HealthyFUNglucanNCT05446610
Investigating Effects in Intestinal Permeability of Rich in Beta-glucans Pleurotus Eryngii Mushrooms Fermentation Supernatants: an Ex-vivo Study
A study testing Fermented product of Pleurotus eryngii mushroom in people with Healthy, run by Örebro University, Sweden at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fermented product of Pleurotus eryngii mushroom
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- 17 Mar 2020to 17 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Novel Functional Food Enriched With Beta-glucans Isolated From Edible Mushrooms of Greek Habitats
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Fermented product of Pleurotus eryngii mushroom
- Keywords
- paracellular permeability, transcellular permability, Pleurotus eryngii, beta glucan, prebiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented product of Pleurotus eryngii mushroomOther
I Stimulation of human colonic biopsies with the fermented product of Pleurotus eryngii mushroom
| Study group | Role | What they receive |
|---|---|---|
| Gut barrier function treatments | Experimental | Stressor, fibre, combination of treatments. Receives: Other: Fermented product of Pleurotus eryngii mushroom |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Barrier function will be measured at baseline and after 90 minutes of ex vivo stimulation of the colonic biopsies.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start17 Mar 2020
- Primary completion18 Sep 2020
- Study completion17 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Harokopio University, Agricultural University of Athens, National Hellenic Research Foundation
- Responsible party
- Sponsor
- Investigators
- Ignacio Rangel, As.Professor, Principal investigator, Örebro University, School of Medical Sciences, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446610
- Sponsor's protocol ID
- T1EDK-03404
- Acronym
- FUNglucan
- Status last verified
- Jul 2022
- First submitted
- 29 Jun 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32570735Boulaka 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.
PubMed 32759726Saxami 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.
PubMed 34683391
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Novel Functional Food Enriched With Beta-glucans Isolated From Edible Mushrooms of Greek Habitats
- ClinicalTrials.gov ID
- NCT05446610
- Acronym / sponsor ID
- FUNglucan / T1EDK-03404
- Conditions
- Healthy
- Keywords
- paracellular permeability, transcellular permability, Pleurotus eryngii, beta glucan, prebiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Collaborators
- Harokopio University, Agricultural University of Athens, National Hellenic Research Foundation
- Study start
- 17 Mar 2020 (actual)
- Primary completion
- 18 Sep 2020 (actual)
- Study completion
- 17 Jun 2022 (actual)
- First posted
- 6 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gut barrier function treatments | Experimental | Other: Fermented product of Pleurotus eryngii mushroomStressor, fibre, combination of treatments. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fermented product of Pleurotus eryngii mushroomI Stimulation of human colonic biopsies with the fermented product of Pleurotus eryngii mushroom | Other | Gut barrier function treatments |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Results publication: PubMed 32570735Mitsou 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.
- Results publication: PubMed 32759726Boulaka 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.
- Results publication: PubMed 34683391Saxami 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.
- Research center websiteLink provided by the sponsor.
- Description Project's official websiteLink provided by the sponsor.
- Description Project's official facebook websiteLink provided by the sponsor.
- Description Project's official instagram websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ignacio Rangel, As.Professor principal investigator
Örebro University, School of Medical Sciences, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fermented product of Pleurotus eryngii mushroom in people with Healthy, run by Örebro University, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05446610, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.