Status:
COMPLETED
Clinical Study to Evaluate the IBS Symptoms Improving Effect and Safety of GTB1
Lead Sponsor:
Amorepacific Corporation
Conditions:
Irritable Bowel Syndrome With Diarrhea
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
This study was conducted to investigate the effects of daily supplementation of L. plantarum APsulloc 331261(GTB1TM) on improvement of IBS symptoms.
Eligibility Criteria
Inclusion
- Male and female subjects older than 19 years old
- Diagnosed case of IBS using Rome IV criteria
- Who had type 6 or 7 stools according to the BSFS on at least 2 weeks ≥ 25%
- Who voluntarily agreed to participate in the study and signed an informed consent form
Exclusion
- Who had been ingesting products containing probiotics or prebiotics in the 4 weeks preceding entry into the trial
- Who had antibiotic agents during the 4 weeks prior to study entry
- Women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives
- Who is determined ineligible for study participation by investigators for any other reasons
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2022
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT05277428
Start Date
November 1 2020
End Date
January 29 2022
Last Update
May 17 2022
Active Locations (1)
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1
Amorepacific
Yongin-si, Gyeonggi-do, South Korea, 17074