Clinical trial NCT05446610: Investigating Effects in Intestinal Permeability of Rich in Beta-glucans Pleurotus Eryngii Mushrooms Fermentation Supernatants: an Ex-vivo Study
Official title: Development of a Novel Functional Food Enriched With Beta-glucans Isolated From Edible Mushrooms of Greek Habitats
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: paracellular permeability
transcellular permability
Pleurotus eryngii
beta glucan
prebiotic
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
Collaborators: name: Harokopio University
name: Agricultural University of Athens
name: National Hellenic Research Foundation
First posted: 2022-07-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline of barrier function (paracellular permeability) after 90 minutes of ex vivo stimulation of the colonic biopsies.
timeFrame: Barrier function will be measured at baseline and after 90 minutes of ex vivo stimulation of the colonic biopsies.
measure: Change from baseline of barrier function (transcellular permeability) after 90 minutes of ex vivo stimulation of the colonic biopsies.
timeFrame: Barrier function will be measured at baseline and after 90 minutes of ex vivo stimulation of the colonic biopsies.
Secondary outcomes:
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Campus USÖ
Study officials:
affiliation: Örebro University, School of Medical Sciences, Sweden
name: Ignacio Rangel, As.Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mitsou EK, Saxami G, Stamoulou E, Kerezoudi E, Terzi E, Koutrotsios G, Bekiaris G, Zervakis GI, Mountzouris KC, Pletsa V, Kyriacou A. Effects of Rich in Beta-Glucans Edible Mushrooms on Aging Gut Microbiota Characteristics: An In Vitro Study. Molecules. 2020 Jun 18;25(12):2806. doi: 10.3390/molecules25122806.
citation: Boulaka A, Christodoulou P, Vlassopoulou M, Koutrotsios G, Bekiaris G, Zervakis GI, Mitsou EK, Saxami G, Kyriacou A, Zervou M, Georgiadis P, Pletsa V. Genoprotective Properties and Metabolites of beta-Glucan-Rich Edible Mushrooms Following Their In Vitro Fermentation by Human Faecal Microbiota. Molecules. 2020 Aug 4;25(15):3554. doi: 10.3390/molecules25153554.
citation: Saxami G, Kerezoudi EN, Mitsou EK, Koutrotsios G, Zervakis GI, Pletsa V, Kyriacou A. Fermentation Supernatants of Pleurotus eryngii Mushroom Ameliorate Intestinal Epithelial Barrier Dysfunction in Lipopolysaccharide-Induced Caco-2 Cells via Upregulation of Tight Junctions. Microorganisms. 2021 Oct 1;9(10):2071. doi: 10.3390/microorganisms9102071.