NCT06809465

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Liaquat University of Medical & Health Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Bactopral®	Oral Probiotic Bifidobacterium bifidum PRL2010 supplement
OTHER	Plcebo	Oral placebo

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-10-31
• Completion: 2024-12-31
• First posted: 2025-02-05
• Last updated: 2025-02-05

Locations

1 site across 1 country: Italy