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

Irritable Bowel Syndrome With Diarrhea Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05277428
• Other study ID #: AP-AR-2020-1
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: January 29, 2022

Study information

• Verified date: May 2022
• Source: Amorepacific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 29, 2022
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diarrhea
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome With Diarrhea
• Syndrome

Intervention

Dietary Supplement:
• GTB1
2 capsule/day
• Placebo
2 capsule/day

Locations

Country	Name	City	State
Korea, Republic of	Amorepacific	Yongin-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Amorepacific Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in a global relief	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 1, 2 and 4 weeks of ingestion
Other	Changes in frequency and type of stools	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, 1, 2 and 4 weeks of ingestion and follow-up 2 weeks
Other	Changes in severity and frequency of IBS-Intestinal discomfort symptoms	Intestinal discomfort symptoms are 3 symptoms that asks: abdominal pain, abdominal bloating, feeling of incomplete evacuation over the past 7 days.	Baseline, 1, 2 and 4 weeks of ingestion and follow-up 2 weeks
Primary	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
Primary	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
Primary	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	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	Baseline, 1, 2 and 4 weeks of ingestion
Secondary	Improvement or worsening of IBS global symptoms using Participants global impression of change scale and global improvement scale	Improvement or worsening scale 1-7	Improvement/worsening assessed after 4 weeks of ingestion
Secondary	Fecal microbiome	Changes in the fecal microbiome in participants with IBS-D due to use of GTB1	Baseline, 4 weeks of ingestion