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

• Sponsor: Amorepacific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05277428
• Collaborator: (none)
• Enrollment: 27
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.9
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Irritable Bowel Syndrome With Diarrhea	Dietary Supplement: GTB1; Dietary Supplement: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• 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)
• Actual Study Start Date: Nov 1, 2020
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Jan 29, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lactobacillus Plantarum APsulloc 331261(GTB1) Take GTB1 capsule once daily for 4 weeks	Dietary Supplement: GTB1; 2 capsule/day
Placebo Comparator: Placebo Take placebo capsule once daily for 4 weeks.	Dietary Supplement: Placebo; 2 capsule/day

Outcome Measures

Primary Outcome Measures

1. Changes in a global relief at 4 weeks [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 [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 [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 Outcome Measures

1. Changes in Quality of Life at 4 weeks from baseline [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 [Improvement/worsening assessed after 4 weeks of ingestion]

   Improvement or worsening scale 1-7

3. Fecal microbiome [Baseline, 4 weeks of ingestion]

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

Other Outcome Measures

1. Changes in a global relief [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Amorepacific	Yongin-si	Gyeonggi-do	Korea, Republic of	17074

Sponsors and Collaborators

• Amorepacific Corporation

Investigators

• Study Director: Jonghwa Roh, PhD, Amorepacific R&I center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amorepacific Corporation
• ClinicalTrials.gov Identifier: NCT05277428
• Other Study ID Numbers: AP-AR-2020-1
• First Posted: Mar 14, 2022
• Last Update Posted: May 17, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea

Study Results

No Results Posted as of May 17, 2022