First Complementary Foods and the Infant Gastrointestinal Microbiota

NCT05492253 | Completed

• 1 other identifier: 1889964-1
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Participants; Infants; Gastrointestinal Microbiota

Keywords

Healthy term infant; Complementary diet; Gastrointestinal microbiota

Outcome Measures

Primary Outcomes (1)

• Change in gastrointestinal microbiota

  Composition of the gastrointestinal microbiota (family, genus, and species levels via shotgun metagenomic sequencing) before and after the introduction of solid food

  Day 0, 3, 7, 10, 14

Study Arms (4)

Infant cereal

ACTIVE COMPARATOR

Oatmeal cereal

Other: Infant grain

Infant fruit

EXPERIMENTAL

Pureed prunes

Other: Infant fruit

Infant vegetable

EXPERIMENTAL

Pureed carrots

Other: Infant vegetable

Infant meat

EXPERIMENTAL

Pureed beef

Other: Infant meat

Interventions

Infant fruit OTHER

Infants will be fed prune puree

Infant fruit

Infant vegetable OTHER

Infants will be fed carrot puree

Infant vegetable

Infant meat OTHER

Infants will be fed beef puree

Infant meat

Infant grain OTHER

Infants will be fed oatmeal cereal

Infant cereal

Eligibility Criteria

• Age: 5 Months - 7 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• University of Delaware: lead
• American Society for Nutrition Foundation: collaborator

Study Sites (1)

University of Delaware

Newark, Delaware, 19713, United States

Location

Study Officials

• Jillian Trabulsi, PhD, RD

  University of Delaware

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: August 8, 2022
• Study Start: January 30, 2023
• Primary Completion: March 12, 2024
• Study Completion: March 12, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)