Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06526767
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-14
Brief Title:
Comparative Study of Different Dosages of Vibrabot Capsule in the Treatment of Chronic Functional Constipation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparative Study of Different Dosages of Disposable Gastrointestinal Vibrating Capsule Vibrabot Capsule in the Treatment of Mild to Moderate Chronic Functional Constipation
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 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
Detailed Description:
This study was a single-center prospective randomized parallel-controlled 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 Participants with chronic functional constipation enrolled in the study completed a two-week baseline period in which they were advised to avoid taking any laxatives or other treatments for their constipation as much as possible After the two-week basal period all subjects were randomly assigned to the control group trial group 1 trial group 2 and trial group 3 for the corresponding treatment
Control group Vibrabot capsule was taken twice a week one pilltime on Monday and Thursday for six weeks Trial group 1 Vibrabot capsule administration and dosage were three times a week one pilltime Monday Wednesday and Friday for six consecutive weeks Trial group 2 Vibrabot capsule administration and dosage five times a week one pilltime Monday Tuesday Wednesday Friday and Saturday for six weeks Trial group 3 Vibrabot capsule administration and dosage for the first two weeks five times a week one pilltime Monday Tuesday Wednesday Friday and Saturday for the middle two weeks three times a week one pilltime Monday Wednesday and Friday and for the last two weeks two times a week one pilltime Monday and Thursday
The subjects who receive Vibrabot capsules will undergo 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
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
Control group Vibrabot capsule was taken twice a week one pilltime on Monday and Thursday for six weeks Trial group 1 Vibrabot capsule administration and dosage were three times a week one pilltime Monday Wednesday and Friday for six consecutive weeks Trial group 2 Vibrabot capsule administration and dosage five times a week one pilltime Monday Tuesday Wednesday Friday and Saturday for six weeks Trial group 3 Vibrabot capsule administration and dosage for the first two weeks five times a week one pilltime Monday Tuesday Wednesday Friday and Saturday for the middle two weeks three times a week one pilltime Monday Wednesday and Friday and for the last two weeks two times a week one pilltime Monday and Thursday
The subjects who receive Vibrabot capsules will undergo 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None