NCT02417792

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2015

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 16, 2015

Completed
28 days until next milestone

Study Start

First participant enrolled

May 14, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2019

Completed
Last Updated

September 25, 2019

Status Verified

March 1, 2015

Enrollment Period

3.7 years

First QC Date

April 13, 2015

Last Update Submit

September 24, 2019

Conditions

Keywords

psoriasismicrobiota

Outcome Measures

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.

    To examine whether fecal bacterial populations of psoriasis patients (not treated by enteral medications) are different compared to healthy participants

    2 years

Study Arms (3)

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Both psoriasis patients and healthy participants (as a control group) will be recruited for the study.

You may qualify if:

  • Dermal psoriasis patients diagnosed by a dermatologist.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 23084703BACKGROUND
  • 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.

    PMID: 20940708BACKGROUND
  • 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.

    PMID: 20383131BACKGROUND
  • 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.

    PMID: 20709691BACKGROUND
  • 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.

    PMID: 4056119BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

stool

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jonathan Shapiro, Dr.

    Maccabi Healthcare Services, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2015

First Posted

April 16, 2015

Study Start

May 14, 2015

Primary Completion

January 6, 2019

Study Completion

February 18, 2019

Last Updated

September 25, 2019

Record last verified: 2015-03