First Complementary Foods and the Infant Gastrointestinal Microbiota

University of Delaware

Status: Completed

Conditions: Healthy Participants; Infants; Gastrointestinal Microbiota

Treatments: Other: Infant fruit; Other: Infant meat; Other: Infant grain; Other: Infant vegetable

Study type: Interventional

Funder types: Other

Identifiers

NCT05492253

1889964-1

Details and patient eligibility

About

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

Full description

The introduction of solid foods plays a role in shaping the microbial communities of the gastrointestinal microbiota. This randomized, controlled, single-blinded trial will evaluate the effect of four infant foods (oatmeal cereal, carrot puree, prune puree, beef and gravy puree) on the gastrointestinal microbiota of exclusively human milk fed infants that have not previously consumed solid foods and who are developmentally ready for the introduction of solid foods.

Enrollment: 43 patients

Sex: All

Ages: 5 to 7 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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43 participants in 4 patient groups

Infant cereal

Active Comparator group

Description:

Oatmeal cereal

Treatment:

Other: Infant grain

Infant fruit

Experimental group

Description:

Pureed prunes

Treatment:

Other: Infant fruit

Infant vegetable

Experimental group

Description:

Pureed carrots

Treatment:

Other: Infant vegetable

Infant meat

Experimental group

Description:

Pureed beef

Treatment:

Other: Infant meat