- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02417792
The Association Between Psoriasis and Intestinal Bacterial Population (PIB)
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
---|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
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.
Tidsramme: 2 years
|
To examine whether fecal bacterial populations of psoriasis patients (not treated by enteral medications) are different compared to healthy participants
|
2 years
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jonathan Shapiro, Dr., Maccabi Healthcare Services, Israel
Publikationer og nyttige links
Generelle publikationer
- Caporaso 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.
- 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.
- 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.
- 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. doi: 10.1016/s0190-9622(85)70188-0.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2
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Kliniske forsøg med Psoriasis
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ProgenaBiomeRekrutteringPsoriasis | Psoriasis Vulgaris | Psoriasis i hovedbunden | Psoriatisk plak | Psoriasis Universalis | Psoriasis ansigt | Psoriasis negl | Psoriasis Diffusa | Psoriasis Punctata | Psoriasis Palmaris | Psoriasis Circinata | Psoriasis Annularis | Psoriasis Genital | Psoriasis GeographicaForenede Stater
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Clin4allRekrutteringPsoriasis i hovedbunden | Psoriasis negl | Psoriasis Palmaris | Psoriasis Genital | Psoriasis PlantarisFrankrig
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Centre of Evidence of the French Society of DermatologyRekrutteringPsoriasis | Psoriasis Vulgaris | Psoriasis i hovedbunden | Psoriatisk plak | Psoriasis Universalis | Psoriasis Palmaris | Psoriatisk erytrodermi | Psoriasis negl | Psoriasis Guttate | Psoriasis omvendt | Psoriasis pustulærFrankrig
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AmgenAfsluttetPsoriasis-Psoriasis | Plaque-type psoriasisForenede Stater
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Innovaderm Research Inc.AfsluttetPsoriasis i hovedbunden | Pustulær Palmo-plantar Psoriasis | Ikke-pustulær Palmo-plantar Psoriasis | Albue Psoriasis | Psoriasis i underbenetCanada
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UCB Biopharma S.P.R.L.AfsluttetModerat til svær psoriasis | Generaliseret pustulær psoriasis og erytrodermisk psoriasisJapan
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TakedaRekrutteringGeneraliseret pustulær psoriasis | Erytrodermisk psoriasisJapan
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PfizerAfsluttetPsoriasis Vulgaris | Pustuløs psoriasis | Psoriasis Arthropathica | Erytrodermisk psoriasisJapan
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Janssen Pharmaceutical K.K.RekrutteringGeneraliseret pustulær psoriasis | Erytrodermisk psoriasisJapan
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Eli Lilly and CompanyAfsluttetGeneraliseret pustulær psoriasis | Erytrodermisk psoriasisJapan