Functional ConstipationNCT04671264
Efficacy and Safety of Vibrating Capsule in Patients With Functional Constipation
A study testing Sallowing VC during six weeks in people with Functional Constipation and Gastrointestinal Disease, run by Changhai Hospital at 1 site in China.
Trial summary
The safety and efficacy of vibrating capsule (VC) in promoting defecation by mechanical stimulation of the gastrointestinal walls have been elucidated in animal studies and pilot clinical studies. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Functional Constipation, Gastrointestinal Disease, Capsule Endoscopy
- What is being tested?
- Sallowing VC during six weeks
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 1 siteChina
- Study dates
- 14 Nov 2018to 30 Oct 2020
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged over 18 years and under 80 years;
- Patients who present with chronic constipation for more than 6 months and with SBM less than 3 times per week within recent 3 weeks and have at least one of the following symptoms for more than one-fourth (25%) during defecation:
- Straining;
- Lumpy or hard stools (bristol stool form (BSF scale 1~2);
- Sensation of incomplete evacuation;
- Sensation of anorectal obstruction/blockage;
Show all 9Show fewer
- Manual maneuvers to facilitate defecation. Note: The above criteria can only be applied during spontaneous defecation, including no taking of laxatives within 24 hours before defecation, etc.
- Organic diseases were not found by barium enema or colonoscopy in the past year.
- Insufficient criteria for irritable bowel syndrome.
Who cannot join
- Patients who have contraindications to gastroscopy or colonoscopy;
- Patients under 18 years or over 80 years;
- Active vomiting;
- Patients with a permanent pacemaker (e.g. implantable cardioverter-defibrillator);
- Patients with any electronic/magnetic/mechanically controlled devices (e.g. sacral nerve stimulators, bladder stimulators);
- Patients with dysphagia, odynophagia or known swallowing disorder;
Show all 21Show fewer
- Patients with known Zenker's diverticulum;
- Patients with suspected bowel obstruction or bowel perforation;
- Patients with prior bowel obstruction;
- Patients with gastroparesis or known gastric outlet obstruction;
- Patients with known Crohn's disease;
- Patients who are taking daily non-steroidal anti-inflammatory drugs (excluding prophylactic doses of aspirin) for more than six months;
- Patients who have received abdominopelvic radiotherapy treatment;
- Patients with a history of GI tract surgery (Billroth I, Billroth II, Oesophagectomy, gastrectomy or bariatric procedure);
- Patients who are pregnant or lactating;
- Patients with altered mental status that would limit their ability to swallow;
- Patients with allergy to conscious sedation, polyethylene glycol or metoclopramide;
- Patients unwilling to swallow the capsule;
- Patients with known dementia affecting ability to consent;
- Patients who have warning signs in recent years including abnormal weight loss(>10% in recent 3 month), bloody stool (except hemorrhoids), infection, etc.;
- Other inappropriate situations determined by physicians.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Vibrating Capsule in the Treatment of Functional Constipation: a Multicenter, Double-blind, Randomized, Placebo-controlled Clinical Study
The safety and efficacy of vibrating capsule (VC) in promoting defecation by mechanical stimulation of the gastrointestinal walls have been elucidated in animal studies and pilot clinical studies. Our study aimed to explore the clinical application of a newly developed smartphone-controlled multi-mode VC in the treatment of functional constipation (FC) on multicentres.
Patients referred to gastroenterology outpatient of Changhai Hospital with FC and met the eligible criteria for more than 6 months and with spontaneous complete bowel movement (SCBM) less than 3 times per week within recent 3 weeks were eligible for this study. The study was discussed with patients who satisfied the enrolment criteria and provided written informed consents.
Read the detailed description
This study was a multicentred, double-blind, placebo-controlled clinical trial to assess the safety and the effecacy of a newly developed gastrointestinal vibrating capsule (VC) in treating patients with functional constipation (FC). The whole process included two weeks run-in period, six weeks double-blind, placebo-controlled treatment period, and a follow-up period until the discharge of all swallowed capsules. During treatment period, patients were required to swallow one capsule every three to four days and a total of twelve capsules.
For each patient, a face to face follow-up was required for at least 6 times, once every two weeks through the whole study.
