Intervention Study to Evaluate a Probiotic in Mild to Moderate Psoriasis Patients

Biopolis

Status

Completed

Conditions

Psoriasis

Treatments

Dietary Supplement: Probiotic

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02576197

PSO/PRO 2

Details and patient eligibility

About

This study evaluates the efficiency of a probiotic as a coadjuvant in the conventional treatment of mild to moderate plaque psoriasis. Half of the patients will receive the probiotic per os, while the other half will receive a placebo; all patients will continue with their regular psoriasis treatment.

Full description

The aim of this study is to evaluate the efficiency of a probiotic in capsules as a coadjuvant in the conventional treatment of mild to moderate plaque psoriasis. The efficiency is measured as the reduction in the PASI score in the patients (18 to 70 years old) included in the study, with a mild to moderate plaque psoriasis treated exclusively with topic treatment in the moment of being included in the study. Apart from the PASI score reduction from the first visit to the end of the study, the ability to reduce the improvement time in those patients will be evaluated as well. Additionally, the following markers of systemic inflammation are also compared between both active and placebo branches: Tumor necrosis factor, Interferon-gamma, interleukines 1b, 12, 16 and 23.

Enrollment

98 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Plaque psoriasis diagnosed at least a year before the beginning of the treatment.
Mild to moderate Psoriasis with a PASI score higher than 6 with no new flare-up in the previous four week to the beginning of the treatment.
Patients capable of giving their informed consent to their participation in the study
For women in fertile age, a negative pregnancy test before the beginning of the treatment, and the use of active contraceptive methods is required

Exclusion criteria

Patients suffering from Crohn disease, hepatic cirrhosis, morbid obesity, VIH-positive or any other active infection.
The use of any systemic, oral or parenteral psoriasis treatment in the last three months.
The use of any antibiotic, probiotic or/and prebiotic in the last two weeks.
The use of natural product with proved efficiency on health (apart from multivitamin and multimineral products)
Any hepatic, renal, endocrine, respiratory, neurologic or cardiovascular disease.
Pregnancy and breastfeeding.
Patients not being capable of giving their informed consent or not being capable of following the study conditions.