Efficacy and Safety of Vibrating Capsule in Patients With Functional Constipation
Condition: Functional Constipation; Gastrointestinal Disease; Capsule Endoscopy
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases; Constipation
Study type: Interventional

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.
    

Detailed description: 
      This study was a multicentred, double-blind, placebo-controlled clinical trial to assess the
      safety and the effecacy of a newly developed gastrointestinal vibrating capsule (VC) in
      treating patients with functional constipation (FC). The whole process included two weeks
      run-in period, six weeks double-blind, placebo-controlled treatment period, and a follow-up
      period until the discharge of all swallowed capsules. During treatment period, patients were
      required to swallow one capsule every three to four days and a total of twelve capsules.

      For each patient, a face to face follow-up was required for at least 6 times, once every two
      weeks through the whole study.

      Run-in period (Visit 1) Face to face consultation in gastroenterology outpatient clinic and
      sign of written informed consents; Barium enema or colonoscopy (no re-examination is needed
      if the patient has undergone barium enema or total colonoscopy within a year); Distribution
      of bisacodyl tablets and diary cards; Perform the following examinations: vital signs,
      physical examination and laboratory examination; Eligibility evaluation based on the
      entry/discharge criteria; Record of past medical history, concomitant diseases and
      medication; Collection of the baseline characteristics of the enrolled patients including
      age, sex, duration of constipation, mean SCBMs, spontaneous bowel movements (SBMs), BMs,
      frequency of bisacodyl tablets taken and Bristol Score.

      Treatment period Visit 2： Randomization; Patients were asked to fill in PAC-SYM, PAC-QOL and
      Comprehensive Evaluation Questionnaire; Record of vital signs and physical examination;
      Distribution of bisacodyl tablets, capsule retrieving bags and VCs; Instruct patients how to
      use the control board and start the vibration of VCs; Recycle of bisacodine tablets;
      Distribution and collection of diary cards; Record of adverse events, concomitant diseases
      and medication. Visit 3, Visit 4： Patients were asked to fill in PAC-SYM, PAC-QOL and
      Comprehensive Evaluation Questionnaire; Record of vital signs and physical examination;
      Recheck fecal routine and occult blood examination; Distribution of bisacodyl tablets,
      capsule retrieving bags and VCs; Recycle of bisacodyl tablets and VCs; Distribution and
      collection of diary cards; Record of adverse events, concomitant diseases and medication.
      Visit 5： Patients were asked to fill in PAC-SYM, PAC-QOL and Comprehensive Evaluation
      Questionnaire; Record of vital signs and physical examination; ECG; Blood routine/blood
      biochemistry/urine routine; Fecal routine and occult blood; Recycle of bisacodyl tablets and
      VCs; Distribution and collection of diary cards; Distribution of capsule retrieving bags;
      Record of adverse events, concomitant diseases and medication.

      Follow-up period (Visit6):

      Determine the discharge of all capsules; Recycle of capsules; Collection of diary cards;
      During the follow-up period, once the capsule was discharged the follow-up would be ended. If
      the capsules were still in the body, the patients must continue the follow-up until the
      capsules were all discharged.

      The primary endpoint was the proportion of patients with SBM increased more than 1 time
      during treatment period. Secondary endpoints including mean SCBM , SBM , bowel movement (BM)
      and their improvements , Bristol Score, capsule evacuation time and satisfaction level.
      Patients were continuously monitored for adverse events (AE) at baseline and at each visit.
      Satisfaction level were evaluated based on Patient Assessment of Constipation Quality of Life
      questionnaire (PAC-QOL) and Patient Assessment of Constipation Symptom (PAC-SYM) at each
      visit.
    

Intervention name(s): Sallowing VC during six weeks
Intervention type(s): Device
Intervention description(s): 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).
Other intervention name(s): Performing and reporting colonoscopy; Having laboratory examination; Filling diary cards; Evaluating the satisfaction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Vibrating capsule; Functional Constipation; Spontaneous Bowel Movement; Clinical Trial