The Association Between Psoriasis and Intestinal Bacterial Population
PIB
1 other identifier
observational
46
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2015
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2015
CompletedFirst Posted
Study publicly available on registry
April 16, 2015
CompletedStudy Start
First participant enrolled
May 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 18, 2019
CompletedSeptember 25, 2019
March 1, 2015
3.7 years
April 13, 2015
September 24, 2019
Conditions
Keywords
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
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
- Assuta Hospital Systemslead
- Tel Aviv Medical Centercollaborator
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: 23084703BACKGROUNDShaw 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: 20940708BACKGROUNDCaporaso 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: 20383131BACKGROUNDEdgar 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: 20709691BACKGROUNDHenseler 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
stool
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Shapiro, Dr.
Maccabi Healthcare Services, Israel
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