Run-in period (Visit 1) Face to face consultation in gastroenterology outpatient clinic and sign of written informed consents; Barium enema or colonoscopy (no re-examination is needed if the patient has undergone barium enema or total colonoscopy within a year); Distribution of bisacodyl tablets and diary cards; Perform the following examinations: vital signs, physical examination and laboratory examination; Eligibility evaluation based on the entry/discharge criteria; Record of past medical history, concomitant diseases and medication; Collection of the baseline characteristics of the enrolled patients including age, sex, duration of constipation, mean SCBMs, spontaneous bowel movements (SBMs), BMs, frequency of bisacodyl tablets taken and Bristol Score.
Treatment period Visit 2： Randomization; Patients were asked to fill in PAC-SYM, PAC-QOL and Comprehensive Evaluation Questionnaire; Record of vital signs and physical examination; Distribution of bisacodyl tablets, capsule retrieving bags and VCs; Instruct patients how to use the control board and start the vibration of VCs; Recycle of bisacodine tablets; Distribution and collection of diary cards; Record of adverse events, concomitant diseases and medication. Visit 3, Visit 4： Patients were asked to fill in PAC-SYM, PAC-QOL and Comprehensive Evaluation Questionnaire; Record of vital signs and physical examination; Recheck fecal routine and occult blood examination; Distribution of bisacodyl tablets, capsule retrieving bags and VCs; Recycle of bisacodyl tablets and VCs; Distribution and collection of diary cards; Record of adverse events, concomitant diseases and medication. Visit 5： Patients were asked to fill in PAC-SYM, PAC-QOL and Comprehensive Evaluation Questionnaire; Record of vital signs and physical examination; ECG; Blood routine/blood biochemistry/urine routine; Fecal routine and occult blood; Recycle of bisacodyl tablets and VCs; Distribution and collection of diary cards; Distribution of capsule retrieving bags; Record of adverse events, concomitant diseases and medication.
Follow-up period (Visit6):
Determine the discharge of all capsules; Recycle of capsules; Collection of diary cards; During the follow-up period, once the capsule was discharged the follow-up would be ended. If the capsules were still in the body, the patients must continue the follow-up until the capsules were all discharged.
The primary endpoint was the proportion of patients with SBM increased more than 1 time during treatment period. Secondary endpoints including mean SCBM , SBM , bowel movement (BM) and their improvements , Bristol Score, capsule evacuation time and satisfaction level. Patients were continuously monitored for adverse events (AE) at baseline and at each visit. Satisfaction level were evaluated based on Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL) and Patient Assessment of Constipation Symptom (PAC-SYM) at each visit.
- Being tested
- Sallowing VC during six weeks
- Keywords
- Vibrating capsule, Functional Constipation, Spontaneous Bowel Movement, Clinical Trial
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sallowing VC during six weeksDevice
Also called Performing and reporting colonoscopy, Having laboratory examination, Filling diary cards, Evaluating the satisfaction
follow-up was required for at least 6 times, once every two weeks through the whole study.
For patients who had no colonoscopy examination within a year, colonoscopy was a must to exclude organic diseases.
These included blood routine, blood biochemistry, urine routine, fecal routine, fecal occult blood, thyroid stimulating hormone (TSH), blood pregnancy test and ECG examination. Patients should finish all the examination in the run-in period and at the end of treatment period.
Dairy cards were designed mainly for the record of the daily defecation of patients and filled out by the enrolled patients, and the content included date, whether the patients swallow capsules (time), whether the patients discharge capsules (time), defecation, defecation time, degree of defecation exertion(0~4), BSF scale, complete or incomplete defecation, whether the patient had the sense of anal obstruction, whether manual assistance was applied, and whether first-aid medicine was used (bisacodyl).
| Study group | Role | What they receive |
|---|---|---|
| VC group | Experimental | Vibrating capsule (VC) was proposed and applied for the patent by professor Liao Zhuan from Changhai Hospital, developed and manufactured by the Ankon Medical Technology Co., Ltd. The system consisted of a vibrating capsule and an external configuration device (ECD). It's 26.7 mm in length, 11.8 mm in diameter and 4.5 + 0.5 g in weight.
