Psoriatic PatientsNCT04212507
The Gut-Skin Axis Integrity in Psoriatic Patients
An observational study of Psoriatic Patients, run by Assiut University.
Trial summary
Assess two non-invasive markers of intestinal barrier integrity {Claudin-3 and intestinal Fatty acid-binding protein (I-FABP)} in patients with psoriasis and to evaluate the possible relation of these markers with the demographic and clinical data. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Psoriatic Patients
- What is being tested?
- The serum level of Claudin-3 and intestinal Fatty acid binding protein
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 1 Dec 2021
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: psoriatic patients and age and sex-matched healthy volunteers as a control group
Who may be able to join
- psoriatic patients and age and sex-matched healthy volunteers as a control group
Who cannot join
- - History of acute gastrointestinal infection or gastrointestinal surgery during the last 3 months prior to the study
- Intake of probiotics or prebiotics during the last one month.
- Systemic anti-psoriatic treatment in the previous 3 months
- Topical or phototherapy during the last month
- Dietary restrictions during the last 3 months
- Chronic gastrointestinal disorder (celiac disease, inflammatory bowel diseases, irritable bowel disease, food allergies)
Show all 9Show fewer
- Liver cirrhosis
- Cardiac failure
- Any associated skin or systemic illness
Trial locations and contacts
No sites are listed yet.
About this study
Assess two non-invasive markers of intestinal barrier integrity {Claudin-3 and intestinal Fatty acid-binding protein (I-FABP)} in patients with psoriasis and to evaluate the possible relation of these markers with the demographic and clinical data.
Read the detailed description
Psoriasis is a common non-infectious chronic immune-mediated skin disorder that is associated with the considerable physical and social burden .Its estimated prevalence varies globally and is highest in western countries, where it affects around 2-4% of the population The most common form is plaque psoriasis, accounting 90% of all cases and manifesting as sharply demarcated erythematous plaques covered by silvery scales The gut microbiota refers to the complex community of microorganisms, covering more than 1000 different species of bacteria, viruses, fungi, and protozoa.
The gut commensals predominantly aid in nutrient metabolism, drug metabolism, prevention of colonization of pathogenic microorganisms and in intestinal barrier function..
Dysbiosis or alterations in the composition and function of the microbiota has been implicated in the development and progression of various skin diseases. The concept of "gut-skin axis" links the effects of dysbiosis with many skin diseases.
Disruption of the intestinal barrier can cause translocation of bacteria and their endotoxins or metabolites, which further induces or aggravates systemic inflammation The intestinal barrier function is maintained by a lining of enterocytes and tight junctions, sealing the paracellular space between adjacent enterocytes. Intestinal barrier integrity loss can be assessed by evaluation of intestinal epithelial cell damage or tight junction loss Claudins are transmembrane proteins which participate in the formation of tight junctions by binding to the actin cytoskeleton. Blood Claudin- 3 is considered as a useful early non-invasive biomarker of intestinal permeability due to its small size Fatty acid-binding proteins (FABP) are small (14-15 kDa) cytosolic water-soluble proteins, present in mature enterocytes of the small and large intestine... It is also considered a reliable marker of intestinal barrier integrity Psoriasis is a systemic inflammatory disease with complex multifactorial pathogenesis. Recently, considerable interest has been focused on the interaction between the gut microbiome, intestinal barrier and immune system. The so-called 'gut-skin axis' has been suggested to be a key factor and an interesting area of research in the etiopathogenesis of psoriasis with potential attractive therapeutic implications
- Conditions
- Psoriatic Patients
- Being tested
- The serum level of Claudin-3 and intestinal Fatty acid binding protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The serum level of Claudin-3 and intestinal Fatty acid binding proteinDiagnostic test
Also called Complete blood count ,Liver enzymes ,Fasting blood glucose and Serum creatinine level
The serum level of Claudin-3 and intestinal Fatty acid-binding protein between patients with psoriasis and controls Understanding the interplay between microbiota, gut barrier and inflammation may contribute to the development of new methods of preventing onset or exacerbations of psoriasis and new therapeutic approach for psoriasis.
