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The Association Between Psoriasis and Intestinal Bacterial Population (PIB)

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ClinicalTrials.gov Identifier: NCT02417792
Recruitment Status : Completed
First Posted : April 16, 2015
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
Tel Aviv Medical Center
Information provided by (Responsible Party):
Assuta Hospital Systems

Study Description
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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.

Condition or disease
Psoriasis

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 Design
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Study Type : Observational
Actual Enrollment : 46 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Association Between Psoriasis and Intestinal Bacterial Population
Actual Study Start Date : May 14, 2015
Actual Primary Completion Date : January 6, 2019
Actual Study Completion Date : February 18, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Groups and Cohorts
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Group/Cohort
control
group of healthy participants
Topical psoriasis treatment
Group of patients who are treated with topical medications for psoriasis
Systemic psoriasis treatment
Group of patients who are treated with systematic medications for psoriasis


Outcome Measures
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Primary Outcome Measures :
  1. 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. [ Time Frame: 2 years ]
    To examine whether fecal bacterial populations of psoriasis patients (not treated by enteral medications) are different compared to healthy participants


Biospecimen Retention:   Samples Without DNA
stool

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Both psoriasis patients and healthy participants (as a control group) will be recruited for the study.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02417792


Sponsors and Collaborators
Assuta Hospital Systems
Tel Aviv Medical Center
Investigators
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Principal Investigator: Jonathan Shapiro, Dr. Maccabi Healthcare Services, Israel
More Information
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Publications:

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Responsible Party: Assuta Hospital Systems
ClinicalTrials.gov Identifier: NCT02417792     History of Changes
Other Study ID Numbers: 2
First Posted: April 16, 2015    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: March 2015
Keywords provided by Assuta Hospital Systems:
psoriasis
microbiota
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases