Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06553664
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-11
Brief Title:
The Efficacy of Long-Course Treatment Using Vibrating Capsules for Chronic Constipation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Efficacy of Long-Course Treatment Using Disposable Gastrointestinal Vibrating Capsule Vibrabot Capsule for Chronic Constipation
Status:
COMPLETED
Status Verified Date:
2024-08
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 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
Detailed Description:
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
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
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