Clinical trial NCT06809465: Effect of Probiotic Bifidobacterium Bifidum PRL 2010 in the Prevention of Atopic Dermatitis in Children
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Lead sponsor: Liaquat University of Medical & Health Sciences
Sponsor class: OTHER
Collaborators: name: Università degli Studi dell'Insubria
First posted: 2025-02-05
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Atopic Dermatitis in Infants
timeFrame: 12 months from birth
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Sapienza University of Rome, Department of Maternal Infantile and Urological Sciences, Division of Pediatric Allergology and Immunology
Study officials:
References: