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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05492253
Other study ID # 1889964-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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