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

A Randomized, Double-blind, Placebo-controlled, Parallel-design Clinical Study to Evaluate the Irritable Bowel Syndrome Symptoms Improving Effect and Safety of Lactobacillus Plantarum APsulloc 331261(GTB1)

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

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome With Diarrhea
• Intervention / Treatment: Dietary supplement: GTB1; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Yongin-si, Gyeonggi-do, Korea, Republic of, 17074
      • Amorepacific

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lactobacillus Plantarum APsulloc 331261(GTB1); Take GTB1 capsule once daily for 4 weeks	Dietary supplement: GTB1; 2 capsule/day
Placebo Comparator: Placebo; Take placebo capsule once daily for 4 weeks.	Dietary supplement: Placebo; 2 capsule/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in a global relief at 4 weeks	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.	Global Relief after 4 weeks of ingestion
Changes in frequency and type of stools at 4 weeks from baseline	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.	Baseline, and 4 weeks of ingestion
Changes in severity and frequency of IBS-Intestinal discomfort symptoms at 4 weeks	Intestinal discomfort symptoms are 3 symptoms that asks: abdominal pain, abdominal bloating, feeling of incomplete evacuation over the past 7 days.	Baseline, and 4 weeks of ingestion

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in a global relief	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.	Global Relief after 1, 2 and 4 weeks of ingestion
Changes in frequency and type of stools	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.	Baseline, 1, 2 and 4 weeks of ingestion and follow-up 2 weeks
Changes in severity and frequency of IBS-Intestinal discomfort symptoms	Intestinal discomfort symptoms are 3 symptoms that asks: abdominal pain, abdominal bloating, feeling of incomplete evacuation over the past 7 days.	Baseline, 1, 2 and 4 weeks of ingestion and follow-up 2 weeks

Collaborators and Investigators

• Sponsor: Amorepacific Corporation
• Investigators: Study Director: Jonghwa Roh, PhD, Amorepacific R&I center

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): January 29, 2022

Study Registration Dates

• First Submitted: February 21, 2022
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 11, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Diarrhea
• Other Study ID Numbers: AP-AR-2020-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No