Efficacy of Vibrating Capsule in Patients With Chronic Constipation

April 16, 2018 updated by: Zhuan Liao, Changhai Hospital
Constipated patients in the participating center from February 2017 to June 2018 (anticipated) were prospectively enrolled. Number of defecation per week，Bristol score，and Colon transmission experiment were compared with the constipated patients before treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Constipation affects the quality of life of patients, some patients abuse laxatives or repeated medical treatment, increased medical costs. At present, the main treatment of constipation is to adjust life style, medicine, psychotherapy, biofeedback and surgical treatment. However, the above methods are associated with adverse reactions, and the patient's satisfaction is still low. A new approach is needed to solve this clinical problem.

Investigators have developed a vibration capsule that can be adjusted in different modes.

Preliminary animal experiments showed that the capsule was safe and increased the number of defecation.

This study is a clinical research for patients with constipation, to explore the effect in different vibrating modes in patients with constipation and tract emptying transmission and its effectiveness.

Study Type

Interventional

Enrollment (Anticipated)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Changhai Hospital
        • Contact:
        • Sub-Investigator:
          • Jin Yu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients aged form 18 to 80
  • Clinical diagnosis of functional constipation
  • Must be able to swallow vibrating capsule

Exclusion Criteria:

  • complex history of gastrointestinal diverticula, obstruction, ulcer, bleeding, stenosis or fistula.
  • recent use of banned drugs.
  • patients who are preparing for mri.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: Sham Capsule
Patients swallowed 1 sham Vibrating capsule with water every three days，recorded his defecation time, defecation frequency and bristol score.The total capsule need to take 12.
Device: Sham Capsule
Capsules can't vibrate but look the same as Vibrating Capsule
EXPERIMENTAL: Vibration Capsule of low level
Patients swallowed 1 low level vibration Capsule Vibrating capsule with water every three days，recorded his defecation time, defecation frequency and bristol score.The total capsule need to take 12.
Device: Vibrating Capsule
Patients in this group would be treated with Vibrating Capsule
EXPERIMENTAL: Vibration Capsule of high level
Patients swallowed 1 high level vibration Capsule Vibrating capsule with water every three days，recorded his defecation time, defecation frequency and bristol score.The total capsule need to take 12.
Device: Vibrating Capsule
Patients in this group would be treated with Vibrating Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
defecation frequency
Time Frame: 8 weeks
the average weekly defecation frequency
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bristol Stool Chart
Time Frame: 8 weeks
Record the BSC of each defecation.
8 weeks
first defecation
Time Frame: 8 weeks
The time of complete defecation after taking the capsule for the first time
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2017

Primary Completion (ANTICIPATED)

June 30, 2018

Study Completion (ANTICIPATED)

June 30, 2018

Study Registration Dates

First Submitted

April 23, 2017

First Submitted That Met QC Criteria

April 16, 2018

First Posted (ACTUAL)

April 25, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 25, 2018

Last Update Submitted That Met QC Criteria

April 16, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vibrating Capsule

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We may share IPD when we finish this research

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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