Chronic Functional ConstipationNCT06526767
Comparative Study of Different Dosages of Vibrabot Capsule in the Treatment of Chronic Functional Constipation
A study testing Vibrabot capsules twice a week, Vibrabot capsules three times a week and Vibrabot capsules five times a week in people with Chronic Functional Constipation, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial summary
This is a single-center trial that enrolls 120 18- to 85-year-old patients with mild to moderate chronic functional constipation to study the dose-response relationship of the Vibrabot capsule as well as the mechanism of action of the Vibrabot capsule. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Functional Constipation
- What is being tested?
- Vibrabot capsules twice a week, Vibrabot capsules three times a week and Vibrabot capsules five times a week
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 23 May 2024to 31 Dec 2025
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.18 to 85-year-old men and women. 2. People with moderate to severe functional constipation according to Rome IV criteria.
- The Rome IV criteria for functional constipation are as follows:
- Must include two or more of the following:
- Straining during more than one-fourth (25%) of defecations;
- Lumpy or hard stools (BSFS 1-2) more than one-fourth (25%) of defecations;
- Sensation of incomplete evacuation more than one-fourth (25%) of defecations;
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- Sensation of anorectal obstruction/blockage more than one-fourth (25%) of defecations;
- Manual maneuvers to facilitate more than one fourth (25%) of defecations (e.g., digital evacuation, support of the pelvic floor);
- Fewer than 3 spontaneous bowel movements per week;
- Loose stools are rarely present without the use of laxatives.
- Insufficient criteria for irritable bowel syndrome Criteria fulfilled for the last three months with symptom onset at least six months prior to diagnosis.
- Severity of constipation:
- Mild: The symptoms are mild and do not affect daily life. Normal BMs can be restored through overall adjustment and medication use in a short time.
- Moderate: The symptoms are between mild and severe symptoms.
- Severe: The symptoms are severe and persistent, seriously affecting work and life, and requiring medications, and medications cannot be stopped, or medications are ineffective.
- 3. People who had a colonoscopy within three years before screening and had negative results, or whose colonoscopy results are judged by the investigator as mild anomalies, but the cause of their constipation cannot be explained. If the colonoscopy report is unavailable, the study physician will determine if a colonoscopy is needed. If the subjects undergo a colonoscopy after signing the ICF, they will not enter the treatment period until their BMs return to the baseline level (which takes about 1-4 weeks).
- 4. People had colonic polyps and a polypectomy (except for endoscopic submucosal dissection (ESD)). Those with a polyp ≤1 cm can be enrolled one month after the polypectomy. Those with a polyp >1 cm can be enrolled three months after the polypectomy.
- 5. People who consent to participate in this trial, can communicate with the investigator, understand and comply with the relevant procedures and requirements during the study (including completing study questionnaires on time, being treated and visited as scheduled, and undergoing relevant examinations), and voluntarily sign the 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.
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- People with severe depression and anxiety and severe acute gastrointestinal lesions.
- People who had gastrointestinal surgery or a history of surgery that changed the structure of the gastrointestinal tract (except for appendectomy) or people who underwent gastrointestinal ESD in the past three months.
- People with severe hemorrhoids (patients with grade III-IV hemorrhoids according to the Clinical Practice Guidelines for the Management of Hemorrhoids of the American Society of Colon and Rectal Surgeons).
- People who plan to undergo MRI in the near future.
- Pregnant women or women with pregnancy plans in the next year.
- 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, 1 recruiting
- Recruiting
XuanJiang
Beijing, Beijing Municipality, 102218
Xuan Jiang, professor, 13671006525, jxa01998@btch.edu.cn
Ting Yi, physician, 13331154633, withoutsun@hotmail.com
About this study
Official title: Comparative Study of Different Dosages of Disposable Gastrointestinal Vibrating Capsule (Vibrabot Capsule) in the Treatment of Mild to Moderate Chronic Functional Constipation
This is a single-center trial that enrolls 120 18- to 85-year-old patients with mild to moderate chronic functional constipation to study the dose-response relationship of the Vibrabot capsule as well as the mechanism of action of the Vibrabot capsule.
Read the detailed description
This study was a single-center, prospective, randomized, parallel-controlled clinical trial. If a subject signs an Ethics Committee (EC)-approved study informed consent (ICF) that meets the inclusion criteria and does not meet any of the exclusion criteria, the subject is considered eligible for admission to the study. Participants with chronic functional constipation enrolled in the study completed a two-week baseline period in which they were advised to avoid taking any laxatives or other treatments for their constipation as much as possible. After the two-week basal period, all subjects were randomly assigned to the control group, trial group 1, trial group 2, and trial group 3 for the corresponding treatment.
