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The aim of the study is to demonstrate a beneficial effect in reducing symptoms that negatively affect the quality of life of IBS patients, and to demonstrate a positive effect on inflammatory and intestinal function markers.
The double-blind, randomized, placebo-controlled study will be conducted on 48 patients (18-55 years old) with Irritable Bowel Syndrome (IBS). The study will consist of 2 months of supplementation with three parallel arms: 1) probiotic strains and prebiotic (Partially Hydrolyzed Guar Gum); 2) probiotic strains, prebiotic (Partially Hydrolyzed Guar Gum) and elderberry and chokeberry fruit extract; 3) placebo.The study will assess symptoms associated with IBS, using the IBS-QOL questionnaire and the Bristol Stool Formation Scale. Markers of inflammation and intestinal barrier permeability , will be determined in blood and stool samples collected from patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic, Prebiotic, Polyphenol-rich Extracts | Experimental | 18 patients with IBS |
|
| Probiotic, Prebiotic | Experimental | 18 patients with IBS |
|
| Placebo | Placebo Comparator | 18 patients with IBS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic, Prebiotic, Polyphenol-rich Extracts | Dietary Supplement | probiotic strains, prebiotic (Partially Hydrolyzed Guar Gum) and elderberry and chokeberry extract Once a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| IBS-QoL (Irritable Bowel Syndrome-Quality of Life) index | IBS-QoL measures the impact of the disease on the quality of life of patients with IBS | Baseline, 2 months |
| Stool consistency | Will be assessed using the Bristol Stool Chart | Baseline, 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Zonulin | Zonulin level in stool samples | Baseline, 2 months |
| Short-chain fatty acids | Short-chain fatty acids level in stool samples |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu | Recruiting | Poznan | Poland |
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| Probiotic, Prebiotic | Dietary Supplement | probiotic strains, prebiotic (Partially Hydrolyzed Guar Gum) Once a day |
|
| Placebo | Other | placebo Once a day |
|
| Baseline, 2 months |
| IL-6 | IL-6 level in serum samples | Baseline, 2 months |
| IL-8 | IL-8 level in serum samples | Baseline, 2 months |
| I-FABP | I-FABP level in serum samples | Baseline, 2 months |
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| D056692 | Prebiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
| D011134 | Polysaccharides |
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