The Gut-Skin Axis Integrity in Psoriatic Patients

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.

Study Overview

• Status: Unknown
• Conditions: Psoriatic Patients
• Intervention / Treatment: Diagnostic test: The serum level of Claudin-3 and intestinal Fatty acid binding protein

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 Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Amal Mhmoud, MD; Phone Number: +201026122444; Email: amal.alameldin@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

psoriatic patients and age and sex-matched healthy volunteers as a control group

Description

Inclusion Criteria:

• psoriatic patients and age and sex-matched healthy volunteers as a control group

Exclusion Criteria:

• - 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)
• Liver cirrhosis
• Cardiac failure
• Any associated skin or systemic illness

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; 50 psoriatic patients	Diagnostic test: The serum level of Claudin-3 and intestinal Fatty acid binding protein; 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.; Other Names: Complete blood count ,Liver enzymes ,Fasting blood glucose and Serum creatinine level
2; 30 age and sex-matched healthy volunteers as a control group	Diagnostic test: The serum level of Claudin-3 and intestinal Fatty acid binding protein; 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.; Other Names: Complete blood count ,Liver enzymes ,Fasting blood glucose and Serum creatinine level

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General 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.
• Jandhyala 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.
• Barmeyer 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.
• Salem 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2020
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: December 24, 2019
• First Submitted That Met QC Criteria: December 24, 2019
• First Posted (ACTUAL): December 27, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: the GSAI in Psoriatic Patients

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No