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This randomized, parallel, double-blind, placebo-controlled trial aims to determine the effects of daily administration of citrus extract over a period of 8 weeks on gastrointestinal health in patients with irritable bowel syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Citrus extract | Experimental | Citrus extract |
|
| Placebo | Placebo Comparator | Maltodextrin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Citrus extract | Dietary Supplement | Citrus extract |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The effect on intestinal inflammation, measured by fecal calprotectin levels. | The primary objective is to assess the effect of 500 mg citrus extract on intestinal flammation after 8 weeks of administration, by measuring fecal calprotectin in IBS patients with moderately increased fecal calprotectin levels. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The effect on microbial metabolic activity, measured by fecal short chain fatty acids (SCFA). | 8 weeks | |
| The effect on fecal microbiota composition, assessed by next generation sequencing. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ad Masclee, MD, PhD | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Maastricht | Limburg | 6229 HX | Netherlands |
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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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| ID | Term |
|---|---|
| C000716707 | grapefruit seed extract |
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| Dietary Supplement |
Maltodextrin |
|
| The effect on fecal microbiota functional capacity, assessed by next generation sequencing. | 8 weeks |
| The effect on the systemic immune response, measured by cytokine production capacity of stimulated whole blood | 8 weeks |
| The effect on disease symptoms, measured by patient reported outcomes (GSRS). | 8 weeks |
| The effect on disease symptoms, measured by patient reported outcomes (symptom diary). | 8 weeks |
| The effect on stool frequency, measured by Bristol Stool Chart. | 8 weeks |
| The effect on stool consistency, measured by Bristol Stool Chart. | 8 weeks |
| The effect on blood markers for oxidative stress, measured by MDA concentration in blood. | 8 weeks |
| The effect on blood markers for antioxidant capacity, measured by blood total antioxidant capacity. | 8 weeks |
| D004066 | Digestive System Diseases |