Efficacy of perinatal synbiotics supplementation on primary prevention of the onset of food allergy in high-risk children: a multicenter, randomized, double-blind, placebo-controlled trial

Yanagida Noriyuki0 个研究点目标入组 336 人开始时间: 2023年1月27日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1.Pregnant women over 18 years of age, between 22 to 34 weeks of pregnancy
•2.The pregnant woman or her partner or a sibling has one or more of the following allergic diseases ;atopic dermatitis, bronchial asthma, food allergy, allergic rhinitis, allergic conjunctivitis.
•3.Day 1 child born to a pregnant woman meeting 1.2 criteria above.

•1. Having difficulty ingesting synbiotics due to an existing medical condition
•2. When a physician determines the patient has difficulty in participating in the study.
•3. Multiple pregnancies
•4. Having participated in this study at the time of previous pregnancy
•5. Underlying medical conditions that were identified prenatally or postnatally that would make it difficult to administer synbiotics (cardiac disease, neuromuscular disease, hematological disease, gastrointestinal disease, bone system disease/endocrine/metabolic disease, immunological/allergic disease, diseases of the skin, eye and appendages, congenital malformations, chromosomal abnormalities).
•6. Birth weight less than 2300g
•7. Preterm (less than 37 weeks of gestation) or Post term (42 weeks or more of gestation)
•8. Severe neonatal distress (Apgar score<4)
•9. Physician has determined that it is difficult to perform the study

发起方

Yanagida Noriyuki