Allergic diseases
Conditions
Interventions
Test Group A:Unhydrolyzed mixed protein food sauce
Test Group B:Lightly hydrolyzed mixed protein food sauce
Control Group C:Lean pork sauce
Sponsors
Nanjing Medical University
Eligibility
Sex/Gender
Female
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Gestational age between 20 to 28 weeks; 2. Natural conception, singleton pregnancy; 3. Maternal age between 20 to 45 years; 4. Normal pre-pregnancy body mass index or weight gain within the normal range during pregnancy; 5. Mother has the intention to breastfeed exclusively and is willing to breastfeed until the infant is 6 months old; 6. The infant (yet to be born) has a family history of allergic diseases, meaning that one of the parents or siblings has been diagnosed with an allergic disease by a physician, such as eczema, urticaria, asthma, rhinitis, food or drug allergies; 7. Willing to cooperate with the study, agree to full follow-up, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Maternal diseases that may jeopardize intrauterine growth; 2. Maternal gestational diabetes or severe metabolic diseases, chronic diseases; 3. Use of immunosuppressive drugs, antihistamines, and glucocorticoid therapy, gastroesophageal reflux; 4. Congenital malformations in infants; severe organ diseases; immune system diseases, hematological diseases, rickets, neurological diseases, severe infections, malignant tumor diseases; 5. Infants who cannot be fed normally or are completely artificially fed; 6. Preterm infants under 36 weeks, low birth weight infants, and macrosomic infants; 7. Participating in other clinical trials; 8. The researcher cannot determine whether the parents have the willingness or ability to follow the protocol requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of atopic dermatitis;Severity of atopic dermatitis;Incidence of urticaria;The incidence of gastrointestinal allergy symptoms;The incidence of respiratory allergy symptoms;Maternal sleep quality;Maternal physical activity status;Maternal psychological situation;Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum immune indicators (total IgE, allergen-specific IgE);Gut microbiota;Short-chain fatty acid;Physical development;Dietary status;Infant quality of life;Infant feeding status; | — |
Countries
China
Contacts
Public ContactZhixu Wang
Department of Maternal, Child and Adolescent Health, School of Public Health, Nanjing Medical University
Outcome results
None listed