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

Not Applicable

Completed

• Conditions: Psoriasis
• Interventions: Dietary Supplement: Probiotic; Dietary Supplement: Placebo

• Registration Number: NCT02576197
• Lead Sponsor: Biopolis S.L.

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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-10-13
• Study First Submitted QC: 2015-10-14
• Study First Posted: 2015-10-15
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-17
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Probiotic	one capsule per day, containing the probiotic along with the patient's customary psoriasis treatment (excluding systemic treatments)
Placebo	Placebo	one capsule per day, containing the placebo, along with the patient's customary psoriasis treatment (excluding systemic treatments)

Primary Outcome Measures

Name	Time	Method
Time to reach a reduction in the PASI score higher than 75%	twelve weeks	time to reach a reduction in the PASI score higher than 75% in from the basal value
Number of patients with a PASI score reduction higher than 75%	twelve weeks	Number of patients with a PASI score reduction higher than 75% from the basal value

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centro Dermatológico Estético de Alicante; 🇪🇸 Alicante, Spain