This is a single-center trial that enrolls 120 18- to 85-year-old patients with mild to moderate chronic functional constipation to study the dose-response relationship of the Vibrabot capsule as well as the mechanism of action of the Vibrabot capsule.
Straining during more than one-fourth (25%) of defecations;
Lumpy or hard stools (BSFS 1-2) more than one-fourth (25%) of defecations;
Sensation of incomplete evacuation more than one-fourth (25%) of defecations;
Sensation of anorectal obstruction/blockage more than one-fourth (25%) of defecations;
People who are not eligible for surgery or refuse to undergo any abdominal surgery.
People with known or suspected gastrointestinal obstruction, stenosis, diverticulum, bleeding, malformation, and fistula.
People allergic to polymeric materials.
People implanted with cardiac pacemakers and using gastrointestinal pacemakers.
Parallel
Vibrabot capsules twice a week
DeviceSubjects in control group took Vibrabot capsules twice a week, one pill/time (on Monday and Thursday), for six weeks.
Vibrabot capsules three times a week
DeviceSubjects in trial group 1 took Vibrabot capsules three times a week, one pill/time (Monday, Wednesday, and Friday) for six consecutive weeks.
Vibrabot capsules five times a week
DeviceSubjects in trial group 2 took Vibrabot capsules five times a week, one pill/time (Monday, Tuesday, Wednesday, Friday, and Saturday), for six weeks.
Vibrabot capsules loading dose
DeviceSubjects in trial group 3 took Vibrabot capsules one pill/time, five times a week (Monday, Tuesday, Wednesday, Friday, and Saturday) during the first two weeks, three times a week (Monday, Wednesday, and Friday) during the middle two weeks, and two times a week (Monday and Thursday) during the last two weeks.
The proportions of responders to the four therapies during the treatment period.
Responders are the subjects with an average increase of ≥1 complete spontaneous bowel movements (CSBMs) per week during the treatment period compared to the baseline period.
The changes in neurotransmitter levels before and after treatment with Vibrabot capsules.
Patients should have blood samples collected before and after treatment for the measurement of neurotransmitters such as Substance P (SP), Serotonin (5-HT), Nitric Oxide (NO), and Gamma-Aminobutyric Acid (GABA).
The changes in fecal microbiota before and after treatment with Vibrabot capsules.
Patients should collect fecal specimens before and after treatment for the analysis of fecal microbiota species and abundance through 16S rRNA sequencing.
Assessment of quality of life among different treatment groups.
The PAC-QOL questionnaire is the most validated tool for measuring the quality of life of patients with constipation. It consists of 28 self-reported items investigating the effects of constipation on the patient's quality of life in the past 2 weeks. The PAC-QOL questionnaire is subcategorized into 4 items on physical discomfort, 8 items on psychosocial discomfort, 5 items on treatment satisfaction, and finally 11 items on worries and discomfort. The response choice is on a Likert scale from 0 to 4. Higher scores mean higher negative effects on quality of life.
Assessment of the severity of patient-reported symptoms among different treatment groups.
The PAC-SYM questionnaire has emerged as an important tool for assessing the severity of patient-reported symptoms of constipation. The 12-item questionnaire is divided into three symptom subscales: abdominal (four items); rectal (three items); and stool (five items). 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'). A mean total score in the range of 0-4 is generated by dividing the total score by the number of questions completed; the lower the total score, the lower the symptom.
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