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| Name | Class |
|---|---|
| Korott, S.L. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Active Comparator | one capsule per day, containing the probiotic along with the patient's customary psoriasis treatment (excluding systemic treatments) |
|
| Placebo | Placebo Comparator | one capsule per day, containing the placebo, along with the patient's customary psoriasis treatment (excluding systemic treatments) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | one capsule per day, containing the probiotic along with the patient's customary psoriasis treatment (excluding systemic treatments) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vicente Navarro-López, MD | Universidad Católica San Antonio de Murcia | Principal Investigator |
| Ana A Ramirez-Boscá, MD | Universidad Católica San Antonio de Murcia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Dermatológico Estético de Alicante | Alicante | Alicante | 03014 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25760018 | Background | Ramirez-Bosca A, Navarro-Lopez V, Martinez-Andres A, Such J, Frances R, Horga de la Parte J, Asin-Llorca M. Identification of Bacterial DNA in the Peripheral Blood of Patients With Active Psoriasis. JAMA Dermatol. 2015 Jun;151(6):670-1. doi: 10.1001/jamadermatol.2014.5585. No abstract available. | |
| 18284263 | Background |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Placebo | Dietary Supplement | one capsule per day, containing the placebo, along with the patient's customary psoriasis treatment (excluding systemic treatments) |
|
| 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 |
| Betsi GI, Papadavid E, Falagas ME. Probiotics for the treatment or prevention of atopic dermatitis: a review of the evidence from randomized controlled trials. Am J Clin Dermatol. 2008;9(2):93-103. doi: 10.2165/00128071-200809020-00002. |
| D019602 |
| Food and Beverages |