Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-02 @ 7:06 AM
Study NCT ID:
NCT06526767
Status:
RECRUITING
Last Update Posted:
2024-07-30
First Post:
2024-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of Different Dosages of Vibrabot Capsule in the Treatment of Chronic Functional Constipation
Sponsor:
Beijing Tsinghua Chang Gung Hospital
Organization:
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:
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 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 pill/time (on Monday and Thursday), for six weeks; Trial group 1: Vibrabot capsule administration and dosage were three times a week, one pill/time (Monday, Wednesday, and Friday) for six consecutive weeks; Trial group 2: Vibrabot capsule administration and dosage five times a week, one pill/time (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 pill/time (Monday, Tuesday, Wednesday, Friday, and Saturday); for the middle two weeks, three times a week, one pill/time (Monday, Wednesday, and Friday); and for the last two weeks, two times a week, one pill/time (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, i.e., 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 patient's 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 screening/baseline 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 pill/time (on Monday and Thursday), for six weeks; Trial group 1: Vibrabot capsule administration and dosage were three times a week, one pill/time (Monday, Wednesday, and Friday) for six consecutive weeks; Trial group 2: Vibrabot capsule administration and dosage five times a week, one pill/time (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 pill/time (Monday, Tuesday, Wednesday, Friday, and Saturday); for the middle two weeks, three times a week, one pill/time (Monday, Wednesday, and Friday); and for the last two weeks, two times a week, one pill/time (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, i.e., 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 patient's 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 screening/baseline 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:
True
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?: