Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06364111
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2023-12-12
Brief Title:
Comparative Study on the Efficacy of Vibrabot Capsule and Polyethylene Glycol for Chronic Functional Constipation
Sponsor:
Beijing Tsinghua Chang Gung Hospital
Organization:
Beijing Tsinghua Chang Gung Hospital
Study Overview
Official Title:
Comparative Study on the Efficacy of Disposable Gastrointestinal Vibrating Capsule Vibrabot Capsule and Polyethylene Glycol for Chronic Functional Constipation
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-center trial that enrolls 20 18 to 85-year-old patients with moderate to severe FC to study the efficacy of Vibrabot capsule dosage 5 capsulesweek and polyethylene glycol as well as the mechanism of action of the Vibrabot capsule
Detailed Description:
This study is a prospective parallel controlled clinical trial Subjects are considered eligible for this study if they meet the inclusion criteria and do not meet any of the exclusion criteria They must sign an Ethics Committee EC-approved Informed Consent Form ICF and be randomly assigned to trial group 1 trial group 2 and control group for the respective treatment
Subjects in Trial Group 1 received polyethylene glycol combined with Vibrabot capsules for 2 weeks and then Vibrabot capsules for 4 weeks Subjects in Trial Group 2 received Vibrabot capsules for 12 consecutive weeks Subjects in the control group received polyethylene glycol for 6 weeks and subjects with poor efficacy could voluntarily choose to continue to receive Vibrabot capsules for 6 weeks During the treatment period the dosage of Vibrabot capsule is 1 capsuletime 5 timesweek and that of polyethylene glycol is 10gtime twiceday The subjects who receive Vibrabot capsules will undergo a colonic transit study a radionuclide imaging-based gastrointestinal transit assessment an anorectal manometry a neurotransmitter test and a fecal flora test before and after the treatment After completion of treatment subjects in each group entered a follow-up period which was observed until the patient regained symptoms of constipation ie when laxatives or other bowel-promoting treatments were used If the subject never recovered from constipation a minimum of 8 weeks of questionnaire completion was required depending on the patients compliance status 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
This study consists of a screeningbaseline period a treatment period and a follow-up period During the study subjects are required not to change their diet and lifestyle The washout or follow-up period will end once the subject uses rescue medication If subjects have no BM for three or more consecutive days they are permitted to take bisacodyl as rescue medication If they cannot tolerate bisacodyl an enema may be used instead They should avoid antibiotics probiotics prebiotics and proton pump inhibitors throughout their participation in the study
Subjects in Trial Group 1 received polyethylene glycol combined with Vibrabot capsules for 2 weeks and then Vibrabot capsules for 4 weeks Subjects in Trial Group 2 received Vibrabot capsules for 12 consecutive weeks Subjects in the control group received polyethylene glycol for 6 weeks and subjects with poor efficacy could voluntarily choose to continue to receive Vibrabot capsules for 6 weeks During the treatment period the dosage of Vibrabot capsule is 1 capsuletime 5 timesweek and that of polyethylene glycol is 10gtime twiceday The subjects who receive Vibrabot capsules will undergo a colonic transit study a radionuclide imaging-based gastrointestinal transit assessment an anorectal manometry a neurotransmitter test and a fecal flora test before and after the treatment After completion of treatment subjects in each group entered a follow-up period which was observed until the patient regained symptoms of constipation ie when laxatives or other bowel-promoting treatments were used If the subject never recovered from constipation a minimum of 8 weeks of questionnaire completion was required depending on the patients compliance status 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
This study consists of a screeningbaseline period a treatment period and a follow-up period During the study subjects are required not to change their diet and lifestyle The washout or follow-up period will end once the subject uses rescue medication If subjects have no BM for three or more consecutive days they are permitted to take bisacodyl as rescue medication If they cannot tolerate bisacodyl an enema may be used instead They should avoid antibiotics probiotics prebiotics and proton pump inhibitors throughout their participation in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None