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

Primary Purpose

Psoriasis

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Probiotic

Placebo

About this trial

This is an interventional supportive care trial for Psoriasis focused on measuring mild to moderate, probiotic

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Centro Dermatológico Estético de Alicante

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Probiotic

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

Differences among any of the inflammation markers

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)

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.

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

Full Information

NCT ID

NCT02576197

First Posted

October 13, 2015

Last Updated

October 17, 2016

Sponsor

Biopolis S.L.

Collaborators

Korott, S.L.

1. Study Identification

Unique Protocol Identification Number

NCT02576197

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

May 2015 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biopolis S.L.

Collaborators

Korott, S.L.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

Keywords

mild to moderate, probiotic

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

98 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Probiotic

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Probiotic

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

twelve weeks

Title

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

Description

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

Time Frame

twelve weeks

Secondary Outcome Measure Information:

Title

Average time to reach the clinical remission

Description

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

Time Frame

twelve weeks

Title

Differences among any of the inflammation markers

Time Frame

twelve weeks

Title

number of patients that remains in analytical remission

Description

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

Time Frame

twelve weeks

Title

Number of patients with mild, moderate or severe adverse events

Description

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

Time Frame

twelve weeks

Title

Number of patients with an improvement in the PGA score

Description

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

Time Frame

Twelve weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vicente Navarro-López, MD

Organizational Affiliation

Universidad Católica San Antonio de Murcia

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ana A Ramirez-Boscá, MD

Organizational Affiliation

Universidad Católica San Antonio de Murcia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centro Dermatológico Estético de Alicante

City

Alicante

ZIP/Postal Code

03014

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25760018

Citation

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.

Results Reference

background

PubMed Identifier

18284263

Citation

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.

Results Reference

background

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

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