PsoriasisPIBNCT02417792
The Association Between Psoriasis and Intestinal Bacterial Population
An observational study of Psoriasis, run by Assuta Hospital Systems.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 14 May 2015to 18 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Both psoriasis patients and healthy participants (as a control group) will be recruited for the study.
Who may be able to join
- Dermal psoriasis patients diagnosed by a dermatologist.
Who cannot join
- Treatment with antibiotics or probiotics within the prior 3 months.
- incapable of signing an inform concent.
About this study
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.
Read the 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.
- Conditions
- Psoriasis
- Keywords
- psoriasis, microbiota
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study start14 May 2015
- Primary completion6 Jan 2019
- Study completion18 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assuta Hospital Systems
- Sponsor type
- University, hospital or other
- Collaborators
- Tel Aviv Medical Center
- Responsible party
- Sponsor
- Investigators
- Jonathan Shapiro, Dr., Principal investigator, Maccabi Healthcare Services, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417792
- Sponsor's protocol ID
- 2
- Acronym
- PIB
- Status last verified
- Mar 2015
- First submitted
- 13 Apr 2015
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 23084703Shaw 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.
PubMed 20940708Caporaso 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.
PubMed 20383131Edgar 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.
PubMed 20709691Henseler 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.
PubMed 4056119
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Psoriasis and Intestinal Bacterial Population
- ClinicalTrials.gov ID
- NCT02417792
- Acronym / sponsor ID
- PIB / 2
- Conditions
- Psoriasis
- Keywords
- psoriasis, microbiota
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Assuta Hospital SystemsUniversity, hospital or other
- Collaborators
- Tel Aviv Medical Center
- Study start
- 14 May 2015 (actual)
- Primary completion
- 6 Jan 2019 (actual)
- Study completion
- 18 Feb 2019 (actual)
- First posted
- 16 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Both psoriasis patients and healthy participants (as a control group) will be recruited for the study.
Key inclusion criteria (1 listed)
- Dermal psoriasis patients diagnosed by a dermatologist.
Key exclusion criteria (2 listed)
- Treatment with antibiotics or probiotics within the prior 3 months.
- incapable of signing an inform concent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Background: PubMed 23084703Shaw 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.
- Background: PubMed 20940708Shaw 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.
- Background: PubMed 20383131Caporaso 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.
- Background: PubMed 20709691Edgar 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.
- Background: PubMed 4056119Henseler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Shapiro, Dr. principal investigator
Maccabi Healthcare Services, Israel
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Assuta Hospital Systems.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02417792, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.