Skip to main content
OpenTrials
Completed

NCT Number: NCT05277428

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Irritable Bowel Syndrome With Diarrhea

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amorepacific

Yongin-si, Gyeonggi-do, 17074, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GTB1

Dietary Supplement

2 capsule/day

Placebo

Dietary Supplement

2 capsule/day

Primary outcomes

  1. Changes in a global relief at 4 weeks

    Time frame: Global Relief after 4 weeks of ingestion

    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.

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

    Time frame: Baseline, and 4 weeks of ingestion

    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.

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

    Time frame: Baseline, and 4 weeks of ingestion

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

Secondary outcomes

  1. Changes in Quality of Life at 4 weeks from baseline

    Time frame: Baseline, 1, 2 and 4 weeks of ingestion

    Change of dissatisfaction with bowel habit and interfering with general life by Irritable Bowel Syndrome

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

    Time frame: Improvement/worsening assessed after 4 weeks of ingestion

    Improvement or worsening scale 1-7

  3. Fecal microbiome

    Time frame: Baseline, 4 weeks of ingestion

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

Other outcomes

  1. Changes in a global relief

    Time frame: Global Relief after 1, 2 and 4 weeks of ingestion

    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.

  2. Changes in frequency and type of stools

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

    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.

  3. Changes in severity and frequency of IBS-Intestinal discomfort symptoms

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

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

Sponsors and collaborators

Lead sponsor

Amorepacific Corporation

Industry

Registry information

Official study 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)

Important dates

Study start
2020
Primary completion
2020
Study completion
2022
First posted
Mar 14, 2022
Registry last updated
May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.