First Complementary Foods and the Infant Gastrointestinal Microbiota

Healthy Participants Clinical Trial

Official title:

Effect of First Complementary Foods on the Infant Gastrointestinal Microbiota: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05492253
• Other study ID #: 1889964-1
• Status: Completed
• Phase: N/A
• Start date: January 30, 2023
• Est. completion date: March 12, 2024

Study information

• Verified date: May 2024
• Source: University of Delaware
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: March 12, 2024
• Est. primary completion date: March 12, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Months to 7 Months

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants
• Infants

Intervention

Other:
• Infant fruit
Infants will be fed prune puree
• Infant vegetable
Infants will be fed carrot puree
• Infant meat
Infants will be fed beef puree
• Infant grain
Infants will be fed oatmeal cereal

Locations

Country	Name	City	State
United States	University of Delaware	Newark	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
University of Delaware	American Society for Nutrition Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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