The Efficacy of Long-Course Treatment Using Vibrating Capsules for Chronic Constipation

NCT06553664 | Completed DMC

• 1 other identifier: Long-Course Treatment
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center trial. It enrolled nine 18- to 85-year-old patients with chronic constipation to evaluate the efficacy of long-course treatment by using vibrating capsule (VC).

Conditions

Chronic Functional Constipation

Keywords

Chronic Functional Constipation; Vibrating Capsule; Long-Course Treatment

Outcome Measures

Primary Outcomes (1)

• The proportions of responders 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.

  at least 7 weeks

Secondary Outcomes (2)

• The proportion of patients with complete spontaneous defecation (CSBM) ≥three times per week during the treatment period.

  at least 7 weeks

• Number of mean weekly complete spontaneous bowel movements (CSBM).

  at least 7 weeks

Study Arms (1)

Trial group

EXPERIMENTAL

Subjects in the trial group took Vibrabot capsules at least 7 weeks, doses ranging from 2 to 5 capsules orally per week.

Drug: Treat with Vibrabot capsules for at least 7 weeks

Interventions

Treat with Vibrabot capsules for at least 7 weeks DRUG

Subjects in the trial group took Vibrabot capsules at least 7 weeks, doses ranging from 2 to 5 capsules orally per week.

Trial 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:

• to 85-year-old men and women.
• Patients with symptoms of constipation in the six months prior to treatment, with less than three complete spontaneous bowel movements (CSBM) per week over the last three months, along with at least one of the following symptoms in at least 25% of bowel movements: Straining during defecation; Lumpy or hard stools (Bristol stool types 1-2) in at least 25% of bowel movements; A sensation of incomplete evacuation in at least 25% of bowel movements; A sensation of anorectal obstruction/blockage in at least 25% of bowel movements; Manual maneuvers to facilitate defecation (e.g., digital evacuation, pelvic floor support) in at least 25% of bowel movements. 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.
• Patients with constipation not caused by organic disease based on medical history and previous medical records.
• Patients who agree to participate in the trial and voluntarily sign the informed consent form.

You may not qualify if:

• Patients who are not eligible for surgery or those who refuse any abdominal surgery.
• Patients with known or suspected gastrointestinal obstruction, stenosis, diverticula, bleeding, deformities, or fistulas.
• Patients allergic to polymer materials.
• Patients with cardiac pacemakers or gastrointestinal pacemakers.
• Patients with abdominal aortic aneurysm, gastrointestinal vascular diseases, ulcers, or bleeding tendencies.
• Patients with swallowing disorders.
• Patients with severe depression or anxiety, or severe acute gastrointestinal diseases.
• Patients with history of gastrointestinal surgery or surgeries altering gastrointestinal structure (excluding appendectomy) or patients who underwent gastrointestinal endoscopic submucosal dissection (ESD) in the past three months.
• Patients with severe hemorrhoids (grade 3-4 as defined by the American Society of Colon and Rectal Surgeons guidelines).
• Patients planning to undergo magnetic resonance imaging (MRI) in the near future.
• Pregnant women or planning to become pregnant.
• Any other conditions deemed unsuitable for participation by the investigators.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

XuanJiang

Beijing, Beijing Municipality, 102218, China

Location

MeSH Terms

Interventions

Coal Tar

Intervention Hierarchy (Ancestors)

Tars; Complex Mixtures

Study Officials

• Xuan Jiang, Professor

  Beijing Tsinghua Changung Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 11, 2024
• First Posted: August 14, 2024
• Study Start: July 28, 2023
• Primary Completion: October 7, 2023
• Study Completion: December 2, 2023
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

CN (1)