NCT05446610

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Mar 2020

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2020

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2022

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 6, 2022

Completed
Last Updated

July 6, 2022

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

June 29, 2022

Last Update Submit

July 3, 2022

Conditions

Healthy

Keywords

paracellular permeabilitytranscellular permabilityPleurotus eryngiibeta glucanprebiotic

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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.

Study Arms (1)

Gut barrier function treatments

EXPERIMENTAL

Stressor, fibre, combination of treatments.

Other: Fermented product of Pleurotus eryngii mushroom

Interventions

Fermented product of Pleurotus eryngii mushroomOTHER

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

Gut barrier function treatments

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Campus USÖ

Örebro, 703 62, Sweden

Location

Related Publications (3)

  • 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.

    PMID: 32570735RESULT

  • 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.

    PMID: 32759726RESULT

  • 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.

    PMID: 34683391RESULT

Related Links

Study Officials

  • Ignacio Rangel, As.Professor

    Örebro University, School of Medical Sciences, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2022

First Posted

July 6, 2022

Study Start

March 17, 2020

Primary Completion

September 18, 2020

Study Completion

June 17, 2022

Last Updated

July 6, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)