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Completed

NCT Number: NCT05446610

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Campus USÖ

Örebro, 703 62, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fermented product of Pleurotus eryngii mushroom

Other

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

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Örebro University, Sweden

Other

Collaborators

  • Agricultural University of Athens
  • Harokopio University
  • National Hellenic Research Foundation

Registry information

Official study title

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

Acronym: FUNglucan

Important dates

Study start
2020
Primary completion
2020
Study completion
2022
First posted
Jul 6, 2022
Registry last updated
Jul 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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