Effect of Vibration Capsule on Different Subtypes of Functional Constipation
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChanghai Hospital
About this trial
This study is a multi-center prospective cohort study, which plans to include 600 patients with chronic functional constipation to treat with Vibrabot capsules and patients will be grouped according to subtypes.
During the study, the patients' basic information, baseline constipation status and treatment information, capsule intake during treatment, and concomitant medication will be collected. During the treatment phase, patients follow the doctor's advice to receive Vibrabot capsule treatment and maintain stable dietary intake and exercise according to the constipation diagnosis and treatment guidelines.
During the study, patients need to fill in the relevant information during the treatment in the electronic questionnaire in a timely and truthful manner. The treatment effect of the patients is evaluated by assessing the number of occurrences of spontaneous bowel movements (SBM) and complete spontaneous bowel movements (CSBM).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
This study is a multi-center clinical trial. Patients are considered eligible for this study if they meet the inclusion criteria and do not meet any of the exclusion criteria. This study plans to include 600 patients with chronic functional constipation to treat with Vibrabot capsules for at least 6 weeks.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Vibrabot capsule
DeviceMain parameters of Vibrabot capsule: nominal diameter: 11.8±1mm; nominal length: 26.7±1mm; nominal weight: 4.5±1g. After the patient swallows the Vibrabot capsule, the capsule runs through the stomach → duodenum → jejunum and ileum → colon. According to the clinical data and configuration settings, the capsule will reach the colon and vibrate 8 hours after activation for ≥ 180 minutes in a cycle at low, medium, and high frequencies sequentially. The capsule relieves and treats constipation by massaging the colon wall through motor vibration to relieve colon muscle spasms and promote colonic peristalsis. The VC well be taken between 21:00 and 22:00 every day, and the frequency of administration is determined based on the patient's individual situation.
Treatment groups
600 Participants
are divided into 4 treatment groupsGroup A: normal transit constipation group1 intervention
Group B: dyssynergic defecation group1 intervention
Group C: slow-transit constipation group1 intervention
Group D: slow-transit constipation + dyssynergic defecation1 intervention
Trial outcomes
Primary outcomes
1
After treatment, whether the response rate of patients using the Vibrabot vibrating capsules alone reaches 50%.
The definition of the responder is a patient with an average weekly increase of ≥1 complete spontaneous bowel movement (CSBM) compared to the baseline.
Time frame
At the end of the sixth week of treatmentSecondary outcomes
1
Proportion of constipated patients who use/do not use other constipation treatment methods
Collect relevant data through daily defecation questionnaires.
Time frame
At the end of the sixth week of treatment2
Proportion of constipated patients who use/do not use other constipation treatment methods
Collect relevant data through daily defecation questionnaires.
Time frame
at the end of the 4-week follow-up3
Proportion of patients with an average increase of ≥1 CSBMs per week compared to the baseline period
Collect relevant data through daily defecation questionnaires,CSBM refers to spontaneous defecation without anal obstruction and without taking laxatives within 24 hours before defecation.
Time frame
At the end of the sixth week of treatment4
Proportion of respondents with an average of ≥3 SBMs per week during the treatment period
Collect relevant data through daily defecation questionnaires, SBM refers to spontaneous defecation without taking laxatives within 24 hours before defecation.
Time frame
At the end of the sixth week of treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Changhai Hospital
Lead sponsor
Ruijin Hospital
Collaborator
Shanghai Tongji Hospital, Tongji University School of Medicine
Collaborator
Shanghai 10th People's Hospital
Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Shanghai 6th People's Hospital
Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Collaborator
Shanghai Pudong New Area Gongli Hospital
Collaborator
Source ClinicalTrials.gov
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