The Association Between Psoriasis and Intestinal Bacterial Population

Psoriasis Clinical Trial

— PIB  

Official title:

The Association Between Psoriasis and Intestinal Bacterial Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02417792
• Other study ID #: 2
• Status: Completed
• Start date: May 14, 2015
• Est. completion date: February 18, 2019

Study information

• Verified date: March 2015
• Source: Assuta Hospital Systems
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 18, 2019
• Est. primary completion date: January 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Assuta Hospital Systems	Tel Aviv Medical Center

References & Publications (5)

Caporaso JG, Kuczynski J, Stombaugh J, Bittinger K, Bushman FD, Costello EK, Fierer N, Peña 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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