The Effects of the Synbiotic Ecologic 825/scFOS on Intestinal Barrier Function and Immune Modulation

Study Overview
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Brief Summary
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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.

Official Title
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The Effects of the Synbiotic Ecologic 825/scFOS on Intestinal Barrier Function

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Dietary Supplement: Ecologic 825/scFOS
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Based on medical history and previous self-admitted examination, no gastrointestinal complaints can be defined Age between 18 and 65 years Body Mass Index (BMI) between 20 and 30 kilogram/m2 Exclusion Criteria: History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, head, ears, eyes, nose, throat (HEENT), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. - Use of medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing Administration of probiotic supplements, investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study Use of antibiotics in the 90 days prior to the study Abdominal surgery interfering with gastrointestinal function, upon judgment of the principle investigator) Pregnancy, lactation Excessive alcohol consumption (>20 alcoholic consumptions per week) Smoking Blood donation within 3 months before or after the study period Self-admitted Human immunodeficiency virus-positive state History of any side effects towards intake of pro- or prebiotic supplements of any kind

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Dietary Supplement: Placebo<br> <br> |
| Experimental: Ecologic 825/scFOS<br>Ecologic 825/scFOS | Dietary Supplement: Ecologic 825/scFOS<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sugar recovery in urine, as indicator of intestinal permeability |  | Baseline and after 2 weeks intervention | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbiota, Synbiotics, Intestinal permeability, Immune response