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

July 3, 2022 updated by: Örebro University, Sweden

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Örebro, Sweden, 703 62
        • Campus USÖ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Signed consent prior to any study related procedures
  2. Age 18-65 years
  3. 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:

  1. Previous complicated gastrointestinal surgery
  2. Presence of gastrointestinal disorder or any disorder which the principal investigator considers to affect the results of the study
  3. Current diagnosis of psychiatric disease
  4. Current and past diagnosis inflammatory gastrointestinal disease (e.g. Irritable Bowel Disease)
  5. Systemic use of antibiotics or steroids medications in the last 3 months
  6. Frequent use of NSAID (Non Steroidal Anti Inflammatory Drugs) the last 2 months prior to study visits
  7. Regular consumption of prebiotic/probiotic products for the past 4 weeks
  8. Abuse of alcohol or drugs
  9. Frequent use of laxatives, anti-diarrheal, anti-cholinergic within last 12 weeks prior to study visits
  10. Pregnancy and breast-feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

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.
Time Frame: 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.
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.
Time Frame: 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.
Barrier function will be measured at baseline and after 90 minutes of ex vivo stimulation of the colonic biopsies.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Örebro University, Sweden

Collaborators

Harokopio University
Agricultural University of Athens
National Hellenic Research Foundation

Investigators

  • Principal Investigator: Ignacio Rangel, As.Professor, Örebro University, School of Medical Sciences, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2020

Primary Completion (Actual)

September 18, 2020

Study Completion (Actual)

June 17, 2022

Study Registration Dates

First Submitted

June 29, 2022

First Submitted That Met QC Criteria

July 3, 2022

First Posted (Actual)

July 6, 2022

Study Record Updates

Last Update Posted (Actual)

July 6, 2022

Last Update Submitted That Met QC Criteria

July 3, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • T1EDK-03404

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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