Clinical StudyNCT06408883
Effect of Vibration Capsule on Different Subtypes of Functional Constipation
An observational study of Clinical Study and Chronic Functional Constipation, run by Changhai Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Study, Chronic Functional Constipation
- What is being tested?
- Vibrabot capsule
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 1 Jul 2026
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Changhai hospital
Shanghai
Zhuan Liao, MD, 86-21-31161004, drfionachien@163.com
About this study
Official title: 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).
Read the 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.
- 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.
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
- Clinical Study, Chronic Functional Constipation
- Being tested
- Vibrabot capsule
- Keywords
- Vibrating Capsule, cohort study, Chronic Functional Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrabot capsuleDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| normal transit constipation group | Patients with confirmed normal transit constipation. Receives: Device: Vibrabot capsule | |
| 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) Receives: Device: Vibrabot capsule | |
| slow-transit constipation group | Patients with confirmed slow-transit constipation.(diagnosed by colon transit scintigraphy) Receives: Device: Vibrabot capsule | |
| slow-transit constipation + dyssynergic defecation | Patients with confirmed slow-transit constipation and dyssynergic defecation. Receives: Device: Vibrabot capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of the sixth week of treatment
Secondary outcomes (10)
Proportion of constipated patients who use/do not use other constipation treatment methods
Collect relevant data through daily defecation questionnaires.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After the end of the sixth week of treatment
Population Distribution by Subtypes
Proportion of different subtypes in the population
Measured: After the end of the sixth week of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Clinical StudyStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, Shanghai 10th People's Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 6th People's Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai Pudong New Area Gongli Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408883
- Sponsor's protocol ID
- ANKONYX20231212
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33263938Zhu 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.
PubMed 35518121Camilleri 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.
PubMed 18509121
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study On the Efficacy of Vibrating Capsule For Different Subtypes of Chronic Functional Constipation
- ClinicalTrials.gov ID
- NCT06408883
- Acronym / sponsor ID
- ANKONYX20231212
- Conditions
- Clinical Study, Chronic Functional Constipation
- Keywords
- Vibrating Capsule, cohort study, Chronic Functional Constipation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Ruijin Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, Shanghai 10th People's Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 6th People's Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai Pudong New Area Gongli Hospital
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| normal transit constipation group | – | Device: Vibrabot capsulePatients with confirmed normal transit constipation. |
| dyssynergic defecation group | – | Device: Vibrabot capsulePatients with confirmed dyssynergic defecation.(abnormal balloon expulsion test and/or high anal sphincter pressure and/or failure of the anorectal angle to open) |
| slow-transit constipation group | – | Device: Vibrabot capsulePatients with confirmed slow-transit constipation.(diagnosed by colon transit scintigraphy) |
| slow-transit constipation + dyssynergic defecation | – | Device: Vibrabot capsulePatients with confirmed slow-transit constipation and dyssynergic defecation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibrabot capsuleMain 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. | Device | dyssynergic defecation group, normal transit constipation group, slow-transit constipation + dyssynergic defecation, slow-transit constipation group |
Primary outcome
After treatment, whether the response rate of patients using the Vibrabot vibrating capsules alone reaches 50%.
Time frame: At the end of the sixth week of treatment
The definition of the responder is a patient with an average weekly increase of ≥1 complete spontaneous bowel movement (CSBM) compared to the baseline.
10 secondary outcomes
Proportion of constipated patients who use/do not use other constipation treatment methods
Time frame: At the end of the sixth week of treatment
Proportion of constipated patients who use/do not use other constipation treatment methods
Time frame: 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
Time frame: At the end of the sixth week of treatment
Proportion of respondents with an average of ≥3 SBMs per week during the treatment period
Time frame: 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
Time frame: 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;
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: After the end of the sixth week of treatment
Population Distribution by Subtypes
Time frame: After the end of the sixth week of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Background: PubMed 33263938Scott 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.
- Background: PubMed 35518121Zhu 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.
- Background: PubMed 18509121Camilleri 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinical Study and Chronic Functional Constipation, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yangyang Qian (+86 13818040017, drfionachien@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
After treatment, whether the response rate of patients using the Vibrabot vibrating capsules alone reaches 50%. (time frame: At the end of the sixth week of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06408883, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.