Each VC has its own semiconductor chip with serial number in order to be recognized and controlled by ECD. VC can be stopped by ECD or mobile-phone application. There was a bidirectional radio frequency communication signal between VC and ECD. In addition, an application (APP) named VCP can be connected to ECD through smart phone to select mode and debug specific parameters for VC. The capsule can be activated by ECD, and then the vibration mode can be controlled by a configurator or an smartphone application. Receives: Device: Sallowing VC during six weeks |
| Control group | Placebo comparator | The Intervention of control group were similar to VC group except the capsule function. Sham capsule we used in control group which had no function of vibrating. Receives: Device: Sallowing VC during six weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with the increasing of SCBMs during treatment period≥1
Based on diary card, researchers knew the total times of SCBMs during treatment period. The number divided by the treatment days and multiplied by 7 were the mean SCBMs per week in treatment period. Researcher compared the mean SCBMs per week with SCBMs in baseline period. "Spontaneous" suggested that no laxatives and enema were taken within 24 hours before defecation.
Measured: Up to 6 weeks
Secondary outcomes (8)
Increase of SCBMs from baseline to treatment period
Based on diary card, researchers knew the SCBMs per week during treatment period. Researchers compared them with SCBMs in baseline period.
Measured: Up to 6 weeks
The proportion of patients with the increasing of SCBMs ≥1 in at least 4 weeks
Based on diary card, researchers knew the SCBMs of each week. We compared them with SCBMs in baseline period.
Measured: Up to 6 weeks
Increase of SBMs from baseline to treatment period
SBM means spontaneous bowel movement.
Measured: Up to 6 weeks
Increase of PAC-QOL score from baseline to treatment period
The PAC-QOLquestionnaire contains 28 items grouped into 4 subscales (Values, 2005) covering: Worries and concerns (11 items), Physical discomfort (4 items), Psychosocial discomfort (8 items), and Satisfaction of treatment (5 items).
A 5-point Likert response scale, ranging from 0 (Not at all / none of the time) to 4 (Extremely / All of the time), is used over a 2-week run in period and 6-week treatment period.
Measured: Up to 6 weeks
The proportion of patients with the increasing of PAC-QOL score during treatment period≥1
At each visit, patients were asked to fill the PAC -QOL questionnaire. The score of PAC-QOL questionnaire in 6-week treatment period were the mean score of three times.
Measured: Up to 6 weeks
The proportion of patients with the increasing of PAC-SYM score during treatment period≥1
The Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire contained 12 items ( Frank, 1999) assigned to 3 subscales: stool symptoms, rectal symptoms, and abdominal symptoms. Items are scored on 5-point Likert scales, with scores ranging from 0 to 4 (0 = 'symptom absent', 1 = 'mild', 2 = 'moderate', 3 = 'severe' and 4 = 'very severe'). The lower the total score, the lower the symptom burden.
Measured: Up to 6 weeks
Bristol Score during treatment period
Stool consistency score using Bristol Stool Form Scale (median, range)-1 for hard lumps to 7 for watery stools.
Measured: Up to 6 weeks
Incidence of adverse events
The safety were assessed by the adverse events occured during this study.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start14 Nov 2018
- Primary completion11 May 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Functional ConstipationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Xiehe Hospital, Beijing 100000, China., Beijing Jishuitan Hospital, Tianjin Medical University General Hospital, Qilu Hospital of Shandong University, First Affiliated Hospital of Zhejiang University
- Responsible party
- Principal investigator, Zhuan Liao, Changhai Hospital
- Investigators
- Liao Zhuan, MD, Study chair, Department of Gastroenterology, Changhai Hospital, the Naval Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671264
- Sponsor's protocol ID
- Vibrating Capsule II
- Status last verified
- Dec 2020
- First submitted
- 3 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mearin F, Lacy BE, Chang L, Chey WD, Lembo AJ, Simren M, Spiller R. Bowel Disorders. Gastroenterology. 2016 Feb 18:S0016-5085(16)00222-5. doi: 10.1053/j.gastro.2016.02.031. Online ahead of print.
PubMed 27144627Suares NC, Ford AC. Prevalence of, and risk factors for, chronic idiopathic constipation in the community: systematic review and meta-analysis. Am J Gastroenterol. 2011 Sep;106(9):1582-91; quiz 1581, 1592. doi: 10.1038/ajg.2011.164. Epub 2011 May 24.
