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

Amorepacific Corporation27 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Irritable Bowel Syndrome With Diarrhea

Interventions

GTB1DIETARY_SUPPLEMENT

2 capsule/day

PlaceboDIETARY_SUPPLEMENT

2 capsule/day

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Amorepacific

Yongin-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline, and 4 weeks of ingestion

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: Baseline, 4 weeks of ingestion

Data from ClinicalTrials.gov

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