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Completed

NCT Number: NCT02576197

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Dermatológico Estético de Alicante

Alicante, 03014, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic

Dietary Supplement

one capsule per day, containing the probiotic along with the patient's customary psoriasis treatment (excluding systemic treatments)

Placebo

Dietary Supplement

one capsule per day, containing the placebo, along with the patient's customary psoriasis treatment (excluding systemic treatments)

Primary outcomes

  1. Number of patients with a PASI score reduction higher than 75%

    Time frame: twelve weeks

    Number of patients with a PASI score reduction higher than 75% from the basal value

  2. Time to reach a reduction in the PASI score higher than 75%

    Time frame: twelve weeks

    time to reach a reduction in the PASI score higher than 75% in from the basal value

Secondary outcomes

  1. Average time to reach the clinical remission

    Time frame: twelve weeks

    Average time to reach the clinical remission, with no activity (PASI score lower than 6) from the treatment beginning

  2. Differences among any of the inflammation markers

    Time frame: twelve weeks

  3. number of patients that remains in analytical remission

    Time frame: twelve weeks

    number of patients that remains in analytical remission (that is, that maintain said inflammation markers in normal values)

  4. Number of patients with mild, moderate or severe adverse events

    Time frame: twelve weeks

    Number of patients with mild, moderate or severe adverse events attributable to regular treatment to psoriasis or to probiotic.

  5. Number of patients with an improvement in the PGA score

    Time frame: Twelve weeks

    Number of patients with an improvement in the PGA score at the end of the study with regard of basal values

Sponsors and collaborators

Lead sponsor

Biopolis S.L.

Industry

Collaborators

  • Korott, S.L.

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 15, 2015
Registry last updated
Oct 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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