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

Healthy Clinical Trial

— FUNglucan  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05446610
• Other study ID #: T1EDK-03404
• Status: Completed
• Phase: N/A
• Start date: March 17, 2020
• Est. completion date: June 17, 2022

Study information

• Verified date: July 2022
• Source: Örebro University, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 17, 2022
• Est. primary completion date: September 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Fermented product of Pleurotus eryngii mushroom
I Stimulation of human colonic biopsies with the fermented product of Pleurotus eryngii mushroom

Locations

Country	Name	City	State
Sweden	Campus USÖ	Örebro

Sponsors (4)

Lead Sponsor	Collaborator
Örebro University, Sweden	Agricultural University of Athens, Harokopio University, National Hellenic Research Foundation

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

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 ß-Glucan-Rich Edible Mushrooms Following Their In Vitro Fer — View 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 ?-Glucans Edible Mushrooms on Aging Gut Microbiota Characteristics: An In Vitro Study. Molecules. 2020 — View 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 o — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.

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