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OpenTrials
Completed

NCT Number: NCT02417792

The Association Between Psoriasis and Intestinal Bacterial Population

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Assuta Hospital Systems

Other

Collaborators

  • Tel Aviv Medical Center

Registry information

Acronym: PIB

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Apr 16, 2015
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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