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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
107
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).
Changhai Hospital
Shanghai, Shanghai Municipality, China
The proportion of patients with the increasing of SCBMs during treatment period≥1
Based on diary card, researchers knew the total times of SCBMs during treatment period. The number divided by the treatment days and multiplied by 7 were the mean SCBMs per week in treatment period. Researcher compared the mean SCBMs per week with SCBMs in baseline period. "Spontaneous" suggested that no laxatives and enema were taken within 24 hours before defecation.
Time frame: Up to 6 weeks
Increase of SCBMs from baseline to treatment period
Based on diary card, researchers knew the SCBMs per week during treatment period. Researchers compared them with SCBMs in baseline period.
Time frame: Up to 6 weeks
The proportion of patients with the increasing of SCBMs ≥1 in at least 4 weeks
Based on diary card, researchers knew the SCBMs of each week. We compared them with SCBMs in baseline period.
Time frame: Up to 6 weeks
Increase of SBMs from baseline to treatment period
SBM means spontaneous bowel movement.
Time frame: Up to 6 weeks
Increase of PAC-QOL score from baseline to treatment period
The PAC-QOLquestionnaire contains 28 items grouped into 4 subscales (Values, 2005) covering: Worries and concerns (11 items), Physical discomfort (4 items), Psychosocial discomfort (8 items), and Satisfaction of treatment (5 items). A 5-point Likert response scale, ranging from 0 (Not at all / none of the time) to 4 (Extremely / All of the time), is used over a 2-week run in period and 6-week treatment period.
Time frame: Up to 6 weeks
The proportion of patients with the increasing of PAC-QOL score during treatment period≥1
At each visit, patients were asked to fill the PAC -QOL questionnaire. The score of PAC-QOL questionnaire in 6-week treatment period were the mean score of three times.
Time frame: Up to 6 weeks
The proportion of patients with the increasing of PAC-SYM score during treatment period≥1
The Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire contained 12 items ( Frank, 1999) assigned to 3 subscales: stool symptoms, rectal symptoms, and abdominal symptoms. Items are scored on 5-point Likert scales, with scores ranging from 0 to 4 (0 = 'symptom absent', 1 = 'mild', 2 = 'moderate', 3 = 'severe' and 4 = 'very severe'). The lower the total score, the lower the symptom burden.
Time frame: Up to 6 weeks
Bristol Score during treatment period
Stool consistency score using Bristol Stool Form Scale (median, range)-1 for hard lumps to 7 for watery stools.
Time frame: Up to 6 weeks
Incidence of adverse events
The safety were assessed by the adverse events occured during this study.
Time frame: Up to 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.