Comparative Study of Different Dosages of Vibrabot Capsule in the Treatment of Chronic Functional Constipation
NCT Number: NCT06526767
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Functional Constipation
Interventions: DEVICE: Vibrabot capsules twice a week|DEVICE: Vibrabot capsules three times a week|DEVICE: Vibrabot capsules five times a week|DEVICE: Vibrabot capsules loading dose
Sponsor: Beijing Tsinghua Chang Gung Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-23
Completion Date: 2025-12-31
Locations: XuanJiang, Beijing, Beijing, 102218, China

Summary:
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.

Primary Outcome Measures: 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., 6 weeks
Secondary Outcome Measures: 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)., 6 weeks of treatment.|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., 6 weeks of treatment.|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., Every 2 weeks during the treatment period and the follow-up period, up to 14 weeks.|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., Every 2 weeks during the treatment period and the follow-up period, up to 14 weeks.|The proportions of responders to the four therapies during the follow-up period., Responders are the subjects with an average increase of ≥1 complete spontaneous bowel movements (CSBMs) per week during the follow-up period compared to the baseline period., 8 weeks of follow-up.|The proportion of patients with complete spontaneous defecation (CSBM) ≥three times per week during the treatment period;, Evaluating the proportion of patients with complete spontaneous defecation (CSBM) ≥three times per week among different treatment groups during the treatment period., 6 weeks of treatment.|The proportion of patients with complete spontaneous defecation (CSBM) ≥three times per week during the follow-up period., Evaluating the proportion of patients with complete spontaneous defecation (CSBM) ≥three times per week among different treatment groups during the follow-up period., 8 weeks of follow-up.