PubMed 21606976Ron Y, Halpern Z, Safadi R, Dickman R, Dekel R, Sperber AD. Safety and efficacy of the vibrating capsule, an innovative non-pharmacological treatment modality for chronic constipation. Neurogastroenterol Motil. 2015 Jan;27(1):99-104. doi: 10.1111/nmo.12485. Epub 2014 Dec 6.
PubMed 25484196Nelson AD, Camilleri M, Acosta A, Boldingh A, Busciglio I, Burton D, Ryks M, Zinsmeister AR. A single-center, prospective, double-blind, sham-controlled, randomized study of the effect of a vibrating capsule on colonic transit in patients with chronic constipation. Neurogastroenterol Motil. 2017 Jul;29(7). doi: 10.1111/nmo.13034. Epub 2017 Feb 8.
PubMed 28177172Yu J, Qian YY, He CH, Zhu SG, Zhao AJ, Zhu QQ, Shao CW, Wang TG, Wang Y, Ding GL, Liao Z, Li ZS. Safety and Efficacy of a New Smartphone-controlled Vibrating Capsule on Defecation in Beagles. Sci Rep. 2017 Jun 6;7(1):2841. doi: 10.1038/s41598-017-02844-4.
PubMed 28588191Nee J, Sugarman MA, Ballou S, Katon J, Rangan V, Singh P, Zubiago J, Kaptchuk TJ, Lembo A. Placebo Response in Chronic Idiopathic Constipation: A Systematic Review and Meta-Analysis. Am J Gastroenterol. 2019 Dec;114(12):1838-1846. doi: 10.14309/ajg.0000000000000399.
PubMed 31592782Zhu 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 35518121
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Vibrating Capsule in the Treatment of Functional Constipation: a Multicenter, Double-blind, Randomized, Placebo-controlled Clinical Study
- ClinicalTrials.gov ID
- NCT04671264
- Acronym / sponsor ID
- Vibrating Capsule II
- Keywords
- Vibrating capsule, Functional Constipation, Spontaneous Bowel Movement, Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Beijing Xiehe Hospital, Beijing 100000, China., Beijing Jishuitan Hospital, Tianjin Medical University General Hospital, Qilu Hospital of Shandong University, First Affiliated Hospital of Zhejiang University
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 11 May 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 17 Dec 2020 (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.
The safety and efficacy of vibrating capsule (VC) in promoting defecation by mechanical stimulation of the gastrointestinal walls have been elucidated in animal studies and pilot clinical studies. Our study aimed to explore the clinical application of a newly developed smartphone-controlled multi-mode VC in the treatment of functional constipation (FC) on multicentres.
Patients referred to gastroenterology outpatient of Changhai Hospital with FC and met the eligible criteria for more than 6 months and with spontaneous complete bowel movement (SCBM) less than 3 times per week within recent 3 weeks were eligible for this study. The study was discussed with patients who satisfied the enrolment criteria and provided written informed consents.
Detailed description
This study was a multicentred, double-blind, placebo-controlled clinical trial to assess the safety and the effecacy of a newly developed gastrointestinal vibrating capsule (VC) in treating patients with functional constipation (FC). The whole process included two weeks run-in period, six weeks double-blind, placebo-controlled treatment period, and a follow-up period until the discharge of all swallowed capsules. During treatment period, patients were required to swallow one capsule every three to four days and a total of twelve capsules.
For each patient, a face to face follow-up was required for at least 6 times, once every two weeks through the whole study.
Run-in period (Visit 1) Face to face consultation in gastroenterology outpatient clinic and sign of written informed consents; Barium enema or colonoscopy (no re-examination is needed if the patient has undergone barium enema or total colonoscopy within a year); Distribution of bisacodyl tablets and diary cards; Perform the following examinations: vital signs, physical examination and laboratory examination; Eligibility evaluation based on the entry/discharge criteria; Record of past medical history, concomitant diseases and medication; Collection of the baseline characteristics of the enrolled patients including age, sex, duration of constipation, mean SCBMs, spontaneous bowel movements (SBMs), BMs, frequency of bisacodyl tablets taken and Bristol Score.
