First Complementary Foods and the Infant Gastrointestinal Microbiota

Completed · Not applicable

Conditions studied: Healthy Participants, Infants, Gastrointestinal Microbiota

In brief

This study evaluates the effect of different complementary foods on the gastrointestinal microbiota of exclusively human milk fed infants.

Key facts

Study ID

NCT05492253

Run by

University of Delaware

People needed

43

Starts

2023-01-30

Expected to finish

2024-03-12

Last updated by the study team

2024-05-17

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Infant was born vaginally
• Infant was born full term
• Infant has no significant gastrointestinal medical issues/diagnoses (e.g., gastroesophageal reflux, malabsorption syndromes, Celiac disease, Crohn's disease, or physician diagnosed or suspected food allergies)
• Infant is at least 5 months old, but not 8 or more months old
• Infant consumes an exclusively human milk liquid diet only
• Infant has not yet begun consuming solid foods
• Infant is developmentally ready to begin consuming solid foods (i.e., has good head and neck control, can sit upright when supported, and has at least doubled their birth weight)
• Infant has not had antibiotics within the past month
• Infant's nursing mother has not had antibiotics within the past month
• Parent/legal guardian is at least 18 years old

You may not qualify if…

• Infant is not developmentally ready to begin solid foods
• Infant has a family history of food allergy

Where it is running

• University of Delaware — Newark, Delaware, United States

Full record on ClinicalTrials.gov

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