Effect of Probiotic Bifidobacterium Bifidum PRL 2010 in the Prevention of Atopic Dermatitis in Children

Effect of Supplementation of Probiotic Bifidobacterium Bifidum PRL2010) in Pregnancy for the Prevention of Atopic Dermatitis in Children: A Randomised, Double-blind, Placebo-controlled Trial

This study evaluates the effect of supplementation with Bifidobacterium bifidum PRL2010 during pregnancy in preventing atopic dermatitis in children. Pregnant women with a history of atopy or family history of allergies will be randomized to receive either the probiotic or a placebo. Outcomes include the incidence and severity of atopic dermatitis in infants up to 12 months of age.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Dietary supplement: Bactopral®; Other: Plcebo

Detailed Description

Atopic dermatitis (AD) is a growing public health concern due to its increasing prevalence and significant impact on quality of life. This randomized, double-blind, placebo-controlled pilot study investigates the efficacy of Bifidobacterium bifidum PRL2010 in preventing AD when administered during pregnancy. Women aged 18-45 with a history of atopy or family history of allergies will be recruited and randomized into two groups: one receiving the probiotic and the other receiving a placebo. The intervention will begin at the 36th week of pregnancy and continue postpartum during breastfeeding for two months. Infants will subsequently receive the same treatment from the 3rd to 6th month of life. Outcomes include the presence and severity of AD assessed using the SCORAD index and additional allergy tests at 3, 6, and 12 months of age. This pilot aims to assess feasibility, safety, and initial efficacy data for future larger-scale studies.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00161
    • Sapienza University of Rome, Department of Maternal Infantile and Urological Sciences, Division of Pediatric Allergology and Immunology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Pregnant women aged 18-45 years.
• Presence of allergic manifestations or a positive family history of allergies.
• Normal pregnancy without complications (e.g., no risk of eclampsia or gestational diabetes).
• Residing in Rome.
• Non-smoker and non-smoking partner.
• Absence of pets.
• Planning natural childbirth.
• Intention to breastfeed for at least 3 months.

Exclusion Criteria:

• Complications during pregnancy (e.g., preterm birth before 36 weeks).
• Infants with necrotizing enterocolitis or congenital, chronic, or metabolic diseases.
• Immunodeficiencies in mother or child.
• Failure to meet any inclusion criteria during the study period.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic Bifidobacterium bifidum PRL2010 (Bactopral®); Participants in this arm will receive probiotic Bifidobacterium bifidum PRL2010 (Bactopral®) supplement. Each Bactopral®s sachet contains 1 billion CFU/sachet of the Bifidobacterium bifidum PRL2010. Mothers will take one sachet daily starting at the 36th week of pregnancy and continuing until delivery. During the first two months postpartum, mothers will continue daily doses. Infants will then receive the same probiotic from the 3rd to 6th month of life. Probiotic powder will be mixed with breast milk and administered via teaspoon or syringe.	Dietary supplement: Bactopral®; Oral Probiotic Bifidobacterium bifidum PRL2010 supplement
Placebo Comparator: Placebo; Participants in this arm will receive a placebo identical in appearance, smell, and taste to the probiotic. The placebo contains bacteria-free maltodextrins. Administration will follow the same schedule as the probiotic arm.	Other: Plcebo; Oral placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Atopic Dermatitis in Infants	The presence of atopic dermatitis in infants will be evaluated using the SCORAD index at 3, 6, and 12 months of age.	12 months from birth

Collaborators and Investigators

• Sponsor: Liaquat University of Medical & Health Sciences
• Collaborators: Università degli Studi dell'Insubria

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: January 30, 2025
• First Submitted That Met QC Criteria: January 30, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 30, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis, Atopic; Dermatitis; Eczema
• Other Study ID Numbers: Ref. 6205/Sapienza University

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