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

Primary Purpose

Irritable Bowel Syndrome With Diarrhea

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

GTB1

Placebo

About this trial

This is an interventional other trial for Irritable Bowel Syndrome With Diarrhea

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Amorepacific

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lactobacillus Plantarum APsulloc 331261(GTB1)

Placebo

Arm Description

Take GTB1 capsule once daily for 4 weeks

Take placebo capsule once daily for 4 weeks.

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

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

Improvement or worsening of IBS global symptoms using Participants global impression of change scale and global improvement scale

Improvement or worsening scale 1-7

Fecal microbiome

Changes in the fecal microbiome in participants with IBS-D due to use of GTB1

Full Information

NCT ID

NCT05277428

First Posted

February 21, 2022

Last Updated

May 11, 2022

Sponsor

Amorepacific Corporation

1. Study Identification

Unique Protocol Identification Number

NCT05277428

Brief Title

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

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

November 1, 2020 (Actual)

Primary Completion Date

December 31, 2020 (Actual)

Study Completion Date

January 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amorepacific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome With Diarrhea

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lactobacillus Plantarum APsulloc 331261(GTB1)

Arm Type

Experimental

Arm Description

Take GTB1 capsule once daily for 4 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Take placebo capsule once daily for 4 weeks.

Intervention Type

Dietary Supplement

Intervention Name(s)

GTB1

Intervention Description

2 capsule/day

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

2 capsule/day

Primary Outcome Measure Information:

Title

Changes in a global relief at 4 weeks

Description

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

Title

Changes in frequency and type of stools at 4 weeks from baseline

Description

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

Title

Changes in severity and frequency of IBS-Intestinal discomfort symptoms at 4 weeks

Description

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 Outcome Measure Information:

Title

Changes in Quality of Life at 4 weeks from baseline

Description

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

Title

Improvement or worsening of IBS global symptoms using Participants global impression of change scale and global improvement scale

Description

Improvement or worsening scale 1-7

Time Frame

Improvement/worsening assessed after 4 weeks of ingestion

Title

Fecal microbiome

Description

Changes in the fecal microbiome in participants with IBS-D due to use of GTB1

Time Frame

Baseline, 4 weeks of ingestion

Other Pre-specified Outcome Measures:

Title

Changes in a global relief

Description

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 1, 2 and 4 weeks of ingestion

Title

Changes in frequency and type of stools

Description

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, 1, 2 and 4 weeks of ingestion and follow-up 2 weeks

Title

Changes in severity and frequency of IBS-Intestinal discomfort symptoms

Description

Intestinal discomfort symptoms are 3 symptoms that asks: abdominal pain, abdominal bloating, feeling of incomplete evacuation over the past 7 days.

Time Frame

Baseline, 1, 2 and 4 weeks of ingestion and follow-up 2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jonghwa Roh, PhD

Organizational Affiliation

Amorepacific R&I center

Official's Role

Study Director

Facility Information:

Facility Name

Amorepacific

City

Yongin-si

State/Province

Gyeonggi-do

ZIP/Postal Code

17074

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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