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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Incidence of Atopic Dermatitis in Infants
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Incidence of Atopic Dermatitis in Infants
时间窗: 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.
次要结局
未报告次要终点
研究者
Dr. Amjad Khan
Professor of Clinical Biochemistry and Experimental medicine
Liaquat University of Medical & Health Sciences