Treatment period Visit 2： Randomization; Patients were asked to fill in PAC-SYM, PAC-QOL and Comprehensive Evaluation Questionnaire; Record of vital signs and physical examination; Distribution of bisacodyl tablets, capsule retrieving bags and VCs; Instruct patients how to use the control board and start the vibration of VCs; Recycle of bisacodine tablets; Distribution and collection of diary cards; Record of adverse events, concomitant diseases and medication. Visit 3, Visit 4： Patients were asked to fill in PAC-SYM, PAC-QOL and Comprehensive Evaluation Questionnaire; Record of vital signs and physical examination; Recheck fecal routine and occult blood examination; Distribution of bisacodyl tablets, capsule retrieving bags and VCs; Recycle of bisacodyl tablets and VCs; Distribution and collection of diary cards; Record of adverse events, concomitant diseases and medication. Visit 5： Patients were asked to fill in PAC-SYM, PAC-QOL and Comprehensive Evaluation Questionnaire; Record of vital signs and physical examination; ECG; Blood routine/blood biochemistry/urine routine; Fecal routine and occult blood; Recycle of bisacodyl tablets and VCs; Distribution and collection of diary cards; Distribution of capsule retrieving bags; Record of adverse events, concomitant diseases and medication.
Follow-up period (Visit6):
Determine the discharge of all capsules; Recycle of capsules; Collection of diary cards; During the follow-up period, once the capsule was discharged the follow-up would be ended. If the capsules were still in the body, the patients must continue the follow-up until the capsules were all discharged.
The primary endpoint was the proportion of patients with SBM increased more than 1 time during treatment period. Secondary endpoints including mean SCBM , SBM , bowel movement (BM) and their improvements , Bristol Score, capsule evacuation time and satisfaction level. Patients were continuously monitored for adverse events (AE) at baseline and at each visit. Satisfaction level were evaluated based on Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL) and Patient Assessment of Constipation Symptom (PAC-SYM) at each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VC group | Experimental | Device: Sallowing VC during six weeksVibrating capsule (VC) was proposed and applied for the patent by professor Liao Zhuan from Changhai Hospital, developed and manufactured by the Ankon Medical Technology Co., Ltd. The system consisted of a vibrating capsule and an external configuration device (ECD). It's 26.7 mm in length, 11.8 mm in diameter and 4.5 + 0.5 g in weight. Each VC has its own semiconductor chip with serial number in order to be recognized and controlled by ECD. VC can be stopped by ECD or mobile-phone application. There was a bidirectional radio frequency communication signal between VC and ECD. In addition, an application (APP) named VCP can be connected to ECD through smart phone to select mode and debug specific parameters for VC. The capsule can be activated by ECD, and then the vibration mode can be controlled by a configurator or an smartphone application. |
| Control group | Placebo comparator | Device: Sallowing VC during six weeksThe Intervention of control group were similar to VC group except the capsule function. Sham capsule we used in control group which had no function of vibrating. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female patients aged over 18 years and under 80 years;
- Patients who present with chronic constipation for more than 6 months and with SBM less than 3 times per week within recent 3 weeks and have at least one of the following symptoms for more than one-fourth (25%) during defecation:
- Organic diseases were not found by barium enema or colonoscopy in the past year.
- Insufficient criteria for irritable bowel syndrome.
Key exclusion criteria (21 listed)
- Patients who have contraindications to gastroscopy or colonoscopy;
- Patients under 18 years or over 80 years;
- Active vomiting;
- Patients with a permanent pacemaker (e.g. implantable cardioverter-defibrillator);
- Patients with any electronic/magnetic/mechanically controlled devices (e.g. sacral nerve stimulators, bladder stimulators);
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 |
|---|---|---|
| Sallowing VC during six weeksAlso: Performing and reporting colonoscopy, Having laboratory examination, Filling diary cards, Evaluating the satisfactionfollow-up was required for at least 6 times, once every two weeks through the whole study. For patients who had no colonoscopy examination within a year, colonoscopy was a must to exclude organic diseases. These included blood routine, blood biochemistry, urine routine, fecal routine, fecal occult blood, thyroid stimulating hormone (TSH), blood pregnancy test and ECG examination. Patients should finish all the examination in the run-in period and at the end of treatment period. Dairy cards were designed mainly for the record of the daily defecation of patients and filled out by the enrolled patients, and the content included date, whether the patients swallow capsules (time), whether the patients discharge capsules (time), defecation, defecation time, degree of defecation exertion(0~4), BSF scale, complete or incomplete defecation, whether the patient had the sense of anal obstruction, whether manual assistance was applied, and whether first-aid medicine was used (bisacodyl). | Device | Control group, VC group |
Primary outcome
The proportion of patients with the increasing of SCBMs during treatment period≥1
Time frame: Up to 6 weeks
Based on diary card, researchers knew the total times of SCBMs during treatment period. The number divided by the treatment days and multiplied by 7 were the mean SCBMs per week in treatment period. Researcher compared the mean SCBMs per week with SCBMs in baseline period. "Spontaneous" suggested that no laxatives and enema were taken within 24 hours before defecation.
