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In the present pilot study, the investigators will study the effects of a novel synbiotic, which is a mix of probiotics (Ecologic 825) in the presence of a prebiotic (short chain fructo-oligosaccharide (scFOS)), on mucosal integrity, overall microbiota changes along the gastrointestinal-tract and the mucosal immune response. The investigators hypothesize that the synbiotic Ecologic 825/scFOS will significantly affect the intestinal permeability and modulate the immune system in humans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| Ecologic 825/scFOS | Experimental | Ecologic 825/scFOS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ecologic 825/scFOS | Dietary Supplement |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Sugar recovery in urine, as indicator of intestinal permeability | Baseline and after 2 weeks intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers of immune modulation; plasma levels of Tumor necrosis factor alpha , Interleukin-1 beta, Interleukin-6, Interleukin-8, Interleukin-17, Monocyte chemoattractant protein-1 and Macrophage inflammatory protein-1a | Baseline and after 2 weeks intervention | |
| Relative abundance of commensal rat ileum bacterium (CRIB) by quantitative polymerase chain reaction (qPCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| A.A.M. Masclee, Professor | Department of Internal Medicine, Division of Gastroenterology-Hepatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Maastricht | Limburg | 6229 HX | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38738780 | Derived | An R, Wilms E, Gerritsen J, Kim HK, Perez CS, Besseling-van der Vaart I, Jonkers DMAE, Rijkers GT, de Vos WM, Masclee AAM, Zoetendal EG, Troost FJ, Smidt H. Spatio-temporal dynamics of the human small intestinal microbiome and its response to a synbiotic. Gut Microbes. 2024 Jan-Dec;16(1):2350173. doi: 10.1080/19490976.2024.2350173. Epub 2024 May 13. |
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|
| Baseline and after 2 weeks intervention |
| Barcoded pyrosequencing of 16S rRNA genes of the microbiota | Baseline and after 2 weeks intervention |
| Metatranscriptomics of the microbiota | Baseline and after 2 weeks intervention |
| 10 item gastrointestinal symptom diary | Baseline and after 2 weeks intervention |
| Quantitative Insights Into Microbial Ecology (QIIME) of the microbiota | Baseline and after 2 weeks intervention |