Control group: Vibrabot capsule was taken twice a week, one pill/time (on Monday and Thursday), for six weeks; Trial group 1: Vibrabot capsule administration and dosage were three times a week, one pill/time (Monday, Wednesday, and Friday) for six consecutive weeks; Trial group 2: Vibrabot capsule administration and dosage five times a week, one pill/time (Monday, Tuesday, Wednesday, Friday, and Saturday), for six weeks; Trial group 3: Vibrabot capsule administration and dosage for the first two weeks, five times a week, one pill/time (Monday, Tuesday, Wednesday, Friday, and Saturday); for the middle two weeks, three times a week, one pill/time (Monday, Wednesday, and Friday); and for the last two weeks, two times a week, one pill/time (Monday and Thursday).
The subjects who receive Vibrabot capsules will undergo a neurotransmitter test and a fecal flora test before and after the treatment. After completion of treatment, subjects in each group entered a follow-up period, which was observed until the patient regained symptoms of constipation, i.e., when laxatives or other bowel-promoting treatments were used. If the subject never recovered from constipation, a minimum of 8 weeks of questionnaire completion was required, depending on the patient's compliance status. During the study period, the subjects are required to keep an e-diary recording daily bowel movements (BMs), medication intake, and discomforts, and complete the Patient Assessment of Constipation Symptoms (PAC-SYM) and the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaires every two weeks. This study consists of a screening/baseline period, a treatment period, and a follow-up period. During the study, subjects are required not to change their diet and lifestyle.
Subjects are not expected to change their diet or lifestyle during the study. If the subject has not had a bowel movement for three or more consecutive days, the subject is allowed to use another method of defecation to assist with defecation. Subjects are required to avoid antibiotics, probiotics, prebiotics, and proton pump inhibitors throughout their participation in the study.
- Conditions
- Chronic Functional Constipation
- Being tested
- Vibrabot capsules twice a week, Vibrabot capsules three times a week, Vibrabot capsules five times a week, Vibrabot capsules loading dose
- Keywords
- Chronic Functional Constipation, Vibrating Capsule, Dose-response Relationship, Mechanism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrabot capsules twice a weekDevice
Subjects in control group took Vibrabot capsules twice a week, one pill/time (on Monday and Thursday), for six weeks.
Vibrabot capsules three times a weekDevice
Subjects in trial group 1 took Vibrabot capsules three times a week, one pill/time (Monday, Wednesday, and Friday) for six consecutive weeks.
Vibrabot capsules five times a weekDevice
Subjects in trial group 2 took Vibrabot capsules five times a week, one pill/time (Monday, Tuesday, Wednesday, Friday, and Saturday), for six weeks.
Vibrabot capsules loading doseDevice
Subjects in trial group 3 took Vibrabot capsules one pill/time, five times a week (Monday, Tuesday, Wednesday, Friday, and Saturday) during the first two weeks, three times a week (Monday, Wednesday, and Friday) during the middle two weeks, and two times a week (Monday and Thursday) during the last two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | Subjects in control group took Vibrabot capsules twice a week, one pill/time (on Monday and Thursday), for six weeks. Receives: Device: Vibrabot capsules twice a week |
| Trial group 1 | Experimental | Subjects in trial group 1 took Vibrabot capsules three times a week, one pill/time (Monday, Wednesday, and Friday) for six consecutive weeks. Receives: Device: Vibrabot capsules three times a week |
| Trial group 2 | Experimental | Subjects in trial group 2 took Vibrabot capsules five times a week, one pill/time (Monday, Tuesday, Wednesday, Friday, and Saturday), for six weeks. Receives: Device: Vibrabot capsules five times a week |
| Trial group 3 | Experimental | Subjects in trial group 3 took Vibrabot capsules one pill/time, five times a week (Monday, Tuesday, Wednesday, Friday, and Saturday) during the first two weeks, three times a week (Monday, Wednesday, and Friday) during the middle two weeks, and two times a week (Monday and Thursday) during the last two weeks. Receives: Device: Vibrabot capsules loading dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportions of responders to the four therapies during the treatment period.
Responders are the subjects with an average increase of ≥1 complete spontaneous bowel movements (CSBMs) per week during the treatment period compared to the baseline period.
Measured: 6 weeks
Secondary outcomes (7)
The changes in neurotransmitter levels before and after treatment with Vibrabot capsules.
Patients should have blood samples collected before and after treatment for the measurement of neurotransmitters such as Substance P (SP), Serotonin (5-HT), Nitric Oxide (NO), and Gamma-Aminobutyric Acid (GABA).
Measured: 6 weeks of treatment.
The changes in fecal microbiota before and after treatment with Vibrabot capsules.
Patients should collect fecal specimens before and after treatment for the analysis of fecal microbiota species and abundance through 16S rRNA sequencing.
