NCT02576197

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Biopolis S.L. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	one capsule per day, containing the probiotic 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)

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2015-10-15
• Last updated: 2016-10-18

Locations

1 site across 1 country: Spain