Clinical Trial to Evaluate Effectiveness of a Probiotic Preparation Administered to Patients With Alopecia Areata
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional

Summary: 
      This study is part of a broader project that proposes the characterization of what we call
      the "Entire-Systemic Axis". It aims to study whether the bacteria present in the human skin
      microbiota and in the human intestinal microbiota can play a role in the pathophysiology of
      Alopecia Areata (AA), a fact that has not been studied to date. Based on the supposed
      relationship between the human microbiota and AA, we have formulated the hypothesis that the
      dietary supplementation of specific probiotic strains, with functional capacities on
      mucocutaneous tissue and its adnexa, could benefit patients with AA, acting on the patients'
      microbiome profile.
    

Detailed description: 
      This clinical study was designed to be a randomized, double-blind, with parallel-groups, and
      placebo-controlled with a duration of 24 weeks duration.

      The 24 weeks of intervention were structured in 6 face-to-face visits in consultation: visit
      1 or initial (week 0), visit 2 (week 4), visit 3 (week 8), visit 4 (week 12), visit 5 (week
      16) and visit 6 or end of study (week 24).

      Visit 1 or initial (Week 0)

      To recruit patients, all those voluntaries who attended the participating centre showing
      interest in the study with AA diagnosis meeting the criteria indicated in the study protocol
      were thoroughly informed of the study as well as of the implications of their participation.

      Once the informed consent was signed a physician trained for the study conducted the initial
      interview The researcher proceeded to assign the patient a participant number in the study.
      According to a previously prepared randomization list, the patient was assigned the treatment
      received during the study by contacting the randomization centre Likewise, in this initial
      visit, the clinical history and capillary measurements were made: trichoscopy, plaques
      counting and photographs. In addition, the patient underwent a blood draw, and a skin sample
      from the area of plaques as well as sample of faeces was collected.

      Finally, following the therapeutic protocol, a local infiltration of corticosteroids was
      performed and data from the DLQI subjective scale was collected.

      The patient was given enough treatment to cover the period until the next scheduled visit
      according to its assigned code

      Intermediate visits 2, 3 and 4 (Weeks 4, 8 and 12 respectively)

      In addition to assessing the symptoms of the disease, the infiltration of topical
      corticosteroids and taking photographs was performed during these visits. The researcher
      recorded the adverse events reported by the patient (including the start date and in case
      those adverse events had already been resolved at the time of the visit the end date) as well
      as the accounting of the remaining product to evaluate treatment compliance in the Case
      Report Form (CRF).

      The patient was given enough treatment to cover the period until the next scheduled visit
      according to its assigned code.

      Intermediate Visit 5 (Week 16)

      Besides performing the same procedures as in previous intermediate visits 2, 3 and 4, in this
      visit capillary measurements were added.

      The patient was given enough treatment to cover the period until the next scheduled visit
      according to its assigned code

      Visit 6 or final (Week 24)

      During this final visit, the same procedures as in visit 1 were conducted, including
      capillary measurements and sample collection.

      Possible adverse events were recorded, specifying the start and end dates, and the treatment
      received, if any. In addition, patient's leftover study product was collected
    

Intervention name(s): Probiotic mixture; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Mixture of strains of lactobacillus and bifidobacteria; Maltodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, with parallel-groups, and placebo-controlled
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Probiotics