Measured: 6 weeks of treatment.
Assessment of quality of life among different treatment groups.
The PAC-QOL questionnaire is the most validated tool for measuring the quality of life of patients with constipation. It consists of 28 self-reported items investigating the effects of constipation on the patient's quality of life in the past 2 weeks. The PAC-QOL questionnaire is subcategorized into 4 items on physical discomfort, 8 items on psychosocial discomfort, 5 items on treatment satisfaction, and finally 11 items on worries and discomfort. The response choice is on a Likert scale from 0 to 4. Higher scores mean higher negative effects on quality of life.
Measured: Every 2 weeks during the treatment period and the follow-up period, up to 14 weeks.
Assessment of the severity of patient-reported symptoms among different treatment groups.
The PAC-SYM questionnaire has emerged as an important tool for assessing the severity of patient-reported symptoms of constipation. The 12-item questionnaire is divided into three symptom subscales: abdominal (four items); rectal (three items); and stool (five items). 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'). A mean total score in the range of 0-4 is generated by dividing the total score by the number of questions completed; the lower the total score, the lower the symptom.
Measured: Every 2 weeks during the treatment period and the follow-up period, up to 14 weeks.
The proportions of responders to the four therapies during the follow-up period.
Responders are the subjects with an average increase of ≥1 complete spontaneous bowel movements (CSBMs) per week during the follow-up period compared to the baseline period.
Measured: 8 weeks of follow-up.
The proportion of patients with complete spontaneous defecation (CSBM) ≥three times per week during the treatment period;
Evaluating the proportion of patients with complete spontaneous defecation (CSBM) ≥three times per week among different treatment groups during the treatment period.
Measured: 6 weeks of treatment.
The proportion of patients with complete spontaneous defecation (CSBM) ≥three times per week during the follow-up period.
Evaluating the proportion of patients with complete spontaneous defecation (CSBM) ≥three times per week among different treatment groups during the follow-up period.
Measured: 8 weeks of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start23 May 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Functional ConstipationStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung 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
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jiangxuan, Beijing Tsinghua Chang Gung Hospital
- Investigators
- Xuan Jiang, Professor, Principal investigator, Beijing Tsinghua Changung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526767
- Sponsor's protocol ID
- 23648-4-01
- Status last verified
- Jul 2024
- First submitted
- 14 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Different Dosages of Disposable Gastrointestinal Vibrating Capsule (Vibrabot Capsule) in the Treatment of Mild to Moderate Chronic Functional Constipation
- ClinicalTrials.gov ID
- NCT06526767
- Acronym / sponsor ID
- 23648-4-01
- Conditions
- Chronic Functional Constipation
- Keywords
- Chronic Functional Constipation, Vibrating Capsule, Dose-response Relationship, Mechanism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 23 May 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 Jul 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 is a single-center trial that enrolls 120 18- to 85-year-old patients with mild to moderate chronic functional constipation to study the dose-response relationship of the Vibrabot capsule as well as the mechanism of action of the Vibrabot capsule.
Detailed description
This study was a single-center, prospective, randomized, parallel-controlled clinical trial. If a subject signs an Ethics Committee (EC)-approved study informed consent (ICF) that meets the inclusion criteria and does not meet any of the exclusion criteria, the subject is considered eligible for admission to the study. Participants with chronic functional constipation enrolled in the study completed a two-week baseline period in which they were advised to avoid taking any laxatives or other treatments for their constipation as much as possible. After the two-week basal period, all subjects were randomly assigned to the control group, trial group 1, trial group 2, and trial group 3 for the corresponding treatment.
Control group: Vibrabot capsule was taken twice a week, one pill/time (on Monday and Thursday), for six weeks; Trial group 1: Vibrabot capsule administration and dosage were three times a week, one pill/time (Monday, Wednesday, and Friday) for six consecutive weeks; Trial group 2: Vibrabot capsule administration and dosage five times a week, one pill/time (Monday, Tuesday, Wednesday, Friday, and Saturday), for six weeks; Trial group 3: Vibrabot capsule administration and dosage for the first two weeks, five times a week, one pill/time (Monday, Tuesday, Wednesday, Friday, and Saturday); for the middle two weeks, three times a week, one pill/time (Monday, Wednesday, and Friday); and for the last two weeks, two times a week, one pill/time (Monday and Thursday).
The subjects who receive Vibrabot capsules will undergo a neurotransmitter test and a fecal flora test before and after the treatment. After completion of treatment, subjects in each group entered a follow-up period, which was observed until the patient regained symptoms of constipation, i.e., when laxatives or other bowel-promoting treatments were used. If the subject never recovered from constipation, a minimum of 8 weeks of questionnaire completion was required, depending on the patient's compliance status. During the study period, the subjects are required to keep an e-diary recording daily bowel movements (BMs), medication intake, and discomforts, and complete the Patient Assessment of Constipation Symptoms (PAC-SYM) and the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaires every two weeks. This study consists of a screening/baseline period, a treatment period, and a follow-up period. During the study, subjects are required not to change their diet and lifestyle.
