Clinical trial NCT02417792: The Association Between Psoriasis and Intestinal Bacterial Population
Official title: The Association Between Psoriasis and Intestinal Bacterial Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: psoriasis
microbiota
Lead sponsor: Assuta Hospital Systems
Sponsor class: OTHER
Collaborators: name: Tel Aviv Medical Center
First posted: 2015-04-16
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Both psoriasis patients and healthy participants (as a control group) will be recruited for the study.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Maccabi Healthcare Services, Israel
name: Jonathan Shapiro, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Henseler T, Christophers E. Psoriasis of early and late onset: characterization of two types of psoriasis vulgaris. J Am Acad Dermatol. 1985 Sep;13(3):450-6. doi: 10.1016/s0190-9622(85)70188-0.