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Prevention of food allergy by administration of synbiotics

Phase 3
Recruiting
Conditions
Food allergy
Registration Number
JPRN-jRCTs041220130
Lead Sponsor
Yanagida Noriyuki
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
336
Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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