Subjects are not expected to change their diet or lifestyle during the study. If the subject has not had a bowel movement for three or more consecutive days, the subject is allowed to use another method of defecation to assist with defecation. Subjects are required to avoid antibiotics, probiotics, prebiotics, and proton pump inhibitors throughout their participation in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Device: Vibrabot capsules twice a weekSubjects in control group took Vibrabot capsules twice a week, one pill/time (on Monday and Thursday), for six weeks. |
| Trial group 1 | Experimental | Device: Vibrabot capsules three times a weekSubjects in trial group 1 took Vibrabot capsules three times a week, one pill/time (Monday, Wednesday, and Friday) for six consecutive weeks. |
| Trial group 2 | Experimental | Device: Vibrabot capsules five times a weekSubjects in trial group 2 took Vibrabot capsules five times a week, one pill/time (Monday, Tuesday, Wednesday, Friday, and Saturday), for six weeks. |
| Trial group 3 | Experimental | Device: Vibrabot capsules loading doseSubjects in trial group 3 took Vibrabot capsules one pill/time, five times a week (Monday, Tuesday, Wednesday, Friday, and Saturday) during the first two weeks, three times a week (Monday, Wednesday, and Friday) during the middle two weeks, and two times a week (Monday and Thursday) during the last two weeks. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 1.18 to 85-year-old men and women. 2. People with moderate to severe functional constipation according to Rome IV criteria.
- Must include two or more of the following:
- Loose stools are rarely present without the use of laxatives.
- Insufficient criteria for irritable bowel syndrome Criteria fulfilled for the last three months with symptom onset at least six months prior to diagnosis.
- Mild: The symptoms are mild and do not affect daily life. Normal BMs can be restored through overall adjustment and medication use in a short time.
Key exclusion criteria (12 listed)
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 capsules twice a weekSubjects in control group took Vibrabot capsules twice a week, one pill/time (on Monday and Thursday), for six weeks. | Device | Control group |
| Vibrabot capsules three times a weekSubjects in trial group 1 took Vibrabot capsules three times a week, one pill/time (Monday, Wednesday, and Friday) for six consecutive weeks. | Device | Trial group 1 |
| Vibrabot capsules five times a weekSubjects in trial group 2 took Vibrabot capsules five times a week, one pill/time (Monday, Tuesday, Wednesday, Friday, and Saturday), for six weeks. | Device | Trial group 2 |
| Vibrabot capsules loading doseSubjects in trial group 3 took Vibrabot capsules one pill/time, five times a week (Monday, Tuesday, Wednesday, Friday, and Saturday) during the first two weeks, three times a week (Monday, Wednesday, and Friday) during the middle two weeks, and two times a week (Monday and Thursday) during the last two weeks. | Device | Trial group 3 |
Primary outcome
The proportions of responders to the four therapies during the treatment period.
Time frame: 6 weeks
Responders are the subjects with an average increase of ≥1 complete spontaneous bowel movements (CSBMs) per week during the treatment period compared to the baseline period.
7 secondary outcomes
The changes in neurotransmitter levels before and after treatment with Vibrabot capsules.
Time frame: 6 weeks of treatment.
The changes in fecal microbiota before and after treatment with Vibrabot capsules.
Time frame: 6 weeks of treatment.
Assessment of quality of life among different treatment groups.
Time frame: Every 2 weeks during the treatment period and the follow-up period, up to 14 weeks.
Assessment of the severity of patient-reported symptoms among different treatment groups.
Time frame: Every 2 weeks during the treatment period and the follow-up period, up to 14 weeks.
The proportions of responders to the four therapies during the follow-up period.
Time frame: 8 weeks of follow-up.
The proportion of patients with complete spontaneous defecation (CSBM) ≥three times per week during the treatment period;
Time frame: 6 weeks of treatment.
The proportion of patients with complete spontaneous defecation (CSBM) ≥three times per week during the follow-up period.
Time frame: 8 weeks of follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- 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.
Xuan Jiang, Professor principal investigator
Beijing Tsinghua Changung Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrabot capsules twice a week, Vibrabot capsules three times a week and Vibrabot capsules five times a week in people with Chronic Functional Constipation, run by Beijing Tsinghua Chang Gung 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 18 inclusion and 12 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 30 Jul 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 Xuan Jiang, Professor (13671006525, jxa01998@btch.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportions of responders to the four therapies during the treatment period. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2024.