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

NCT ID: NCT02576197

Last Updated: 2016-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-09-30

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.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Probiotic

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

Group Type: ACTIVE_COMPARATOR

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Probiotic

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korott, S.L.

INDUSTRY

Sponsor Role: collaborator

Biopolis S.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vicente Navarro-López, MD

Role: PRINCIPAL_INVESTIGATOR

Universidad Católica San Antonio de Murcia

Ana A Ramirez-Boscá, MD

Role: PRINCIPAL_INVESTIGATOR

Universidad Católica San Antonio de Murcia

Locations

Centro Dermatológico Estético de Alicante

Alicante, Alicante, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 25760018 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18284263 (View on PubMed)

Other Identifiers

PSO/PRO 2

Identifier Type: -

Identifier Source: org_study_id