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

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

Official Title
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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)

Conditions
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Irritable Bowel Syndrome With Diarrhea

Intervention / Treatment
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* Dietary Supplement: GTB1
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactobacillus Plantarum APsulloc 331261(GTB1)<br>Take GTB1 capsule once daily for 4 weeks | Dietary Supplement: GTB1<br>* 2 capsule/day<br>|
| Placebo Comparator: Placebo<br>Take placebo capsule once daily for 4 weeks. | Dietary Supplement: Placebo<br>* 2 capsule/day<br>|

What is the study measuring?
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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 |