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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Amorepacific Corporation
- Enrollment
- 27
- Locations
- 2
- Primary Endpoint
- Changes in frequency and type of stools at 4 weeks from baseline
Study Overview
Brief Summary
This study was conducted to investigate the effects of daily supplementation of L. plantarum APsulloc 331261(GTB1TM) on improvement of IBS symptoms.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
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.
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.
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
- 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)
- Changes in Quality of Life at 4 weeks from baseline(Baseline, 1, 2 and 4 weeks of ingestion)
- Fecal microbiome(Baseline, 4 weeks of ingestion)