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

Sponsor

Örebro University, Sweden (Other)

Overall Status

Completed

CT.gov ID

NCT05446610

Collaborator

Harokopio University (Other), Agricultural University of Athens (Other), National Hellenic Research Foundation (Other)

Enrollment

Location

Arm

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Fermented product of Pleurotus eryngii mushroom	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Mar 17, 2020

Actual Primary Completion Date :

Sep 18, 2020

Actual Study Completion Date :

Jun 17, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gut barrier function treatments Stressor, fibre, combination of treatments.	Other: Fermented product of Pleurotus eryngii mushroom I Stimulation of human colonic biopsies with the fermented product of Pleurotus eryngii mushroom

Arm

Intervention/Treatment

Experimental: Gut barrier function treatments

Stressor, fibre, combination of treatments.

Other: Fermented product of Pleurotus eryngii mushroom

I Stimulation of human colonic biopsies with the fermented product of Pleurotus eryngii mushroom

Outcome Measures

Primary Outcome Measures

Change from baseline of barrier function (paracellular permeability) after 90 minutes of ex vivo stimulation of the colonic biopsies. [Barrier function will be measured at baseline and 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.
Change from baseline of barrier function (transcellular permeability) after 90 minutes of ex vivo stimulation of the colonic biopsies. [Barrier function will be measured at baseline and 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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