Real-World Clinical Study on the Efficacy of Vibrating Capsule (Vibrabot Capsule) for Chronic Functional Constipation (RWS-VC)

The First Affiliated Hospital of Naval Medical University

This study is a multi-center prospective cohort study, which plans to include 300 patients with chronic functional constipation to treat with Vibrabot capsules, and at the same time, include ≥300 patients receiving constipation treatment during the same period.

During the study, it is necessary to collect the patients' basic information, baseline constipation status and treatment information, capsule intake during treatment, and concomitant medication. 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 scan the two-dimensional code or search for the electronic questionnaire "Vibrabot Health" Official Account on WeChat, and 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: Treatment with Vibrating 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.

This study focuses on post-marketing clinical study for patients with functional constipation of varying severity, further evaluating the efficacy of the product in a large sample population.

Through this real-world study, to analyze the response of functional constipation patients with different severity, treatment status, capsule dosage, and combined medication to Vibrabot capsule, as well as the duration of efficacy maintenance during the follow-up period; to compare the efficacy with patients treated with drugs or other therapies during the same period, explore the possibility of curing functional constipation patients, further improve the treatment satisfaction of constipation patients, and promote the establishment and application of consensus or guidelines for the use of Vibrabot capsule in treating functional constipation.

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): 300

Contacts and Locations

• Study Contact: Name: Yangyang Qian, MD; Phone Number: +86 13818040017; Email: drfionachien@163.com
• Study Contact Backup: Name: Jiahui Zhu, MD; Phone Number: +86 18301952685; Email: jiahuizhu2685@126.com

Study Locations

• China
  • Shanghai, China
    • Changhai Hospital
    • Contact: Zhuan Liao, MD; Phone Number: 86-21-31161004; Email: liaozhuan@smmu.edu.cn

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 300 patients with chronic functional constipation to treat with Vibrabot capsules for at least 6 weeks, and ≥300 patients with constipation receiving other treatments concurrently.

Description

Inclusion Criteria:

1. Patients who can be diagnosed with functional constipation according to the Rome IV criteria.
2. Patients who consent to participate in this trial and voluntarily sign the informed consent form (ICF).

Exclusion Criteria:

1. People who are not eligible for surgery or refuse to undergo any abdominal surgery;
2. People with known or suspected gastrointestinal obstruction, stenosis, diverticulum, bleeding, malformation, and fistula.
3. People allergic to polymeric materials;
4. People implanted with cardiac pacemakers and using gastrointestinal pacemakers;
5. People with abdominal aortic aneurysms, gastrointestinal vascular lesions, ulcers, and lesions with bleeding tendencies.
6. People with dysphagia;
7. Pregnant women;
8. People with severe depression and anxiety and severe acute gastrointestinal lesions.
9. 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

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
VC group; Treatment with Vibrabot Capsule	Device: Treatment with Vibrating 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.
Other treatment group; Selecting Alternative Treatment Methods through Assessment

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
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
Proportion of patients with a reduction of ≥1 point in total Patient Assessment of Constipation Quality of Life questionnaire(PAC-QOL) scores after treatment compared to the baseline period	Collect relevant data through daily defecation questionnaires. Patient Assessment of Constipation Quality of Life questionnaire，The PAC-QoL questionnaire consists of 28 items, each with a score of 0 to 4, measuring anxiety, physical discomfort, psychosocial discomfort, and treatment satisfaction, respectively The higher the score, the worse the quality of life.	At the end of the sixth week of treatment
Proportion of patients with a reduction of ≥1 point in total Patient Assessment of Constipation Symptom (PAC-SYM) scores after treatment compared to the baseline period	Collect relevant data through daily defecation questionnaires.The PAC-SYM questionnaire consists of 12 items, each with a score of 0 to 4, quantifying stool symptoms, rectal symptoms, and abdominal symptoms. The higher the score, the more constipation symptoms will be serious.	At the end of the sixth week of treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of constipated patients (including different constipation types, occupations, age groups, BMI, gender, and baseline treatment status) responding to vibrating capsule treatment.	Collect relevant data through baseline questionnaire.	At the end of the sixth week of treatment
occupations, age groups, BMI, gender, and baseline treatment status) responding to vibrating capsule treatment.	Collect relevant data through baseline questionnaire.	at the end of the 4-week follow-up period.

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
• Investigators: Study Chair: Zhuan Liao, MD, Changhai 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): June 1, 2026

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: May 15, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Chronic Functional Constipation; Response Rate; Vibrating Capsule; Real-World Clinical Study; Complete Spontaneous Bowel Movement
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: ANKONYX2023006

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