An interventional study of Treat with Vibrabot capsules for at least 7 weeks in Chronic Functional Constipation, sponsored by Beijing Tsinghua Chang Gung Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-08-19.
Sponsored by Beijing Tsinghua Chang Gung Hospital · Not applicable, Interventional, and Treatment
This is a single-center trial. It enrolled nine 18- to 85-year-old patients with chronic constipation to evaluate the efficacy of long-course treatment by using vibrating capsule (VC).
This study was a single-center prospective, single-arm exploratory clinical trial. If a subject signs an Ethics Committee (EC)-approved study informed consent (ICF) that meets the inclusion criteria and does not meet any of the exclusion criteria, the subject is considered eligible for admission to the study.
After completing a baseline questionnaire on bowel movements over the most recent 2 weeks, participants took VC at least 7 weeks, doses ranging from 2 to 5 capsules orally per week. After completion of treatment, subjects entered a follow-up period for at least 8 weeks. During the study period, the subjects are required to keep an e-diary recording daily bowel movements (BMs), medication intake, and discomforts, and complete the Patient Assessment of Constipation Symptoms (PAC-SYM) and the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaires every two weeks.
Subjects are not expected to change their diet or lifestyle during the study. If the subject has not had a bowel movement for three or more consecutive days, the subject is allowed to use another method of defecation to assist with defecation. Subjects are required to avoid antibiotics, probiotics, prebiotics, and proton pump inhibitors throughout their participation in the study.
1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.
This study's enrollment of 9 is below the median of 80 across 850 interventional studies indexed under Constipation.
Browse Constipation studies →Beijing Tsinghua Chang Gung Hospital is the lead sponsor of 96 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects in the trial group took Vibrabot capsules at least 7 weeks, doses ranging from 2 to 5 capsules orally per week.
Drug: Treat with Vibrabot capsules for at least 7 weeks
Subjects in the trial group took Vibrabot capsules at least 7 weeks, doses ranging from 2 to 5 capsules orally per week.
The proportions of responders 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.
Time frame: at least 7 weeks
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 during the treatment period.
Time frame: at least 7 weeks
Number of mean weekly complete spontaneous bowel movements (CSBM).
The average number of complete spontaneous bowel movements per week for each patient during the treatment period.
Time frame: at least 7 weeks
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Beijing Tsinghua Chang Gung Hospital