Psoriasis
Conditions
Keywords
mild to moderate, probiotic
Brief summary
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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTProbiotic
one capsule per day, containing the probiotic along with the patient's customary psoriasis treatment (excluding systemic treatments)
DIETARY_SUPPLEMENTPlacebo
one capsule per day, containing the placebo, along with the patient's customary psoriasis treatment (excluding systemic treatments)
Sponsors
Korott, S.L.
Biopolis S.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with a PASI score reduction higher than 75% | twelve weeks | Number of patients with a PASI score reduction higher than 75% from the basal value |
| Time to reach a reduction in the PASI score higher than 75% | twelve weeks | time to reach a reduction in the PASI score higher than 75% in from the basal value |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of patients that remains in analytical remission | twelve weeks | number of patients that remains in analytical remission (that is, that maintain said inflammation markers in normal values) |
| Average time to reach the clinical remission | twelve weeks | Average time to reach the clinical remission, with no activity (PASI score lower than 6) from the treatment beginning |
| Number of patients with an improvement in the PGA score | Twelve weeks | Number of patients with an improvement in the PGA score at the end of the study with regard of basal values |
| Number of patients with mild, moderate or severe adverse events | twelve weeks | Number of patients with mild, moderate or severe adverse events attributable to regular treatment to psoriasis or to probiotic. |
| Differences among any of the inflammation markers | twelve weeks | — |
Countries
Spain
Outcome results
None listed