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

Psoriasis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02576197
• Other study ID #: PSO/PRO 2
• Status: Completed
• Phase: N/A
• First received: October 13, 2015
• Last updated: October 17, 2016
• Start date: May 2015
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: Biopolis S.L.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Psoriasis

Intervention

Dietary Supplement:
• Probiotic
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)

Locations

Country	Name	City	State
Spain	Centro Dermatológico Estético de Alicante	Alicante

Sponsors (2)

Lead Sponsor	Collaborator
Biopolis S.L.	Korott, S.L.

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. Review. — View Citation

Ramírez-Boscá A, Navarro-López V, Martínez-Andrés A, Such J, Francés R, Horga de la Parte J, Asín-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with a PASI score reduction higher than 75%	Number of patients with a PASI score reduction higher than 75% from the basal value	twelve weeks	No
Primary	Time to reach a reduction in the PASI score higher than 75%	time to reach a reduction in the PASI score higher than 75% in from the basal value	twelve weeks	No
Secondary	Average time to reach the clinical remission	Average time to reach the clinical remission, with no activity (PASI score lower than 6) from the treatment beginning	twelve weeks	No
Secondary	Differences among any of the inflammation markers		twelve weeks	No
Secondary	number of patients that remains in analytical remission	number of patients that remains in analytical remission (that is, that maintain said inflammation markers in normal values)	twelve weeks	No
Secondary	Number of patients with mild, moderate or severe adverse events	Number of patients with mild, moderate or severe adverse events attributable to regular treatment to psoriasis or to probiotic.	twelve weeks	Yes
Secondary	Number of patients with an improvement in the PGA score	Number of patients with an improvement in the PGA score at the end of the study with regard of basal values	Twelve weeks	No