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

Randomized, Double Blind, Placebo-controlled Clinical Trial to Evaluate the Effect of a Probiotic Mixture in the Treatment of Atopic Dermatitis in Children From 0 to 3 Years Old

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.

Study Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Dietary supplement: Probiotic mixture with three bacterial strains with maltodextrin as a carrier.; Other: Placebo comparator with maltodextrin as a carrier.

Detailed Description

Atopic dermatitis is a chronic inflammatory disease of the skin, which first symptoms usually develop during childhood, and approximately 50% of cases are diagnosed in the first year of life.

The diagnosis of atopic dermatitis is clinical, because there are no specific microscopic or laboratory changes. One aspect of establishing the diagnosis is the measurement of the severity of the process in these patients. In this regard, one of the best validated methods, more contrasted, more accepted, used and most recommended is the composite scale called index SCORAD (Scoring Atopic Dermatitis). This index consists of a scoring system that takes into account the extent and intensity of five fundamental types of lesions (erythema, edema / papule, exudate / scab, excoriation and lichenification), as well as symptoms (pruritus and loss of sleep) they provoke.

The use of probiotics in the treatment of Atopic Dermatitis has been studied in recent years in a limited number of pilot studies with variable results depending on the probiotic used and the age of the patients included in the study. Recent studies, including a meta-analysis of previous publications, demonstrate a beneficial effect of the use of probiotics in certain circumstances related to age, the type of probiotic used, the dose and combination of probiotics.

In our previous study, the efficacy and safety of the probiotic were demonstrated. The objective of this study is to confirm whether the treatment improves the evolution of the SCORAD index (difference between the values of the first visit and the final one) in children under 4 years of age, comparing the mean of this value in the probiotic group with the control group. For this, a similar methodology will be applied and the same mixture of strains will be used as in the previous study.

Generally speaking, the goals of treatment of atopic dermatitis are to prevent itching, remove exudate, cure the infection, remove the inflammatory lesion, and prevent relapses. To eliminate itching, and the scratching caused by it, recently developed antihistamines are usually used from the acute phase, since the classic ones can present adverse effects on the central nervous system (CNS) that interfere with daily activities. In other hand, in the flare fase or acute exacerbation of atopic dermatitis, topical corticosteroids are used daily, and during the remission phase, weekly regimens can be used.

The main and secondary objectives of this study, aimed to asses the effect of a probiotic mixture in atopic dermatitis are :

PRIMARY OBJECTIVE

Determine if the product under study has an effect on the evolution and treatment of atopic dermatitis, defined as a decrease in the SCORAD index score.

SECONDARY OBJECTIVES

Determine whether the product under study causes a decrease in the use of topical corticosteroids.

Study if the product under study has an effect on the evolution of the Clinical Global Impression (CGI).

Check if the treatment under study reduces the need to use antihistamines. Evaluate the rate of compliance with the treatment during the development of the study.

Study the safety of the treatment under study, defined as the number of adverse events related to the product under study, referred by the patient that occur during the development of the study.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vicente Navarro López, CEO; Phone Number: +34 695845742; Email: vicente.navarro@bioithas.com
• Study Contact Backup: Name: Laura Navarro Moratalla; Phone Number: +34 623022586; Email: laura.navarro@bioithas.com

Study Locations

• Spain
  • Murcia, Spain, 30570
    • Recruiting
    • Centro de Salud Beniaján
    • Contact: Fuensanta Costa Guirao, MD
  • Murcia, Spain
    • Recruiting
    • Centro Médico Privado
    • Contact: Gregorio Vicente García, MD
  • Alicante
    • Elche, Alicante, Spain, 03293
      • Recruiting
      • Hospital Universitario del Vinalopó
      • Contact: Laura Murcia Clemente, MD
  • Murcia
    • Alcantarilla, Murcia, Spain, 30820
      • Recruiting
      • Centro de Salud Alcantarilla Casco
      • Contact: Carlos Morte Gamboa, MD
    • Alcantarilla, Murcia, Spain, 30820
      • Recruiting
      • Centro de Salud Alcantarilla/Sangonera
      • Contact: Begoña Pelegrín López, MD
    • Torre Pacheco, Murcia, Spain, 30700
      • Recruiting
      • Centro de Salud Torre Pacheco Este
      • Contact: Laura Úbeda Cuenca, MD
    • Torre Pacheco, Murcia, Spain, 30700
      • Recruiting
      • Centro de Salud Torre Pacheco Oeste
      • Contact: Esther Inglés Torres, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 3 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Signature of informed consent from the parent / legal guardian of the patient.
• Patients with mild-moderate atopic dermatitis (SCORAD 20-40).
• Age between 6 months and 3 years old, both inclusive.
• Patients using topical corticosteroids.
• Diagnosis of atopic dermatitis.

Exclusion Criteria:

• In treatment with phototherapy for atopic dermatitis in the previous 2 months
• In treatment with systemic corticosteroids in the previous 2 months.
• In treatment with immunosuppressants or cytostatics in the previous 2 months.
• Those who have received probiotic treatment in the previous two months.
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic group; Probiotic mixture	Dietary supplement: Probiotic mixture with three bacterial strains with maltodextrin as a carrier.; Sachets containing a probiotic mixture at concentrations equal to or greater than 1x10^9 colony forming unit (CFU) per dose, with maltodextrin as excipient.
Placebo Comparator: Placebo group; Maltodextrine	Other: Placebo comparator with maltodextrin as a carrier.; Sachets containing maltodextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Clinical Global Impression (CGI) measures the severity of the disease on a 6-point scale, based on the global assessment of the skin lesions. Total: 0 - 5 (Higher values represent a worse outcome)	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	Percentage of treatment intake days	12 week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events from baseline at weeks 4, 8 and 12	Adverse events referred by the patient's parents that occur during the development of the study	12 week

Collaborators and Investigators

• Sponsor: Bionou Research, S.L.
• Collaborators: Biopolis S.L.

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: ATOP_PRO.3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No