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| Name | Class |
|---|---|
| Beneo GmbH | INDUSTRY |
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The purpose of this study is to see how the prebiotic inulin changes the gut bacteria (microbiome) of children and young adults with IBD and determine if this dietary intervention can help reduce disease activity.
The pathogenesis of inflammatory bowel disease (IBD) is thought to be due to a combination of genetic, environmental and immunological factors. From a clinical stand point, there is great interest in determining if manipulation of the gut microbiota may be a viable therapeutic strategy in IBD patients. One such strategy involves the use of prebiotic. Prebiotics are oligosaccharides that cannot be enzymatically hydrolyzed in the small intestine, however serve as substrates for fermentation by commensal bacteria in the colon.
Investigators propose to evaluate the modulatory effects of the prebiotic inulin on the composition and function of the microbiota of children with IBD and determine the efficacy of this dietary intervention in reducing disease activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inulin | Experimental | Oligofructose-enriched Inulin (OI) administered for 8 weeks |
|
| Placebo | Placebo Comparator | Maltodextrin placebo administered for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oligofructose-enriched Inulin OI | Dietary Supplement | Consumed as a powder, 8g/d for children <50kg and 16g/d for children ≥50kg, divided in 2 daily doses. |
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| Measure | Description | Time Frame |
|---|---|---|
| Alteration of gut microbiota and metabolome | The primary outcome will be assessed based on specific inulin-induced changes in microbiome composition and metabolome with a focus on short-chain fatty acid (SCFA) producers and their metabolites at week 8. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fecal calprotectin level | Change in fecal calprotectin following OI supplementation will be assessed 8 weeks after randomization. | 8 weeks |
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Inclusion Criteria
Males or females age 8-21 years.
Parental/guardian permission (informed consent) and child assent.
Pediatric diagnosis of inflammatory colonic or ileocolonic Crohn's disease (CD), ulcerative colitis (UC) or inflammatory bowel disease-unclassified (IBDU), as defined by endoscopy, radiology, and clinical findings.
Clinical disease activity index compatible with:
For patients with CD:
For patients with UC/IBDU:
Fecal calprotectin (FC) ≥ 50 ≤ 500mcg/g or FC outside of this range but within the 20% margin of error of 500 mcg/g
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Breton, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19146 | United States |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
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| Maltodextrin | Dietary Supplement | Consumed as a powder, 8g/d for children <50kg and 16g/d for children ≥50kg, divided in 2 daily doses. |
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