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The Association Between Psoriasis and Intestinal Bacterial Population (PIB)

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ClinicalTrials.gov Identifier: NCT02417792
Recruitment Status : Completed
First Posted : April 16, 2015
Last Update Posted : September 25, 2019
Sponsor:
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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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