Clinical Trial to Evaluate Effectiveness of a Probiotic Preparation Administered to Patients With Alopecia Areata

NCT05599607 | Completed

• 1 other identifier: ALO.PRO
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alopecia Areata

Keywords

Probiotics

Outcome Measures

Primary Outcomes (3)

• Changes from baseline in signs of AA activity visualized by capillary trichoscopy at 16 and 24 weeks

  The signs of AA activity assessed in trichoscopy were: * Black dots (cadaveric hairs). Pigmented broken or fractured hairs at the level of the scalp * Broken or exclamation mark hairs (peladic hairs). Fractured hairs with the distal end frayed and thicker. * Broken hairs * Tapered hairs (coudability hairs). Hairs of normal length, but with a narrower proximal shaft (indicating activity at the base of the hair). * Pseudomonilethrix

  24 weeks

• Changes from baseline in signs of AA inactivity visualized by capillary trichoscopy at 16 and 24 weeks

  The signs of AA inactivity assessed in trichoscopy were: * Yellow dots * Fluffy hairs * Empty follicular orifices

  24 weeks

• Changes from baseline in signs of capillary repopulation visualized by capillary trichoscopy at 16 and 24 weeks

  The signs of capillary repopulation assessed in trichoscopy were: * Straight hairs in regrowth * Pigtail hairs * Fluffy hairs

  24 weeks

Secondary Outcomes (18)

• Changes from baseline in AA plaques number at 16 and 24 weeks

  24 weeks

• Changes from baseline in AA category/type at 16 and 24 weeks

  24 weeks

• Changes from baseline in SALT scale at 16 and 24 weeks

  24 weeks

• Changes from baseline in haemoglobin values at 24 weeks

  24 weeks

• Changes from baseline in leukocytes values at 24 weeks

  24 weeks

Other Outcomes (1)

• Adverse events at 4,8,12,16 and 24 weeks

  24 weeks

Study Arms (2)

Probiotic group

EXPERIMENTAL

Probiotic in capsule format administered orally. This probiotic product contains a mixture of strains of lactobacillus and bifidobacteria, called BTHS21, at concentrations equal to or greater than 1x109 cfu/dose.

Dietary Supplement: Probiotic mixture

Placebo group

PLACEBO COMPARATOR

Maltodextrin, masked in an identical and indistinguishable format to that of the probiotic

Dietary Supplement: Placebo

Interventions

Probiotic mixture DIETARY_SUPPLEMENT

Mixture of strains of lactobacillus and bifidobacteria

Probiotic group

Placebo DIETARY_SUPPLEMENT

Maltodextrin

Placebo group

Eligibility Criteria

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

You may qualify if:

• AA diagnosis by clinical criteria.
• Show at least 2 signs of AA activity, visualized by trichoscopy
• Signature of informed consent by the patient, in accordance with the legislation on clinical trials.

You may not qualify if:

• Allergies or contraindication to take any of the components of the product under study.
• Topical or systemic use of antifungals and antibiotics in the previous 2 weeks.
• Consumption of probiotics in the previous 2 months. - Participation in clinical studies in the previous 2 months.
• Pregnancy and/or lactation.

Sponsors & Collaborators

• Bioithas SL: lead
• Bionou Research, S.L.: collaborator

Study Sites (1)

Centro Dermatológico Estético

Alicante, 03014, Spain

Location

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

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

Model Details: Randomized, double-blind, with parallel-groups, and placebo-controlled

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: October 31, 2022
• Study Start: March 8, 2021
• Primary Completion: October 8, 2021
• Study Completion: December 30, 2021
• Last Updated: October 31, 2022

Record last verified: 2022-10

Locations

ES (1)