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

NCT ID: NCT05277428

Last Updated: 2022-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2022-01-29

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.

Detailed Description

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Conditions

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Irritable Bowel Syndrome With Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lactobacillus Plantarum APsulloc 331261(GTB1)

Take GTB1 capsule once daily for 4 weeks

Group Type EXPERIMENTAL

GTB1

Intervention Type DIETARY_SUPPLEMENT

2 capsule/day

Placebo

Take placebo capsule once daily for 4 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

2 capsule/day

Interventions

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GTB1

2 capsule/day

Intervention Type DIETARY_SUPPLEMENT

Placebo

2 capsule/day

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Amorepacific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonghwa Roh, PhD

Role: STUDY_DIRECTOR

Amorepacific R&I center

Locations

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Amorepacific

Yongin-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AP-AR-2020-1

Identifier Type: -

Identifier Source: org_study_id

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