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

The Efficacy of Long-Course Treatment Using Disposable Gastrointestinal Vibrating Capsule (Vibrabot Capsule) for Chronic Constipation

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).

Study Overview

• Status: Completed
• Conditions: Chronic Functional Constipation
• Intervention / Treatment: Drug: Treat with Vibrabot capsules for at least 7 weeks

Detailed Description

This study was a single-center prospective, single-arm exploratory clinical trial. If a subject signs an Ethics Committee (EC)-approved study informed consent (ICF) that meets the inclusion criteria and does not meet any of the exclusion criteria, the subject is considered eligible for admission to the study.

After completing a baseline questionnaire on bowel movements over the most recent 2 weeks, participants took VC at least 7 weeks, doses ranging from 2 to 5 capsules orally per week. After completion of treatment, subjects entered a follow-up period for at least 8 weeks. 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.

Subjects are not expected to change their diet or lifestyle during the study. If the subject has not had a bowel movement for three or more consecutive days, the subject is allowed to use another method of defecation to assist with defecation. Subjects are required to avoid antibiotics, probiotics, prebiotics, and proton pump inhibitors throughout their participation in the study.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 102218
      • XuanJiang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trial group; 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; Subjects in the trial group took Vibrabot capsules at least 7 weeks, doses ranging from 2 to 5 capsules orally per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients with complete spontaneous defecation (CSBM) ≥three times per week during the treatment period.	Evaluating 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).	The average number of complete spontaneous bowel movements per week for each patient during the treatment period.	at least 7 weeks

Collaborators and Investigators

• Sponsor: Beijing Tsinghua Chang Gung Hospital
• Investigators: Principal Investigator: Xuan Jiang, Professor, Beijing Tsinghua Changung Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2023
• Primary Completion (Actual): October 7, 2023
• Study Completion (Actual): December 2, 2023

Study Registration Dates

• First Submitted: August 11, 2024
• First Submitted That Met QC Criteria: August 13, 2024
• First Posted (Actual): August 14, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 15, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Chronic Functional Constipation; Vibrating Capsule; Long-Course Treatment
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: Long-Course Treatment

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No