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

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Dietary supplement: Probiotic; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain, 03014
    • Centro Dermatológico Estético de Alicante

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Probiotic; one capsule per day, containing the probiotic along with the patient's customary psoriasis treatment (excluding systemic treatments)	Dietary supplement: Probiotic; one capsule per day, containing the probiotic along with the patient's customary psoriasis treatment (excluding systemic treatments)
Placebo Comparator: Placebo; one capsule per day, containing the placebo, along with the patient's customary psoriasis treatment (excluding systemic treatments)	Dietary supplement: Placebo; one capsule per day, containing the placebo, along with the patient's customary psoriasis treatment (excluding systemic treatments)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Biopolis S.L.
• Collaborators: Korott, S.L.
• Investigators: Principal Investigator: Ana A Ramirez-Boscá, MD, Universidad Católica San Antonio de Murcia

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: October 13, 2015
• First Submitted That Met QC Criteria: October 14, 2015
• First Posted (Estimate): October 15, 2015

Study Record Updates

• Last Update Posted (Estimate): October 18, 2016
• Last Update Submitted That Met QC Criteria: October 17, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: probiotic; mild to moderate
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: PSO/PRO 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No