Irritable Bowel Syndrome With Diarrhea
Conditions
Brief summary
This study was conducted to investigate the effects of daily supplementation of L. plantarum APsulloc 331261(GTB1TM) on improvement of IBS symptoms.
Interventions
DIETARY_SUPPLEMENTGTB1
2 capsule/day
DIETARY_SUPPLEMENTPlacebo
2 capsule/day
Sponsors
Amorepacific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Fecal microbiome | Baseline, 4 weeks of ingestion | Changes in the fecal microbiome in participants with IBS-D due to use of GTB1 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
South Korea
Outcome results
None listed