Efficacy of Vibrating Capsule in Patients With Chronic Constipation

Chronic Constipation Clinical Trial

Official title:

Efficacy of Vibrating Capsule in Patients With Chronic Constipation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03508076
• Other study ID #: Vibrating Capsule
• Status: Recruiting
• Phase: N/A
• First received: April 23, 2017
• Last updated: April 16, 2018
• Start date: February 1, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: April 2018
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation

Intervention

Device:
• Vibrating Capsule
Patients in this group would be treated with Vibrating Capsule
• Sham Capsule
Capsules can't vibrate but look the same as Vibrating Capsule

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	defecation frequency	the average weekly defecation frequency	8 weeks
Secondary	Bristol Stool Chart	Record the BSC of each defecation.	8 weeks
Secondary	first defecation	The time of complete defecation after taking the capsule for the first time	8 weeks