The Association Between Psoriasis and Intestinal Bacterial Population

Completed

• Conditions: Psoriasis

• Registration Number: NCT02417792
• Lead Sponsor: Assuta Hospital Systems

Brief Summary

At least 20 psoriasis patients will be compared to at least 20 participants without psoriasis Bacterial genomic DNA will be extracted from stool samples of participants. The intestinal bacterial populations will be compared in order to examine whether there are differences between the groups.

Detailed Description

Intestinal bacterial population has a significant influence on health and sickness conditions. It affects the development and the function of the immune system (Th2, Th1 or Th17) by bacterial protein expression and by the composition of the bacterial population.

Psoriasis is an immune related dermal disease. The trigger for this disease is currently unknown but, it is possible that intestinal bacteria are a factor in its development.

Study design:

Participants will be divided into 3 groups:

* Psoriasis patients treated with topical medications

* Psoriasis patients treated with IV or sub-cutaneous medications (e.g biological medications)

* Healthy participants (control group) Bacterial genomic DNA will be extracted from stool samples of participants. The intestinal bacterial populations will be compared in order to examine whether there are differences between the groups.

Study Timeline

• Status Verified: 2015-03
• Study First Submitted: 2015-04-13
• Study First Submitted QC: 2015-04-15
• Study First Posted: 2015-04-16
• Study Start: 2015-05-14
• Primary Completion: 2019-01-06
• Study Completion: 2019-02-18
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Dermal psoriasis patients diagnosed by a dermatologist.

Exclusion Criteria

• Treatment with antibiotics or probiotics within the prior 3 months.
• incapable of signing an inform concent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A significant change (P<0.05) in enteric bacterial composition of psoriasis patients (n=20) vs controls (n=20) as assessed by alpha diversity, beta diversity and taxonomic analysis.	2 years	To examine whether fecal bacterial populations of psoriasis patients (not treated by enteral medications) are different compared to healthy participants