Effect of Vibration Capsule on Different Subtypes of Functional Constipation

A Prospective Cohort Study On the Efficacy of Vibrating Capsule For Different Subtypes of Chronic Functional Constipation

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Clinical Study; Chronic Functional Constipation
• Intervention / Treatment: Device: Vibrabot capsule

Detailed Description

Constipation is characterized by a decrease in bowel movements, dry and hard stools, and difficulty in defecation. With changes in diet, faster pace of life, and social psychological factors, the prevalence of chronic constipation is on the rise. The global incidence of chronic constipation is 14%, while the prevalence of chronic constipation in adults in China is 4.0% to 10.0%. The prevalence of functional constipation in China is 6%. The high-risk groups for constipation include the elderly, women, diabetics, those taking opiates, antipsychotic drugs, or bedridden patients. Occupation, lifestyle, dietary habits, mental health, family history of constipation, and BMI are factors related to constipation.

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.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Yangyang Qian; Phone Number: +86 13818040017; Email: drfionachien@163.com
• Study Contact Backup: Name: Ji Xia; Phone Number: +86 15721570212; Email: XiaJi0420@163.com

Study Locations

• China
  • Shanghai, China
    • Changhai Hospital
    • Contact: Zhuan Liao, MD; Phone Number: 86-21-31161004; Email: drfionachien@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
normal transit constipation group; Patients with confirmed normal transit constipation.	Device: 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)	Device: 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)	Device: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the end of the sixth week of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of constipated patients who use/do not use other constipation treatment methods	Collect relevant data through daily defecation questionnaires.	At the end of the sixth week of treatment
Proportion of constipated patients who use/do not use other constipation treatment methods	Collect relevant data through daily defecation questionnaires.	at the end of the 4-week follow-up
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.	At the end of the sixth week of treatment
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.	At the end of the sixth week of treatment
Proportion of subjects with ≥3 SBMs per week and an increase of ≥1 CSBMs during at least 4 weeks of treatment compared to baseline	Collect relevant data through daily defecation questionnaires, SBM refers to spontaneous defecation without taking laxatives within 24 hours before defecation.CSBM refers to spontaneous defecation without anal obstruction and without taking laxatives within 24 hours before defecation.	At the end of the sixth week of treatment
Proportion of patients with an average increase of ≥1 CSBMs per week during the follow-up phase compared to the baseline period;	Collect relevant data through daily defecation questionnaires.	At the end of the sixth week of treatment
Proportion of patients with an average of ≥3 SBMs per week during the follow-up phase	Collect relevant data through daily defecation questionnaires.	at the end of the 4-week follow-up
Proportion of patients with a reduction of ≥1 point in total PAC-QOL and PAC-SYM scores after treatment compared to the baseline period	Collect relevant data through daily defecation questionnaires.	At the end of the sixth week of treatment
Time of first use of laxative or enema after a course of vibrating capsule treatment (6 weeks)	Collect relevant data through daily defecation questionnaires.	After the end of the sixth week of treatment
Population Distribution by Subtypes	Proportion of different subtypes in the population	After the end of the sixth week of treatment

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Collaborators: Shanghai 10th People's Hospital; Ruijin Hospital; Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Shanghai Tongji Hospital, Tongji University School of Medicine; Shanghai 6th People's Hospital; Shanghai Pudong New Area Gongli Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: May 7, 2024
• First Submitted That Met QC Criteria: May 7, 2024
• First Posted (Actual): May 10, 2024

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Chronic Functional Constipation; cohort study; Vibrating Capsule
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: ANKONYX20231212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No