Chronic Functional ConstipationNCT06364111
Comparative Study on the Efficacy of Vibrabot Capsule and Polyethylene Glycol for Chronic Functional Constipation
A study testing Vibrabot capsule and polyethylene glycol 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 20 18 to 85-year-old patients with moderate to severe FC to study the efficacy of Vibrabot capsule (dosage: 5 capsules/week) and polyethylene glycol, 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 capsule and polyethylene glycol
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2024to 30 Aug 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
- People with moderate to severe functional constipation according to Rome IV criteria.
- People who agree to use appropriate medical methods of contraception from the time they sign the ICF until the end of the treatment period (excluding women in a medical sterilization status).
- People who had a colonoscopy within three years before screening and negative results, or their 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.
- 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.
- People who consent to participate in this trial and can communicate with the investigator and can 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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- Pregnant women or women with pregnancy plans in the next year.
- 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.
- 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
Jinzhe Liu, physician, 18810831618, ljza02528@btch.edu.cn
About this study
Official title: Comparative Study on the Efficacy of Disposable Gastrointestinal Vibrating Capsule (Vibrabot Capsule) and Polyethylene Glycol for Chronic Functional Constipation
This is a single-center trial that enrolls 20 18 to 85-year-old patients with moderate to severe FC to study the efficacy of Vibrabot capsule (dosage: 5 capsules/week) and polyethylene glycol, as well as the mechanism of action of the Vibrabot capsule.
Read the detailed description
This study is a prospective, parallel controlled clinical trial. Subjects are considered eligible for this study if they meet the inclusion criteria and do not meet any of the exclusion criteria. They must sign an Ethics Committee (EC)-approved Informed Consent Form (ICF) and be randomly assigned to trial group 1, trial group 2 and control group for the respective treatment.
Subjects in Trial Group 1 received polyethylene glycol combined with Vibrabot capsules for 2 weeks and then Vibrabot capsules for 4 weeks; Subjects in Trial Group 2 received Vibrabot capsules for 12 consecutive weeks; Subjects in the control group received polyethylene glycol for 6 weeks, and subjects with poor efficacy could voluntarily choose to continue to receive Vibrabot capsules for 6 weeks. During the treatment period, the dosage of Vibrabot capsule is 1 capsule/time, 5 times/week, and that of polyethylene glycol is 10g/time, twice/day. The subjects who receive Vibrabot capsules will undergo a colonic transit study, a radionuclide imaging-based gastrointestinal transit assessment, an anorectal manometry, 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. The washout or follow-up period will end once the subject uses rescue medication. If subjects have no BM for three or more consecutive days, they are permitted to take bisacodyl as rescue medication. If they cannot tolerate bisacodyl, an enema may be used instead. They should avoid antibiotics, probiotics, prebiotics, and proton pump inhibitors throughout their participation in the study.
- Conditions
- Chronic Functional Constipation
- Being tested
- Vibrabot capsule, polyethylene glycol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrabot capsuleDevice
Subjects in Trial Group 1 received polyethylene glycol combined with Vibrabot capsules for 2 weeks and then Vibrabot capsules for 4 weeks; Subjects in Trial Group 2 received Vibrabot capsules for 12 consecutive weeks.
polyethylene glycolDrug
Subjects in the control group received polyethylene glycol for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Trial group 1 | Experimental | Subjects in Trial Group 1 received polyethylene glycol combined with Vibrabot capsules for 2 weeks and then Vibrabot capsules for 4 weeks. Receives: Device: Vibrabot capsule |
| Trial group 2 | Experimental | Subjects in Trial Group 2 received Vibrabot capsules for 12 consecutive weeks. Receives: Device: Vibrabot capsule |
| Control group | Experimental | subjects in the control group received polyethylene glycol for 6 weeks. Receives: Drug: polyethylene glycol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportions of responders to the three 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: 18 months
Secondary outcomes (4)
Evaluation of intestinal motility
Comparison of colonic transit time (h) before and after treatment with Vibrabot capsules.
Measured: 18 months
Assessment of neurotransmitters in peripheral blood
Changes in peripheral blood levels (ng/ml) of five neurotransmitters, NO, VIP, 5-HT, SP, and GABA, before and after treatment with Vibrabot capsules.
Measured: 18 months
Assessment of changes in intestinal flora
Assessment of changes in intestinal flora.
