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

NCT ID: NCT06809465

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-12-31

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Probiotic Bifidobacterium bifidum PRL2010 (Bactopral®)

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.

Group Type: EXPERIMENTAL

Bactopral®

Intervention Type: DIETARY_SUPPLEMENT

Oral Probiotic Bifidobacterium bifidum PRL2010 supplement

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Plcebo

Intervention Type: OTHER

Oral placebo

Interventions

Bactopral®

Oral Probiotic Bifidobacterium bifidum PRL2010 supplement

Intervention Type: DIETARY_SUPPLEMENT

Plcebo

Oral placebo

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Università degli Studi dell'Insubria

OTHER

Sponsor Role: collaborator

Liaquat University of Medical & Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Dr. Amjad Khan

Professor of Clinical Biochemistry and Experimental medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Roma, , Italy

Countries

Italy

Other Identifiers

Ref. 6205/Sapienza University

Identifier Type: -

Identifier Source: org_study_id