8 secondary outcomes
Increase of SCBMs from baseline to treatment period
Time frame: Up to 6 weeks
The proportion of patients with the increasing of SCBMs ≥1 in at least 4 weeks
Time frame: Up to 6 weeks
Increase of SBMs from baseline to treatment period
Time frame: Up to 6 weeks
Increase of PAC-QOL score from baseline to treatment period
Time frame: Up to 6 weeks
The proportion of patients with the increasing of PAC-QOL score during treatment period≥1
Time frame: Up to 6 weeks
The proportion of patients with the increasing of PAC-SYM score during treatment period≥1
Time frame: Up to 6 weeks
Bristol Score during treatment period
Time frame: Up to 6 weeks
Incidence of adverse events
Time frame: Up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Background: PubMed 27144627Mearin F, Lacy BE, Chang L, Chey WD, Lembo AJ, Simren M, Spiller R. Bowel Disorders. Gastroenterology. 2016 Feb 18:S0016-5085(16)00222-5. doi: 10.1053/j.gastro.2016.02.031. Online ahead of print.
- Background: PubMed 21606976Suares NC, Ford AC. Prevalence of, and risk factors for, chronic idiopathic constipation in the community: systematic review and meta-analysis. Am J Gastroenterol. 2011 Sep;106(9):1582-91; quiz 1581, 1592. doi: 10.1038/ajg.2011.164. Epub 2011 May 24.
- Background: PubMed 25484196Ron Y, Halpern Z, Safadi R, Dickman R, Dekel R, Sperber AD. Safety and efficacy of the vibrating capsule, an innovative non-pharmacological treatment modality for chronic constipation. Neurogastroenterol Motil. 2015 Jan;27(1):99-104. doi: 10.1111/nmo.12485. Epub 2014 Dec 6.
- Background: PubMed 28177172Nelson AD, Camilleri M, Acosta A, Boldingh A, Busciglio I, Burton D, Ryks M, Zinsmeister AR. A single-center, prospective, double-blind, sham-controlled, randomized study of the effect of a vibrating capsule on colonic transit in patients with chronic constipation. Neurogastroenterol Motil. 2017 Jul;29(7). doi: 10.1111/nmo.13034. Epub 2017 Feb 8.
- Background: PubMed 28588191Yu J, Qian YY, He CH, Zhu SG, Zhao AJ, Zhu QQ, Shao CW, Wang TG, Wang Y, Ding GL, Liao Z, Li ZS. Safety and Efficacy of a New Smartphone-controlled Vibrating Capsule on Defecation in Beagles. Sci Rep. 2017 Jun 6;7(1):2841. doi: 10.1038/s41598-017-02844-4.
- Background: PubMed 31592782Nee J, Sugarman MA, Ballou S, Katon J, Rangan V, Singh P, Zubiago J, Kaptchuk TJ, Lembo A. Placebo Response in Chronic Idiopathic Constipation: A Systematic Review and Meta-Analysis. Am J Gastroenterol. 2019 Dec;114(12):1838-1846. doi: 10.14309/ajg.0000000000000399.
- Derived from this study: 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.
- Individual participant dataSharing planned: No
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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.
Liao Zhuan, MD study chair
Department of Gastroenterology, Changhai Hospital, the Naval Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sallowing VC during six weeks in people with Functional Constipation and Gastrointestinal Disease, 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 9 inclusion and 21 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: finished, as of the sponsor's last update on 17 Dec 2020. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with the increasing of SCBMs during treatment period≥1 (time frame: Up to 6 weeks). 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 NCT04671264, which also lists 7 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 17 Dec 2020.