Prevention of food allergy by administration of synbiotics

JRCT ID: jRCTs041220130

Registered date:27/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Food allergy
• Date of first enrollment: 30/01/2023
• Target sample size: 336
• Study type: Interventional
• Intervention(s): Pregnant women are administered one packet of synbiotic or placebo daily from week 34-35 of gestation to day 5 postpartum, and newborns are administered one packet of synbiotic or placebo daily the first 5 days of life.

Outcome(s)

• Primary Outcome: Rate of patients who developed food allergy with hens' egg or cow's milk or wheat at 12 months of age

Secondary Outcome

Molecular systematics analysis and alpha and beta diversity based on 16S rRNA genes in the stool of mothers at 30-34 weeks gestation and during postpartum hospitalization (1-5 days postpartum), and breast milk of mothers during postpartum hospitalization (1-5 days postpartum), and at 1 month postpartum.
Molecular systematics analysis and alpha and beta diversity based on 16S rRNA genes in the stool of infants at 3-5 days of age, 1 month, 4 months, and 12 months of age, and skin of infants at 3-5 days of age, and 1 month of age
Rate of patients with sensitization to egg white, milk, wheat, peanut, walnut, and cashew nut at 12 months of age
Specific IgE levels, blood short-chain fatty acid levels, IgA levels at stool, EASI score, and TEWL scores at 4 and 12 months of age
Results of oral food challenge and provoked allergic symptoms due to the consumption of egg, milk or wheat until the infants were 12 months old
Rate of infants with food allergy at 12 months of age after classifying by mode of delivery, antibiotic use, nutritional methods for children, and environmental factors
Rate of patients with food allergy at 12 months of age after stratification by skin condition and presence of atopic dermatitis
Impact of interventions on the development of food allergy by patient background factors (secondary analysis)
Rate of patients with severe infectious diseases requiring hospitalization from birth to 12 months of age
Rate of patients with food allergy and sensitization by the duration of administration of synbiotics to children
Rate of patients with atopic dermatitis, bronchial asthma, allergic rhinitis, and food allergy at 24 and 36 months of age

Key inclusion & exclusion criteria

• Age minimum: >=
• Age maximum: Not applicable
• Gender: Both

Include criteria

<Pregnant woman>
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.
<Infant>
3.Day 1 child born to a pregnant woman meeting 1.2 criteria above.

Exclude criteria

<Pregnant woman>
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
<Infant>
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

Related Information

• Primary Sponsor: Yanagida Noriyuki
• Source(s) of Monetary Support: Nnational Hospital Organization