| Study group | Role | What they receive |
|---|---|---|
| 1 | 50 psoriatic patients Receives: Diagnostic Test: The serum level of Claudin-3 and intestinal Fatty acid binding protein | |
| 2 | 30 age and sex-matched healthy volunteers as a control group Receives: Diagnostic Test: The serum level of Claudin-3 and intestinal Fatty acid binding protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the serum level of Claudin-3 and intestinal Fatty acid binding protein between patients with psoriasis and controls
Understanding the interplay between microbiota, gut barrier and inflammation to study the aetiopathogenesis of psoriasis may contribute to the development of new methods of preventing onset or exacerbations of psoriasis and new therapeutic approach for psoriasis.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2019
- Study start1 Oct 2020 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Psoriatic PatientsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Mohammed Hosni Alameldin Mhmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212507
- Sponsor's protocol ID
- the GSAI in Psoriatic Patients
- Status last verified
- Jul 2020
- First submitted
- 24 Dec 2019
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Traks T, Keermann M, Prans E, Karelson M, Loite U, Koks G, Silm H, Koks S, Kingo K. Polymorphisms in IL36G gene are associated with plaque psoriasis. BMC Med Genet. 2019 Jan 11;20(1):10. doi: 10.1186/s12881-018-0742-2.
PubMed 30634937Jandhyala SM, Talukdar R, Subramanyam C, Vuyyuru H, Sasikala M, Nageshwar Reddy D. Role of the normal gut microbiota. World J Gastroenterol. 2015 Aug 7;21(29):8787-803. doi: 10.3748/wjg.v21.i29.8787.
PubMed 26269668Barmeyer C, Fromm M, Schulzke JD. Active and passive involvement of claudins in the pathophysiology of intestinal inflammatory diseases. Pflugers Arch. 2017 Jan;469(1):15-26. doi: 10.1007/s00424-016-1914-6. Epub 2016 Nov 30.
PubMed 27904960Salem I, Ramser A, Isham N, Ghannoum MA. The Gut Microbiome as a Major Regulator of the Gut-Skin Axis. Front Microbiol. 2018 Jul 10;9:1459. doi: 10.3389/fmicb.2018.01459. eCollection 2018.
PubMed 30042740
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Gut-Skin Axis Integrity in Psoriatic Patients
- ClinicalTrials.gov ID
- NCT04212507
- Acronym / sponsor ID
- the GSAI in Psoriatic Patients
- Conditions
- Psoriatic Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 27 Dec 2019 (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.
Assess two non-invasive markers of intestinal barrier integrity {Claudin-3 and intestinal Fatty acid-binding protein (I-FABP)} in patients with psoriasis and to evaluate the possible relation of these markers with the demographic and clinical data.
Detailed description
Psoriasis is a common non-infectious chronic immune-mediated skin disorder that is associated with the considerable physical and social burden .Its estimated prevalence varies globally and is highest in western countries, where it affects around 2-4% of the population The most common form is plaque psoriasis, accounting 90% of all cases and manifesting as sharply demarcated erythematous plaques covered by silvery scales The gut microbiota refers to the complex community of microorganisms, covering more than 1000 different species of bacteria, viruses, fungi, and protozoa.
The gut commensals predominantly aid in nutrient metabolism, drug metabolism, prevention of colonization of pathogenic microorganisms and in intestinal barrier function..
Dysbiosis or alterations in the composition and function of the microbiota has been implicated in the development and progression of various skin diseases. The concept of "gut-skin axis" links the effects of dysbiosis with many skin diseases.
