Atopic Dermatitis
Conditions
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.
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.
Interventions
DIETARY_SUPPLEMENTBactopral®
Oral Probiotic Bifidobacterium bifidum PRL2010 supplement
OTHERPlcebo
Oral placebo
Sponsors
Università degli Studi dell'Insubria
Liaquat University of Medical & Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Atopic Dermatitis in Infants | 12 months from birth | The presence of atopic dermatitis in infants will be evaluated using the SCORAD index at 3, 6, and 12 months of age. |
Countries
Italy
Outcome results
None listed