Effect of Vibration Capsule on Different Subtypes of Functional Constipation
NCT ID: NCT06408883
Last Updated: 2024-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
600 participants
OBSERVATIONAL
2024-06-01
2026-07-01
Brief Summary
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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).
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Detailed Description
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Constipation affects patients' quality of life, and some patients abuse laxatives or repeatedly seek medical treatment, increasing medical costs. The main treatments for constipation are adjusting lifestyle, medication, psychotherapy, biofeedback, and surgery. However, these methods often have side effects, and patient satisfaction is still relatively low. A new approach needs to be explored to address this clinical problem.
The Disposable Gastrointestinal Vibrating Capsule System (Vibrabot capsule) (NMPA Device Approval No. 20223090282) is the world's first approved and marketed product for treating constipation through purely physical means. It can provide intermittent comfortable massages to the digestive tract, activate the intestinal neural network, awaken intestinal motility, and help alleviate constipation issues. Clinical study results show that the product is safe to use and can increase the frequency of bowel movements in patients with chronic functional constipation.However, it remains unknown whether there are differences in treatment outcomes for patients with different subtypes of functional constipation.
In this study, we conducted a clinical study on patients with different subtypes of functional constipation to compare their therapeutic effects in patients with different subtypes.
Patients will be divided into groups according to the results of colonic transit test, balloon push-out test, defecography and anorectal manometry.
1. 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).
2. 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.
Each patient will undergo a series of study visits, including screening, treatment visit, and follow-up visit. The visit process is briefly described as follows:
Visit 1 (0 \~ 1 day) - Baseline/Screening Period:
This visit includes:
The patient will sign an informed consent form; Set the inclusion/exclusion criteria; Guide patients to fill out the questionnaire using the Official Account and complete the Baseline Period Questionnaire in the Official Account.
Prescription Vibrabot capsule treatment or other treatment options.
Visit 2 (Week 2 ±3 days) - Treatment Period 1:
This visit includes:
Fill out the Daily Bowel Movement Questionnaire in the WeChat Official Account every day, take Vibrabot capsules on time or opt for other treatment plans; Fill out the Constipation Symptom Self-Assessment Scale and Assessment Scale for Quality of Life with Constipation in the Official Account every 2 treatment weeks.
Record adverse events and concomitant treatments; Prescription Vibrabot capsules or other treatment options. Visit 3 (Week 4±3 days) - Treatment Period 2
This visit includes:
Fill out the Daily Bowel Movement Questionnaire in the WeChat Official Account every day, take Vibrabot capsules on time or opt for other treatment plans; Fill out the Constipation Symptom Self-Assessment Scale and Assessment Scale for Quality of Life with Constipation in the Official Account every 2 treatment weeks.
Record adverse events and concomitant treatments; Prescription Vibrabot capsules or other treatment options. Visit 4 (Week 6 ±3 days) - Treatment Period 3
This visit includes:
Fill out the Daily Bowel Movement Questionnaire in the WeChat Official Account every day, take Vibrabot capsules on time or opt for other treatment plans; Fill out the Constipation Symptom Self-Assessment Scale and Assessment Scale for Quality of Life with Constipation in the Official Account every 2 treatment weeks.
Record adverse events and concomitant treatments.
Visit 5 (Week 10±3 days) - Follow-up Period:
This visit includes:
Fill out the Daily Bowel Movement Questionnaire in the WeChat Official Account every day; Fill out the Constipation Symptom Self-Assessment Scale and Assessment Scale for Quality of Life with Constipation in the Official Account every 2 treatment weeks; Record adverse events and concomitant treatments.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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normal transit constipation group
Patients with confirmed normal transit constipation.
Vibrabot capsule
Main 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.
dyssynergic defecation group
Patients with confirmed dyssynergic defecation.(abnormal balloon expulsion test and/or high anal sphincter pressure and/or failure of the anorectal angle to open)
Vibrabot capsule
Main 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.
slow-transit constipation group
Patients with confirmed slow-transit constipation.(diagnosed by colon transit scintigraphy)
Vibrabot capsule
Main 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.
slow-transit constipation + dyssynergic defecation
Patients with confirmed slow-transit constipation and dyssynergic defecation.
Vibrabot capsule
Main 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.
Interventions
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Vibrabot capsule
Main 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.
Eligibility Criteria
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Inclusion Criteria
Patients who consent to participate in this trial and voluntarily sign the informed consent form (ICF).
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Shanghai Tongji Hospital, Tongji University School of Medicine
OTHER
Shanghai 10th People's Hospital
OTHER
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Shanghai 6th People's Hospital
OTHER
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
OTHER
Shanghai Pudong New Area Gongli Hospital
OTHER
Changhai Hospital
OTHER
Responsible Party
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Locations
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Changhai hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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References
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Scott SM, Simren M, Farmer AD, Dinning PG, Carrington EV, Benninga MA, Burgell RE, Dimidi E, Fikree A, Ford AC, Fox M, Hoad CL, Knowles CH, Krogh K, Nugent K, Remes-Troche JM, Whelan K, Corsetti M. Chronic constipation in adults: Contemporary perspectives and clinical challenges. 1: Epidemiology, diagnosis, clinical associations, pathophysiology and investigation. Neurogastroenterol Motil. 2021 Jun;33(6):e14050. doi: 10.1111/nmo.14050. Epub 2020 Dec 2.
Zhu JH, Qian YY, Pan J, He C, Lan Y, Chen WN, Wang BM, Zhao W, Li JN, Li XQ, Lv B, Fan YH, Zuo XL, Li Z, Zou DW, Li ZS, Liao Z. Efficacy and safety of vibrating capsule for functional constipation (VICONS): A randomised, double-blind, placebo-controlled, multicenter trial. EClinicalMedicine. 2022 Apr 25;47:101407. doi: 10.1016/j.eclinm.2022.101407. eCollection 2022 May.
Camilleri M, Kerstens R, Rykx A, Vandeplassche L. A placebo-controlled trial of prucalopride for severe chronic constipation. N Engl J Med. 2008 May 29;358(22):2344-54. doi: 10.1056/NEJMoa0800670.
Other Identifiers
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ANKONYX20231212
Identifier Type: -
Identifier Source: org_study_id
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