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To assess safety, including adverse reactions, vital signs (including weight), physical examination, and changes in blood test results.
To examine the rate of positive gut quotient (gQ) values in patients diagnosed with IBS as per the ROME III criteria. Further, to examine how the ROME III-based symptom scale score compared with that of the quality of life scale in the gQ questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gQ-lab daily | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gQ-lab daily | Dietary Supplement | probiotics |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom questionnaire survey (VAS score) | To assess satisfaction with overall improvement in bowel symptoms, after 4 weeks of administration of GQ lab to patients with irritable bowel syndrome (IBS). The range of the VAS score is 1 to 10. The lower the value of the VAS score, the better. The value of the endpoint (4 weeks) is compared in the placebo group versus the treatment group. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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randomized, double-blind, placebo-controlled, parallel-group
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| Dietary Supplement |
powdered skim milk, lactose |
|
| D004066 | Digestive System Diseases |