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

Liaquat University of Medical & Health Sciences

Status: Completed

Conditions: Atopic Dermatitis

Treatments: Dietary Supplement: Bactopral®; Other: Plcebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06809465

Ref. 6205/Sapienza University

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Probiotic Bifidobacterium bifidum PRL2010 (Bactopral®)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Bactopral®

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Plcebo