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

NCT02576197 | Completed

• 1 other identifier: PSO/PRO 2
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

mild to moderate; probiotic

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (5)

• Average time to reach the clinical remission

  twelve weeks

• Differences among any of the inflammation markers

  twelve weeks

• number of patients that remains in analytical remission

  twelve weeks

• Number of patients with mild, moderate or severe adverse events

  twelve weeks

• Number of patients with an improvement in the PGA score

  Twelve weeks

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

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

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

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

Probiotic

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biopolis S.L.: lead
• Korott, S.L.: collaborator

Study Sites (1)

Centro Dermatológico Estético de Alicante

Alicante, Alicante, 03014, Spain

Location

Related Publications (2)

• 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.

  PMID: 25760018 BACKGROUND

• 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.

  PMID: 18284263 BACKGROUND

MeSH Terms

Conditions

Psoriasis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Vicente Navarro-López, MD

  Universidad Católica San Antonio de Murcia

  PRINCIPAL INVESTIGATOR

• Ana A Ramirez-Boscá, MD

  Universidad Católica San Antonio de Murcia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2015
• First Posted: October 15, 2015
• Study Start: May 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 18, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)