search
Back to results

Efficacy of Vibrating Capsule in Patients With Chronic Constipation

Primary Purpose

Chronic Constipation

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Vibrating Capsule
Sham Capsule
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Constipation focused on measuring Vibrating Capsule, Efficacy and Safety, Chronic Constipation, different vibrating modes

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Changhai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Experimental

Experimental

Arm Label

Sham Capsule

Vibration Capsule of low level

Vibration Capsule of high level

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

defecation frequency
the average weekly defecation frequency

Secondary Outcome Measures

Bristol Stool Chart
Record the BSC of each defecation.
first defecation
The time of complete defecation after taking the capsule for the first time

Full Information

First Posted
April 23, 2017
Last Updated
April 16, 2018
Sponsor
Changhai Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03508076
Brief Title
Efficacy of Vibrating Capsule in Patients With Chronic Constipation
Official Title
Efficacy of Vibrating Capsule in Patients With Chronic Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Anticipated)
Study Completion Date
June 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Constipation
Keywords
Vibrating Capsule, Efficacy and Safety, Chronic Constipation, different vibrating modes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham Capsule
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Vibration Capsule of low level
Arm Type
Experimental
Arm Description
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.
Arm Title
Vibration Capsule of high level
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Vibrating Capsule
Intervention Description
Patients in this group would be treated with Vibrating Capsule
Intervention Type
Device
Intervention Name(s)
Sham Capsule
Intervention Description
Capsules can't vibrate but look the same as Vibrating Capsule
Primary Outcome Measure Information:
Title
defecation frequency
Description
the average weekly defecation frequency
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Bristol Stool Chart
Description
Record the BSC of each defecation.
Time Frame
8 weeks
Title
first defecation
Description
The time of complete defecation after taking the capsule for the first time
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Changhai Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhuan Liao, professor
Phone
13061921980
Email
liaozhuan@smmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Jin Yu

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
We may share IPD when we finish this research
Citations:
PubMed Identifier
28588191
Citation
Yu J, Qian YY, He CH, Zhu SG, Zhao AJ, Zhu QQ, Shao CW, Wang TG, Wang Y, Ding GL, Liao Z, Li ZS. Safety and Efficacy of a New Smartphone-controlled Vibrating Capsule on Defecation in Beagles. Sci Rep. 2017 Jun 6;7(1):2841. doi: 10.1038/s41598-017-02844-4.
Results Reference
result

Learn more about this trial

Efficacy of Vibrating Capsule in Patients With Chronic Constipation

We'll reach out to this number within 24 hrs