Measured: 18 months
Evaluation of the treatment cycle of Vibrabot Capsules
Evaluate the percentage of responders to 6 weeks of treatment versus 12 weeks of treatment with Vibrabot capsules.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start8 Jan 2024
- Primary completion14 Jun 2025 (estimated)
- Study completion30 Aug 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xuan Jiang, Professor, Principal investigator, Beijing Tsinghua Changung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364111
- Sponsor's protocol ID
- Vibrabot Capsule
- Status last verified
- Dec 2023
- First submitted
- 12 Dec 2023
- Last updated
- 15 Apr 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 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on the Efficacy of Disposable Gastrointestinal Vibrating Capsule (Vibrabot Capsule) and Polyethylene Glycol for Chronic Functional Constipation
- ClinicalTrials.gov ID
- NCT06364111
- Acronym / sponsor ID
- Vibrabot Capsule
- Conditions
- Chronic Functional Constipation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 14 Jun 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 15 Apr 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 20 18 to 85-year-old patients with moderate to severe FC to study the efficacy of Vibrabot capsule (dosage: 5 capsules/week) and polyethylene glycol, as well as the mechanism of action of the Vibrabot capsule.
Detailed description
This study is a prospective, parallel controlled clinical trial. Subjects are considered eligible for this study if they meet the inclusion criteria and do not meet any of the exclusion criteria. They must sign an Ethics Committee (EC)-approved Informed Consent Form (ICF) and be randomly assigned to trial group 1, trial group 2 and control group for the respective treatment.
Subjects in Trial Group 1 received polyethylene glycol combined with Vibrabot capsules for 2 weeks and then Vibrabot capsules for 4 weeks; Subjects in Trial Group 2 received Vibrabot capsules for 12 consecutive weeks; Subjects in the control group received polyethylene glycol for 6 weeks, and subjects with poor efficacy could voluntarily choose to continue to receive Vibrabot capsules for 6 weeks. During the treatment period, the dosage of Vibrabot capsule is 1 capsule/time, 5 times/week, and that of polyethylene glycol is 10g/time, twice/day. The subjects who receive Vibrabot capsules will undergo a colonic transit study, a radionuclide imaging-based gastrointestinal transit assessment, an anorectal manometry, 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. The washout or follow-up period will end once the subject uses rescue medication. If subjects have no BM for three or more consecutive days, they are permitted to take bisacodyl as rescue medication. If they cannot tolerate bisacodyl, an enema may be used instead. They should 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Trial group 1 | Experimental | Device: Vibrabot capsuleSubjects in Trial Group 1 received polyethylene glycol combined with Vibrabot capsules for 2 weeks and then Vibrabot capsules for 4 weeks. |
| Trial group 2 | Experimental | Device: Vibrabot capsuleSubjects in Trial Group 2 received Vibrabot capsules for 12 consecutive weeks. |
| Control group | Experimental | Drug: polyethylene glycolsubjects in the control group received polyethylene glycol for 6 weeks. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- People with moderate to severe functional constipation according to Rome IV criteria.
- People who agree to use appropriate medical methods of contraception from the time they sign the ICF until the end of the treatment period (excluding women in a medical sterilization status).
- People who had a colonoscopy within three years before screening and negative results, or their 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.
- 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.
- People who consent to participate in this trial and can communicate with the investigator and can 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.
Key exclusion criteria (12 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.
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 capsuleSubjects in Trial Group 1 received polyethylene glycol combined with Vibrabot capsules for 2 weeks and then Vibrabot capsules for 4 weeks; Subjects in Trial Group 2 received Vibrabot capsules for 12 consecutive weeks. | Device | Trial group 1, Trial group 2 |
| polyethylene glycolSubjects in the control group received polyethylene glycol for 6 weeks | Drug | Control group |
Primary outcome
The proportions of responders to the three therapies during the treatment period.
Time frame: 18 months
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.
4 secondary outcomes
Evaluation of intestinal motility
Time frame: 18 months
Assessment of neurotransmitters in peripheral blood
Time frame: 18 months
Assessment of changes in intestinal flora
Time frame: 18 months
Evaluation of the treatment cycle of Vibrabot Capsules
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 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 capsule and polyethylene glycol 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 5 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 15 Apr 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 three therapies during the treatment period. (time frame: 18 months). 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 15 Apr 2024.