constipation, a condition where it's difficult to have regular bowel movements. The researchers plan to include 600 patients and will group them based on different types of constipation. Participants will take the capsules while following a diet and exercise plan recommended by their doctors. Throughout the study, they will provide information about their bowel movements through an electronic questionnaire.

To be eligible for this trial, participants need to be diagnosed with functional constipation based on specific criteria and must agree to join the study by signing a consent form. However, certain individuals, such as those with severe gastrointestinal issues or specific medical conditions, will not be able to participate. The study is not yet recruiting, but once it begins, patients can expect to help researchers understand if the Vibrabot capsules can improve their condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients who can be diagnosed with functional constipation according to the Rome IV criteria.
• • Patients who consent to participate in this trial and voluntarily sign the informed consent form (ICF).
• Exclusion Criteria:
• • 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; Pregnant women; People with severe depression and anxiety and severe acute gastrointestinal lesions.
• • People with other conditions, so the investigator considers them not eligible for this study.