Clinical trial NCT02576197: Intervention Study to Evaluate a Probiotic in Mild to Moderate Psoriasis Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Keywords: mild to moderate
probiotic
Lead sponsor: Biopolis S.L.
Sponsor class: INDUSTRY
Collaborators: name: Korott, S.L.
First posted: 2015-10-15
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients with a PASI score reduction higher than 75%
timeFrame: twelve weeks
measure: Time to reach a reduction in the PASI score higher than 75%
timeFrame: twelve weeks
Secondary outcomes:
measure: Average time to reach the clinical remission
timeFrame: twelve weeks
measure: Differences among any of the inflammation markers
timeFrame: twelve weeks
measure: number of patients that remains in analytical remission
timeFrame: twelve weeks
measure: Number of patients with mild, moderate or severe adverse events
timeFrame: twelve weeks
measure: Number of patients with an improvement in the PGA score
timeFrame: Twelve weeks
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Centro Dermatológico Estético de Alicante
Study officials:
affiliation: Universidad Católica San Antonio de Murcia
name: Vicente Navarro-López, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Católica San Antonio de Murcia
name: Ana A Ramirez-Boscá, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.