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

Last updated: April 8, 2024
Sponsor: Beijing Tsinghua Chang Gung Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Constipation

Treatment

polyethylene glycol

Vibrabot capsule

Clinical Study ID

NCT06364111
Vibrabot Capsule
  • Ages 18-85
  • All Genders

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.

Eligibility Criteria

Inclusion

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 timethey sign the ICF until the end of the treatment period (excluding women in a medicalsterilization 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 thecause of their constipation cannot be explained. If the colonoscopy report isunavailable, the study physician will determine if a colonoscopy is needed. If thesubjects undergo a colonoscopy after signing the ICF, they will not enter thetreatment period until their BMs return to the baseline level.
  4. People had colonic polyps and a polypectomy (except for endoscopic submucosaldissection (ESD)): Those with a polyp ≤1 cm can be enrolled one month after thepolypectomy; Those with a polyp >1 cm can be enrolled three months after thepolypectomy.
  5. People who consent to participate in this trial and can communicate with theinvestigator and can understand and comply with the relevant procedures andrequirements during the study (including completing study questionnaires on time,being treated and visited as scheduled, and undergoing relevant examinations), andvoluntarily sign the ICF.

Exclusion

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, andlesions 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 thestructure of the gastrointestinal tract (except for appendectomy) or people whounderwent gastrointestinal ESD in the past three months.
  10. People with severe hemorrhoids (patients with grade III-IV hemorrhoids according tothe Clinical Practice Guidelines for the Management of Hemorrhoids of the AmericanSociety 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 thisstudy.

Study Design

Total Participants: 45
Treatment Group(s): 2
Primary Treatment: polyethylene glycol
Phase:
Study Start date:
January 08, 2024
Estimated Completion Date:
August 30, 2025

Study 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.

Connect with a study center

  • XuanJiang

    Beijing, Beijing 102218
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.