First Complementary Foods and the Infant Gastrointestinal Microbiota

Not Applicable

Completed

• Conditions: Healthy Participants; Infants; Gastrointestinal Microbiota
• Interventions: Other: Infant grain; Other: Infant vegetable; Other: Infant meat; Other: Infant fruit

• Registration Number: NCT05492253
• Lead Sponsor: University of Delaware

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2022-07-26
• Study First Submitted QC: 2022-08-04
• Study First Posted: 2022-08-08
• Study Start: 2023-01-30
• Primary Completion: 2024-03-12
• Study Completion: 2024-03-12
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infant cereal	Infant grain	Oatmeal cereal
Infant vegetable	Infant vegetable	Pureed carrots
Infant meat	Infant meat	Pureed beef
Infant fruit	Infant fruit	Pureed prunes

Primary Outcome Measures

Name	Time	Method
Change in gastrointestinal microbiota	Day 0, 3, 7, 10, 14	Composition of the gastrointestinal microbiota (family, genus, and species levels via shotgun metagenomic sequencing) before and after the introduction of solid food

Trial Locations

Locations (1)

University of Delaware; 🇺🇸 Newark, Delaware, United States