Characterization of Cutaneous Microbiota in the Psoriasis Pathogenesis

Psoriasis Clinical Trial

— MICROBIOTA  

Official title:

Characterization of Cutaneous Microbiota and Evaluation of the Antimicrobial Peptides Roles in the Psoriasis Etiopathogenesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03475914
• Other study ID #: MICROBIOTA
• Status: Completed
• First received: February 15, 2018
• Last updated: March 22, 2018
• Start date: October 13, 2016
• Est. completion date: November 21, 2017

Study information

• Verified date: February 2018
• Source: Istituto Ortopedico Galeazzi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The skin harbors a complex and dynamic microbiota constituted by numerous microorganisms that live in symbiosis with the host. The specific etiology of psoriasis is still not-well understood; nonetheless several studies highlighted that that the skin microbiota could have a pivotal role in the maintenance and/or progression of the disease, acting as microbial predictor of psoriasis however.

The aim of the present study was to characterize the microbiota of cutaneous biopsies associated to guttate and vulgaris psoriasis, both considering lesion and healthy skin belonging to the same psoriatic subject.

Description:

Twelve individuals with guttate psoriasis and 12 individuals with vulgaris psoriasis have been enrolled at Dermatological Unit of IRCCS Galeazzi Institute, Milan.

Patients selected for the psoriasis vulgaris group had a course of disease stable for at least 1 month before collection. The second group presented guttate psoriasis, defined as "eruptive", that is characterized by a rapid appearance and worsening of the clinical presentation within the month preceding the visit.

From each participant, a punch was used to obtain a cutaneous sample from both a lesion and healthy skin area of 2 mm2 belonging to the left gluteus, for a total of 48 biological samples. Participants were selected and included in the study according to the following criteria: i) over 18 years of age; ii) use of a free-preservatives soap with moisturizing function; iii) no use of probiotics; iv) no use of antibiotics; v) no treatment with corticosteroids, biological drugs, methotrexate or retinoids in the month prior the sampling; vi) no use of topical corticosteroids, vitamin D derivatives or phototherapy; vi) no chronic or systemic infections; vii) no cutaneous acute infections; viii) no allergy to pollen, food and drugs ix) no pets. Informed consent was obtained from all subjects.

A metagenomics approach, performed by the use of Ion torrent Personal machine, were used to investigate the bacterial composition of the skin microbiota associated to each samples collected.

After sequencing, the data analysis were focused on the bacterial biodiversity and microbial networks existing in the skin microbiota to evaluate a hypothetical role of bacteria in the complex pathophysiological mechanisms involved in psoriasis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 21, 2017
• Est. primary completion date: June 29, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• over 18 years of age;

• use of a free-preservatives soap with moisturizing function, applied once a day;pets.

Exclusion Criteria:

• no use of probiotics in the month prior the sampling;

• no use of antibiotics in the month prior the sampling;

• no treatment with corticosteroids, biological drugs, methotrexate or retinoids in the month prior the sampling;

• no use of topical corticosteroids, vitamin D derivatives or phototherapy in the month prior the sampling;

• no chronic or systemic infections;

• no cutaneous acute infections during sampling;

• no allergy to pollen, food and drugs

• no pets.

Related Conditions & MeSH terms

• Psoriasis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Galeazzi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the Psoriasis Area and Severity Index (PASI)	It is a measurement of psoriasis severity .	1 year
Secondary	Chao's index	It is a measure of bacterial biodiversity	1 year
Secondary	Microbial abundance	It is a measure of bacterial amount	1 year
Secondary	Spearman's correlation	It a measure of the bacterial interactions	1 year
Secondary	Shannon's index	It is a measure of bacterial biodiversity	At the beginning of the study
Secondary	Simpson's index	It is a measure of bacterial biodiversity	1 year