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

NCT06809465 | Completed DMC

• 1 other identifier: Ref. 6205/Sapienza University
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Probiotic Bifidobacterium bifidum PRL2010 (Bactopral®)

EXPERIMENTAL

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®

Placebo

PLACEBO COMPARATOR

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

Interventions

Bactopral® DIETARY_SUPPLEMENT

Oral Probiotic Bifidobacterium bifidum PRL2010 supplement

Probiotic Bifidobacterium bifidum PRL2010 (Bactopral®)

Plcebo OTHER

Oral placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: This study is limited to pregnant women as it investigates the effect of Bifidobacterium bifidum PRL2010 supplementation during pregnancy on the prevention of atopic dermatitis in their infants.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liaquat University of Medical & Health Sciences: lead
• Università degli Studi dell'Insubria: collaborator

Study Sites (1)

Sapienza University of Rome, Department of Maternal Infantile and Urological Sciences, Division of Pediatric Allergology and Immunology

Roma, 00161, Italy

Location

MeSH Terms

Conditions

Dermatitis, Atopic

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, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Biochemistry and Experimental medicine

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 5, 2025
• Study Start: September 1, 2022
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 5, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)