Efficacy of Vibrating Capsule in Patients With Chronic Constipation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Vibrating Capsule in Patients With Chronic Constipation

Conditions
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Chronic Constipation

Intervention / Treatment
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* Device: Vibrating Capsule
* Device: Sham Capsule


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham Capsule<br>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<br>* Capsules can't vibrate but look the same as Vibrating Capsule<br>|
| Experimental: Vibration Capsule of low level<br>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<br>* Patients in this group would be treated with Vibrating Capsule<br>|
| Experimental: Vibration Capsule of high level<br>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<br>* Patients in this group would be treated with Vibrating Capsule<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vibrating Capsule, Efficacy and Safety, Chronic Constipation, different vibrating modes