Investigating Effects in Intestinal Permeability of Rich in Beta-glucans Pleurotus Eryngii Mushrooms Fermentation Supernatants: an Ex-vivo Study

Study Overview
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Brief Summary
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The aim of the present study was to investigate the ability of Pleurotus eryngii mushrooms fermentation products (FS) to counteract induced intestinal hyperpermeability in human colonic tissues in an ex vivo system.

Detailed Description
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Collection of colon biopsies through sigmoidoscopy procedure will take place and the collected biopsies will be mounted in Ussing Chambers. Already collected fermentation supernatants will be added to the mucosal side of the biopsy together with a stressor and two permeability markers, in order to investigate the effects of the fibre fractions on both paracellular and transcellular permeability.

Official Title
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Development of a Novel Functional Food Enriched With Beta-glucans Isolated From Edible Mushrooms of Greek Habitats

Conditions
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Healthy

Intervention / Treatment
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* Other: Fermented product of Pleurotus eryngii mushroom


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed consent prior to any study related procedures Age 18-65 years Willing to abstain from regular consumption of prebiotics/probiotics products or medication known to alter gastrointestinal functions at least 4 weeks prior to the study visits Exclusion Criteria: Previous complicated gastrointestinal surgery Presence of gastrointestinal disorder or any disorder which the principal investigator considers to affect the results of the study Current diagnosis of psychiatric disease Current and past diagnosis inflammatory gastrointestinal disease (e.g. Irritable Bowel Disease) Systemic use of antibiotics or steroids medications in the last 3 months Frequent use of NSAID (Non Steroidal Anti Inflammatory Drugs) the last 2 months prior to study visits Regular consumption of prebiotic/probiotic products for the past 4 weeks Abuse of alcohol or drugs Frequent use of laxatives, anti-diarrheal, anti-cholinergic within last 12 weeks prior to study visits Pregnancy and breast-feeding

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gut barrier function treatments<br>Stressor, fibre, combination of treatments. | Other: Fermented product of Pleurotus eryngii mushroom<br>* I Stimulation of human colonic biopsies with the fermented product of Pleurotus eryngii mushroom<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of barrier function (paracellular permeability) after 90 minutes of ex vivo stimulation of the colonic biopsies. | Barrier function (paracellular permeability) will be evaluated with the use of marker related this permeability, through immunofluoresence. | Barrier function will be measured at baseline and after 90 minutes of ex vivo stimulation of the colonic biopsies. | 
| Change from baseline of barrier function (transcellular permeability) after 90 minutes of ex vivo stimulation of the colonic biopsies. | Barrier function (transcellular permeability) will be evaluated with the use of marker related to this permeability, through ELISA tecnhique. | Barrier function will be measured at baseline and after 90 minutes of ex vivo stimulation of the colonic biopsies. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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paracellular permeability, transcellular permability, Pleurotus eryngii, beta glucan, prebiotic