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This study was conducted to investigate the effects of daily supplementation of L. plantarum APsulloc 331261(GTB1TM) on improvement of IBS symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactobacillus Plantarum APsulloc 331261(GTB1) | Experimental | Take GTB1 capsule once daily for 4 weeks |
|
| Placebo | Placebo Comparator | Take placebo capsule once daily for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GTB1 | Dietary Supplement | 2 capsule/day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Improvement or worsening of IBS global symptoms using Participants global impression of change scale and global improvement scale |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Changes in frequency and type of stools |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonghwa Roh, PhD | Amorepacific R&I center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amorepacific | Yongin-si | Gyeonggi-do | 17074 | South Korea |
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| Placebo |
| Dietary Supplement |
2 capsule/day |
|
Improvement or worsening scale 1-7 |
| Improvement/worsening assessed after 4 weeks of ingestion |
| Fecal microbiome | Changes in the fecal microbiome in participants with IBS-D due to use of GTB1 | Baseline, 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. |
| Baseline, 1, 2 and 4 weeks of ingestion and follow-up 2 weeks |
| 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 |