Disruption of the intestinal barrier can cause translocation of bacteria and their endotoxins or metabolites, which further induces or aggravates systemic inflammation The intestinal barrier function is maintained by a lining of enterocytes and tight junctions, sealing the paracellular space between adjacent enterocytes. Intestinal barrier integrity loss can be assessed by evaluation of intestinal epithelial cell damage or tight junction loss Claudins are transmembrane proteins which participate in the formation of tight junctions by binding to the actin cytoskeleton. Blood Claudin- 3 is considered as a useful early non-invasive biomarker of intestinal permeability due to its small size Fatty acid-binding proteins (FABP) are small (14-15 kDa) cytosolic water-soluble proteins, present in mature enterocytes of the small and large intestine... It is also considered a reliable marker of intestinal barrier integrity Psoriasis is a systemic inflammatory disease with complex multifactorial pathogenesis. Recently, considerable interest has been focused on the interaction between the gut microbiome, intestinal barrier and immune system. The so-called 'gut-skin axis' has been suggested to be a key factor and an interesting area of research in the etiopathogenesis of psoriasis with potential attractive therapeutic implications
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Diagnostic Test: The serum level of Claudin-3 and intestinal Fatty acid binding protein50 psoriatic patients |
| 2 | – | Diagnostic Test: The serum level of Claudin-3 and intestinal Fatty acid binding protein30 age and sex-matched healthy volunteers as a control group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- psoriatic patients and age and sex-matched healthy volunteers as a control group
Key inclusion criteria (1 listed)
- psoriatic patients and age and sex-matched healthy volunteers as a control group
Key exclusion criteria (9 listed)
- - History of acute gastrointestinal infection or gastrointestinal surgery during the last 3 months prior to the study
- Intake of probiotics or prebiotics during the last one month.
- Systemic anti-psoriatic treatment in the previous 3 months
- Topical or phototherapy during the last month
- Dietary restrictions during 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 |
|---|---|---|
| The serum level of Claudin-3 and intestinal Fatty acid binding proteinAlso: Complete blood count ,Liver enzymes ,Fasting blood glucose and Serum creatinine levelThe serum level of Claudin-3 and intestinal Fatty acid-binding protein between patients with psoriasis and controls Understanding the interplay between microbiota, gut barrier and inflammation may contribute to the development of new methods of preventing onset or exacerbations of psoriasis and new therapeutic approach for psoriasis. | Diagnostic test | 1, 2 |
Primary outcome
Compare the serum level of Claudin-3 and intestinal Fatty acid binding protein between patients with psoriasis and controls
Time frame: Baseline
Understanding the interplay between microbiota, gut barrier and inflammation to study the aetiopathogenesis of psoriasis may contribute to the development of new methods of preventing onset or exacerbations of psoriasis and new therapeutic approach for psoriasis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Background: PubMed 30634937Traks T, Keermann M, Prans E, Karelson M, Loite U, Koks G, Silm H, Koks S, Kingo K. Polymorphisms in IL36G gene are associated with plaque psoriasis. BMC Med Genet. 2019 Jan 11;20(1):10. doi: 10.1186/s12881-018-0742-2.
- Background: PubMed 26269668Jandhyala SM, Talukdar R, Subramanyam C, Vuyyuru H, Sasikala M, Nageshwar Reddy D. Role of the normal gut microbiota. World J Gastroenterol. 2015 Aug 7;21(29):8787-803. doi: 10.3748/wjg.v21.i29.8787.
- Background: PubMed 27904960Barmeyer C, Fromm M, Schulzke JD. Active and passive involvement of claudins in the pathophysiology of intestinal inflammatory diseases. Pflugers Arch. 2017 Jan;469(1):15-26. doi: 10.1007/s00424-016-1914-6. Epub 2016 Nov 30.
- Background: PubMed 30042740Salem I, Ramser A, Isham N, Ghannoum MA. The Gut Microbiome as a Major Regulator of the Gut-Skin Axis. Front Microbiol. 2018 Jul 10;9:1459. doi: 10.3389/fmicb.2018.01459. eCollection 2018.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriatic Patients, run by Assiut University.
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 1 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amal Mhmoud, MD (+201026122444, amal.alameldin@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the serum level of Claudin-3 and intestinal Fatty acid binding protein between patients with psoriasis and controls (time frame: Baseline). 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 NCT04212507, which also lists 4 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 9 Jul 2020.