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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Fermented product of Pleurotus eryngii mushroom

• Registration Number: NCT05446610
• Lead Sponsor: Örebro University, Sweden

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.

Study Timeline

• Study Start: 2020-03-17
• Primary Completion: 2020-09-18
• Study Completion: 2022-06-17
• Study First Submitted: 2022-06-29
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-03
• Last Update Submitted: 2022-07-03
• Study First Posted: 2022-07-06
• Last Update Posted: 2022-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gut barrier function treatments	Fermented product of Pleurotus eryngii mushroom	Stressor, fibre, combination of treatments.

Primary Outcome Measures

Name	Time	Method
Change from baseline of barrier function (paracellular permeability) after 90 minutes of ex vivo stimulation of the colonic biopsies.	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.
Change from baseline of barrier function (transcellular permeability) after 90 minutes of ex vivo stimulation of the colonic biopsies.	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.

Trial Locations

Locations (1)

Campus USÖ; 🇸🇪 Örebro, Sweden