Clinical Trial to Evaluate the Effect of a Probiotic Mixture in the Treatment of Atopic Dermatitis in Children

NCT05443490 | Terminated

• 1 other identifier: ATOP_PRO.3
• Study Type: interventional
• Target: 4
• Locations: 3 countries
• Sites: 3

Brief Summary

A prospective case-control multicentric pilot study of 12 weeks duration to evaluate the effect of a probiotic mixture in the treatment of atopic dermatitis in children from 0 to 3 years old, by measuring the severity of the condition using the SCORAD index, as well as the Clinical Global Impression rating scale, the potential decrease in the use of corticosteroids and antihistamines, and the safety of the treatment under study by the number of adverse events related to the product under study.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the SCORAD index at 4,8 and 12 weeks

  SCORAD index measures the severity of the disease, wich takes into account the extent and intensity of five types of lesions (erythema, edema/papule, exudate/scab, excoriation and lichenification) as well as subjective symptoms (pruritus and loss of sleep). Subscales: Eczema Spread (A): 0 - 20 Eczema Intensity (B): 0 - 63 Subjective Symptoms (C): 0 - 20 Total = (A/5) + (Bx7/2) + C Total: 0 - 103 (Higher values represent a worse outcome)

  12 week

Secondary Outcomes (5)

• Number of days that each patient requires the administration of topical corticosteroids at 4, 8 and 12 weeks

  12 week

• Number of days that each patient requires the administration of topical corticosteroids in disease flares at 4, 8 and 12 weeks

  12 week

• Change from baseline in the CGI score at 4,8 and 12 weeks

  12 week

• Number of days that each patient requires the administration of antihistamines at 4, 8 and 12 weeks

  12 week

• Adherence to the treatment at 4, 8 and 12 weeks

  12 week

Other Outcomes (1)

• Number of adverse events from baseline at weeks 4, 8 and 12

  12 week

Study Arms (2)

Probiotic group

EXPERIMENTAL

Probiotic mixture

Dietary Supplement: Probiotic mixture with three bacterial strains with maltodextrin as a carrier.

Placebo group

PLACEBO COMPARATOR

Maltodextrine

Other: Placebo comparator with maltodextrin as a carrier.

Interventions

Probiotic mixture with three bacterial strains with maltodextrin as a carrier. DIETARY_SUPPLEMENT

Sachets containing a probiotic mixture at concentrations equal to or greater than 1x10\^9 colony forming unit (CFU) per dose, with maltodextrin as excipient.

Probiotic group

Placebo comparator with maltodextrin as a carrier. OTHER

Sachets containing maltodextrin

Placebo group

Eligibility Criteria

• Age: 6 Months - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Signature of informed consent from the parent / legal guardian of the patient.
• Patients with mild-moderate atopic dermatitis (SCORAD \>20).
• Age between 6 months and 3 years old, both inclusive (36 months).
• Patients using topical corticosteroids.
• Diagnosis of atopic dermatitis.

You may not qualify if:

• In treatment with phototherapy for atopic dermatitis in the previous 2 months
• In treatment with systemic corticosteroids in the previous month.
• In treatment with immunosuppressants or cytostatics in the previous 2 months.
• Those who have received probiotic treatment in the previous month.
• Those who have been treated with systemic antibiotics in the previous two weeks.
• Patients with axillary or oral temperature \> 37.5ºC; or rectal or otic temperature \> 38ºC.
• Patients with severe allergic diseases.
• Patients with pathologies related to immunodeficiency or cancer processes.
• Patients with other dermatological pathologies that may make it difficult to assess atopic dermatitis or require the continued use of topical corticosteroids.
• Patients in whom any of the products under study is contraindicated as established in their technical specifications.
• Patients who have participated in drug research studies in the previous 3 months

Sponsors & Collaborators

• Bionou Research, S.L.: lead
• Biopolis S.L.: collaborator

Study Sites (3)

Hospital del niño Dr. Ovidio Aliaga Uria y Hospital Arco Iris

La Paz, La Paz Department, 10097, Bolivia

Location

Centro de Especialidades Dermatológicas Ac S.A (Dermaláser)

San José, Provincia de San José, Sabana Oeste, T. Médica 20/20, Costa Rica

Location

Hospital Universitario del Vinalopó

Elche, Alicante, 03293, Spain

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

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

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 5, 2022
• Study Start: February 8, 2023
• Primary Completion: June 22, 2023
• Study Completion: June 22, 2023
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1); ES (1); BO (1)