Clinical Study to Evaluate the IBS Symptoms Improving Effect and Safety of GTB1

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome With Diarrhea
• Interventions: Dietary Supplement: GTB1; Dietary Supplement: Placebo

• Registration Number: NCT05277428
• Lead Sponsor: Amorepacific Corporation

Brief Summary

This study was conducted to investigate the effects of daily supplementation of L. plantarum APsulloc 331261(GTB1TM) on improvement of IBS symptoms.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-01
• Primary Completion: 2020-12-31
• Study Completion: 2022-01-29
• Study First Submitted: 2022-02-21
• Study First Submitted QC: 2022-03-03
• Study First Posted: 2022-03-14
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-11
• Last Update Posted: 2022-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactobacillus Plantarum APsulloc 331261(GTB1)	GTB1	Take GTB1 capsule once daily for 4 weeks
Placebo	Placebo	Take placebo capsule once daily for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Changes in frequency and type of stools at 4 weeks from baseline	Baseline, and 4 weeks of ingestion	Number of stools per day and type of stools assessed during 7 days before the visit. Type of stools assessed using the Bristol Stool Formation Scale.
Changes in a global relief at 4 weeks	Global Relief after 4 weeks of ingestion	Global relief of IBS is a dichotomous single item that asks participants "Over the past week (7 days) have you had adequate relief of your IBS symptoms?". The answer is YES or NO.
Changes in severity and frequency of IBS-Intestinal discomfort symptoms at 4 weeks	Baseline, and 4 weeks of ingestion	Intestinal discomfort symptoms are 3 symptoms that asks: abdominal pain, abdominal bloating, feeling of incomplete evacuation over the past 7 days.

Secondary Outcome Measures

Name	Time	Method
Improvement or worsening of IBS global symptoms using Participants global impression of change scale and global improvement scale	Improvement/worsening assessed after 4 weeks of ingestion	Improvement or worsening scale 1-7
Changes in Quality of Life at 4 weeks from baseline	Baseline, 1, 2 and 4 weeks of ingestion	Change of dissatisfaction with bowel habit and interfering with general life by Irritable Bowel Syndrome
Fecal microbiome	Baseline, 4 weeks of ingestion	Changes in the fecal microbiome in participants with IBS-D due to use of GTB1

Trial Locations

Locations (1)

Amorepacific; 🇰🇷 Yongin-si, Gyeonggi-do, Korea, Republic of