Trial | NCT02576197  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    98
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.
Study Started
May 31
2015
Primary Completion
Sep 30
2016
Study Completion
Sep 30
2016
Last Update
Oct 18
2016
Estimate

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)

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)

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.
No Results Posted