The Association Between Psoriasis and Intestinal Bacterial Population (PIB)

• ClinicalTrials.gov Identifier: NCT02417792
• Recruitment Status: Completed
• First Posted: April 16, 2015
• Last Update Posted: September 25, 2019
• Sponsor: Assuta Hospital Systems
• Collaborator: Tel Aviv Medical Center
• Information provided by (Responsible Party): Assuta Hospital Systems

Tracking Information

• First Submitted Date: April 13, 2015
• First Posted Date: April 16, 2015
• Last Update Posted Date: September 25, 2019
• Actual Study Start Date: May 14, 2015
• Actual Primary Completion Date: January 6, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 16, 2015)

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

• Original Primary Outcome Measures (submitted: April 15, 2015): To examine whether fecal bacterial populations of psoriasis patients (not treated by enteral medications) are different compared to healthy participants [ Time Frame: 2 years ]
• Change History: Complete list of historical versions of study NCT02417792 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Association Between Psoriasis and Intestinal Bacterial Population
• Official Title: The Association Between Psoriasis and Intestinal Bacterial Population
• 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.

Detailed 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.

• Study Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

stool

• Sampling Method: Non-Probability Sample
• Study Population: Both psoriasis patients and healthy participants (as a control group) will be recruited for the study.
• Condition: Psoriasis
• Intervention: Not Provided

Study Groups/Cohorts

• 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

Publications *

• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 24, 2019): 46
• Original Estimated Enrollment (submitted: April 15, 2015): 40
• Actual Study Completion Date: February 18, 2019
• Actual Primary Completion Date: January 6, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02417792
• Other Study ID Numbers: 2
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Assuta Hospital Systems
• Study Sponsor: Assuta Hospital Systems
• Collaborators: Tel Aviv Medical Center

Investigators

• Principal Investigator: Jonathan Shapiro, Dr.; Maccabi Healthcare Services, Israel

• PRS Account: Assuta Hospital Systems
• Verification Date: March 2015