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

Amorepacific

Status: Completed

Conditions: Irritable Bowel Syndrome With Diarrhea

Treatments: Dietary Supplement: Placebo; Dietary Supplement: GTB1

Study type: Interventional

Funder types: Industry

Identifiers

NCT05277428

AP-AR-2020-1

Details and patient eligibility

About

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

Enrollment: 27 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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27 participants in 2 patient groups, including a placebo group

Lactobacillus Plantarum APsulloc 331261(GTB1)

Experimental group

Description:

Take GTB1 capsule once daily for 4 weeks

Treatment:

Dietary Supplement: GTB1

Placebo

Placebo Comparator group

Description:

Take placebo capsule once daily for 4 weeks.

Treatment:

Dietary Supplement: Placebo