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RecruitingNCT06364111Updated Apr 15, 2024

Comparative Study on the Efficacy of Vibrabot Capsule and Polyethylene Glycol for Chronic Functional Constipation

An interventional study of Vibrabot capsule and polyethylene glycol in Chronic Functional Constipation, sponsored by Beijing Tsinghua Chang Gung Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-04-15.

Sponsored by Beijing Tsinghua Chang Gung Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Jan 2024; still recruiting 2 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Chronic Functional Constipation

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03

In context

Constipation

1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.

This study's planned enrollment of 45 is below the median of 80 across 850 interventional studies indexed under Constipation.

Browse Constipation studies →

Lead sponsor

Beijing Tsinghua Chang Gung Hospital is the lead sponsor of 96 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. People with moderate to severe functional constipation according to Rome IV criteria.
  2. 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).
  3. 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.
  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 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.

Exclusion criteria

Exclusion Criteria:

  1. People who are not eligible for surgery or refuse to undergo any abdominal surgery.
  2. People with known or suspected gastrointestinal obstruction, stenosis, diverticulum, bleeding, malformation, and fistula.
  3. People allergic to polymeric materials.
  4. People implanted with cardiac pacemakers and using gastrointestinal pacemakers.
  5. People with abdominal aortic aneurysms, gastrointestinal vascular lesions, ulcers, and lesions with bleeding tendencies.
  6. People with dysphagia.
  7. Pregnant women or women with pregnancy plans in the next year.
  8. People with severe depression and anxiety and severe acute gastrointestinal lesions.
  9. 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.
  10. 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).
  11. People who plan to undergo MRI in the near future.
  12. People with other conditions, so the investigator considers them not eligible for this study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    Trial group 1

    Subjects in Trial Group 1 received polyethylene glycol combined with Vibrabot capsules for 2 weeks and then Vibrabot capsules for 4 weeks.

    Device: Vibrabot capsule

  • Experimental
    Trial group 2

    Subjects in Trial Group 2 received Vibrabot capsules for 12 consecutive weeks.

    Device: Vibrabot capsule

  • Experimental
    Control group

    subjects in the control group received polyethylene glycol for 6 weeks.

    Drug: polyethylene glycol

Interventions

  • DeviceVibrabot capsule

    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.

  • Drugpolyethylene glycol

    Subjects in the control group received polyethylene glycol for 6 weeks

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 18 months

Secondary outcomes

  1. Evaluation of intestinal motility

    Comparison of colonic transit time (h) before and after treatment with Vibrabot capsules.

    Time frame: 18 months

  2. 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.

    Time frame: 18 months

  3. Assessment of changes in intestinal flora

    Assessment of changes in intestinal flora.

    Time frame: 18 months

  4. 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.

    Time frame: 18 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06364111
Lead sponsor
Beijing Tsinghua Chang Gung Hospital
Responsible party
Sponsor
First posted
Apr 15, 2024
Start date
Jan 8, 2024
Primary completion
Jun 14, 2025 (estimated)
Completion
Aug 30, 2025 (estimated)
Last update
Apr 15, 2024

Study contacts

Xuan Jiang, Professor
Contact
jxa01998@btch.edu.cn
13671006525
Jinzhe Liu, Physician
Contact
ljza02528@btch.edu.cn
18810831618
Xuan Jiang, Professor
principal investigator · Beijing Tsinghua Changung Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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