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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Double Blind, Randomized, Placebo-Controlled Intervention Study to Evaluate the Effectiveness and Safety of a Treatment With a Probiotic in Adult Patients Diagnosed With Mild to Moderate Plaque Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Dietary Supplement: Probiotic
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotic<br>one capsule per day, containing the probiotic along with the patient's customary psoriasis treatment (excluding systemic treatments) | Dietary Supplement: Probiotic<br>* one capsule per day, containing the probiotic along with the patient's customary psoriasis treatment (excluding systemic treatments)<br>|
| Placebo Comparator: Placebo<br>one capsule per day, containing the placebo, along with the patient's customary psoriasis treatment (excluding systemic treatments) | Dietary Supplement: Placebo<br>* one capsule per day, containing the placebo, along with the patient's customary psoriasis treatment (excluding systemic treatments)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with a PASI score reduction higher than 75% | Number of patients with a PASI score reduction higher than 75% from the basal value | twelve weeks | 
| Time to reach a reduction in the PASI score higher than 75% | time to reach a reduction in the PASI score higher than 75% in from the basal value | twelve weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average time to reach the clinical remission | Average time to reach the clinical remission, with no activity (PASI score lower than 6) from the treatment beginning | twelve weeks | 
| Differences among any of the inflammation markers |  | twelve weeks | 
| number of patients that remains in analytical remission | number of patients that remains in analytical remission (that is, that maintain said inflammation markers in normal values) | twelve weeks | 
| Number of patients with mild, moderate or severe adverse events | Number of patients with mild, moderate or severe adverse events attributable to regular treatment to psoriasis or to probiotic. | twelve weeks | 
| Number of patients with an improvement in the PGA score | Number of patients with an improvement in the PGA score at the end of the study with regard of basal values | Twelve weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mild to moderate, probiotic