The Association Between Psoriasis and Intestinal Bacterial Population

NCT ID: NCT02417792

Last Updated: 2019-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-14

Study Completion Date

2019-02-18

Brief Summary

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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

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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.

Conditions

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Psoriasis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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control

group of healthy participants

No interventions assigned to this group

Topical psoriasis treatment

Group of patients who are treated with topical medications for psoriasis

No interventions assigned to this group

Systemic psoriasis treatment

Group of patients who are treated with systematic medications for psoriasis

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tel Aviv Medical Center

OTHER

Sponsor Role collaborator

Assuta Hospital Systems

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan Shapiro, Dr.

Role: PRINCIPAL_INVESTIGATOR

Maccabi Healthcare Services, Israel

References

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Shaw SY, Blanchard JF, Bernstein CN. Association between early childhood otitis media and pediatric inflammatory bowel disease: an exploratory population-based analysis. J Pediatr. 2013 Mar;162(3):510-4. doi: 10.1016/j.jpeds.2012.08.037. Epub 2012 Oct 17.

Reference Type BACKGROUND
PMID: 23084703 (View on PubMed)

Shaw SY, Blanchard JF, Bernstein CN. Association between the use of antibiotics in the first year of life and pediatric inflammatory bowel disease. Am J Gastroenterol. 2010 Dec;105(12):2687-92. doi: 10.1038/ajg.2010.398. Epub 2010 Oct 12.

Reference Type BACKGROUND
PMID: 20940708 (View on PubMed)

Caporaso JG, Kuczynski J, Stombaugh J, Bittinger K, Bushman FD, Costello EK, Fierer N, Pena AG, Goodrich JK, Gordon JI, Huttley GA, Kelley ST, Knights D, Koenig JE, Ley RE, Lozupone CA, McDonald D, Muegge BD, Pirrung M, Reeder J, Sevinsky JR, Turnbaugh PJ, Walters WA, Widmann J, Yatsunenko T, Zaneveld J, Knight R. QIIME allows analysis of high-throughput community sequencing data. Nat Methods. 2010 May;7(5):335-6. doi: 10.1038/nmeth.f.303. Epub 2010 Apr 11. No abstract available.

Reference Type BACKGROUND
PMID: 20383131 (View on PubMed)

Edgar RC. Search and clustering orders of magnitude faster than BLAST. Bioinformatics. 2010 Oct 1;26(19):2460-1. doi: 10.1093/bioinformatics/btq461. Epub 2010 Aug 12.

Reference Type BACKGROUND
PMID: 20709691 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 4056119 (View on PubMed)

Other Identifiers

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2

Identifier Type: -

Identifier Source: org_study_id

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