Szeged University is recruiting patients for the clinical trial of Evaluation of the Effect of Sulphur Mineral, Thermal Water on Skin Microbiome in Plaque Psoriasis, a Pilot Study.
In this study the effects of balneotherapy in Lake Hévíz, 36℃ sulphur, carbonate, calcium, magnesium, hydrogen carbonate and very light radon-content thermal, mineral water on skin microbiome and Psoriasis Area and Severity Index (PASI) in patients with plaque psoriasis
Psoriasis is a chronic inflammatory skin disease. It is associated with several important medical conditions, including psoriatic arthritis, and cardiometabolic syndrome. Its most common form, chronic plaque.The aim of this study is to evaluate how Lake Hévíz sulphur thermal mineral water therapy influences the composition of microbial communities that colonizes skin in patients with psoriasis, and the extent and severity of skin symptoms of psoriasis.
The planned participants number is 16 outpatients between 18 and 70 years of age with mild to moderate psoriasis. The balneotherapy takes place in Lake Hévíz, five times a week for three weeks.
The researchers plan that July 25, 2021 will be the study start date. The indicative completion of the clinical trial will be expected in August 15, 2022.
Among primary outcome measures are the 2. Change in microbiota diversity before and after balneotherapy treatment and Change in alpha diversity before and after treatment:to compare normal samples before and after treatment, to compare psoriasis samples before and after treatment and the comparison of normal and psoriasis samples before treatment.Differences in genus abundances to determine with the core function of the microbiome R package (Lahti et al., 2019), with detection 100 and prevalence 0.1.
The study will take place at the Tamas Bender, Budapest, Hungary; Ágota Kulisch, MD, PhD, Hévíz, Hungary.
The page dedicated to this clinical trial can be found here: orhttps://ichgcp.net/clinical-trials-registry/NCT05431959 https://clinicaltrials.gov/ct2/show/NCT05431959.