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

NCT06364111 | Unknown DMC

• 1 other identifier: Vibrabot Capsule
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Functional Constipation

Outcome Measures

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.

  18 months

Secondary Outcomes (4)

• Evaluation of intestinal motility

  18 months

• Assessment of neurotransmitters in peripheral blood

  18 months

• Assessment of changes in intestinal flora

  18 months

• Evaluation of the treatment cycle of Vibrabot Capsules

  18 months

Study Arms (3)

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.

Device: Vibrabot capsule

Trial group 2

EXPERIMENTAL

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

Device: Vibrabot capsule

Control group

EXPERIMENTAL

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

Drug: polyethylene glycol

Interventions

Vibrabot capsule DEVICE

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.

Trial group 1; Trial group 2

polyethylene glycol DRUG

Subjects in the control group received polyethylene glycol for 6 weeks

Control group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

XuanJiang

Beijing, Beijing Municipality, 102218, China

RECRUITING

MeSH Terms

Interventions

Polyethylene Glycols

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Xuan Jiang, Professor

  Beijing Tsinghua Changung Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuan Jiang, Professor

CONTACT

13671006525; jxa01998@btch.edu.cn

Jinzhe Liu, Physician

CONTACT

18810831618; ljza02528@btch.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: April 15, 2024
• Study Start: January 8, 2024
• Primary Completion: June 14, 2025
• Study Completion: August 30, 2025
• Last Updated: April 15, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)