Phase
Condition
Breast Feeding
Treatment
Not applicable: Observational study without any interventions.
Clinical Study ID
Ages > 18 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Mothers:
Generally healthy mothers with the intention to breastfeed.
Aged 18 years and above.
Written informed consent.
Infants:
Generally healthy term born (gestational age between 37 and 42 weeks).
Breastfed by their mothers, either exclusively or in combination with infant milkformula, at enrolment.
Chinese ethnicity of mother and father.
Exclusion
Exclusion Criteria:
Mothers:
Participation in any other studies involving investigational or marketed productsconcomitantly or two weeks prior to entry into the study.
Difficulty to follow up and/or locate (e.g. known transfer to other hospitals,residing outside the city where the study site is located, or planning to move outof the current city; incapability of mothers to comply with study protocol orinvestigator' s uncertainty about the willingness or ability of the mothers tounderstand and comply with the protocol requirements.
Illegal drug use.
Regular smoking and/ or consumption of alcoholic beverages as per investigator'sjudgement.
A BMI of <18.5 or ≥ 28 pre-pregnancy or during the first regular pregnancy checkaround or before 16 weeks of gestational age.
Acute infectious disease or neoplastic disease or any kind of weakening ordebilitating conditions (with history of positive, hepatitis C virus (HCV) or HIVserological test at any time during the pregnancy).
Presence of mastitis, fungal infections of the nipple or areola; reactivation ofherpes simplex (HSV) or varicella zoster infection in the mammary or thoracic regionat the time of enrolment.
Presence of chronic diseases such as endocrine, cardiovascular, renal, respiratoryor hepatic diseases.
Presence of psychosis and severe post-partum depression.
Presence of autoimmune disease such as systemic lupus erythematosus, systemicscleroderma, ulcerative colitis, Crohn's disease, celiac disease.
Women whose health condition, according to the investigator's judgement, couldinterfere with the study conduction and assessment.
Mothers who have given birth to twins or multiples or infant conceived with AssistedReproductive Technology (ART).
Infants:
Participation in any other studies involving investigational or marketed productsconcomitantly or two weeks prior to entry into the study.
At enrolment, any congenital abnormality, chromosomal disorder or severe diseasewhich could interfere with the study conduct and assessment.
Consumption of food other than breast milk or infant formula.
Fully formula fed at enrolment.
Study Design
Study Description
Connect with a study center
Nanjing Medical University Jiangning Campus
Nanjing, Jiangsu 211166
ChinaActive - Recruiting
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