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

NCT05277428 | Completed

• 1 other identifier: AP-AR-2020-1
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Irritable Bowel Syndrome With Diarrhea

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Changes in Quality of Life at 4 weeks from baseline

  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/worsening assessed after 4 weeks of ingestion

• Fecal microbiome

  Baseline, 4 weeks of ingestion

Other Outcomes (3)

• Changes in a global relief

  Global Relief after 1, 2 and 4 weeks of ingestion

• Changes in frequency and type of stools

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

• Changes in severity and frequency of IBS-Intestinal discomfort symptoms

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

Study Arms (2)

Lactobacillus Plantarum APsulloc 331261(GTB1)

EXPERIMENTAL

Take GTB1 capsule once daily for 4 weeks

Dietary Supplement: GTB1

Placebo

PLACEBO COMPARATOR

Take placebo capsule once daily for 4 weeks.

Dietary Supplement: Placebo

Interventions

GTB1 DIETARY_SUPPLEMENT

2 capsule/day

Lactobacillus Plantarum APsulloc 331261(GTB1)

Placebo DIETARY_SUPPLEMENT

2 capsule/day

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amorepacific Corporation: lead

Study Sites (1)

Amorepacific

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

Location

Study Officials

• Jonghwa Roh, PhD

  Amorepacific R&I center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: March 14, 2022
• Study Start: November 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: January 29, 2022
• Last Updated: May 17, 2022

Record last verified: 2022-05

Locations

KR (1)