Efficacy and Safety of Vibrating Capsule in Patients With Functional Constipation

Summary

The safety and efficacy of vibrating capsule (VC) in promoting defecation by mechanical stimulation of the gastrointestinal walls have been elucidated in animal studies and pilot clinical studies. Our study aimed to explore the clinical application of a newly developed smartphone-controlled multi-mode VC in the treatment of functional constipation (FC) on multicentres.

Patients referred to gastroenterology outpatient of Changhai Hospital with FC and met the eligible criteria for more than 6 months and with spontaneous complete bowel movement (SCBM) less than 3 times per week within recent 3 weeks were eligible for this study. The study was discussed with patients who satisfied the enrolment criteria and provided written informed consents.

Conditions

• Functional Constipation
• Gastrointestinal Disease
• Capsule Endoscopy

Interventions

DEVICE

Sallowing VC during six weeks

follow-up was required for at least 6 times, once every two weeks through the whole study. For patients who had no colonoscopy examination within a year, colonoscopy was a must to exclude organic diseases. These included blood routine, blood biochemistry, urine routine, fecal routine, fecal occult blood, thyroid stimulating hormone (TSH), blood pregnancy test and ECG examination. Patients should finish all the examination in the run-in period and at the end of treatment period. Dairy cards were designed mainly for the record of the daily defecation of patients and filled out by the enrolled patients, and the content included date, whether the patients swallow capsules (time), whether the patients discharge capsules (time), defecation, defecation time, degree of defecation exertion(0\~4), BSF scale, complete or incomplete defecation, whether the patient had the sense of anal obstruction, whether manual assistance was applied, and whether first-aid medicine was used (bisacodyl).

Sponsors & Collaborators

• Changhai Hospital, Naval Medical University, Shanghai, China.

  collaborator UNKNOWN

• Beijing Xiehe Hospital, Beijing 100000, China.

  collaborator UNKNOWN

• Beijing Jishuitan Hospital, Beijing 100009, China.

  collaborator UNKNOWN

• Tianjin Medical University General Hospital

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• Zhejiang Province Hospital of TCM, The First Affiliated Hospital of Zhejiang TCM University, Hangzhou, China.

  collaborator UNKNOWN

• Changhai Hospital

  lead OTHER

Principal Investigators

• Liao Zhuan, MD · Department of Gastroenterology, Changhai Hospital, the Naval Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-14

Primary Completion

2020-05-11

Completion

2020-10-30

Countries

• China

Study Locations