First Complementary Foods and the Infant Gastrointestinal Microbiota

May 15, 2024 updated by: Jill Trabulsi, University of Delaware

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19713
        • University of Delaware

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 7 months (Child)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Infant cereal
Oatmeal cereal
Other: Infant grain
Infants will be fed oatmeal cereal
Experimental: Infant fruit
Pureed prunes
Other: Infant fruit
Infants will be fed prune puree
Experimental: Infant vegetable
Pureed carrots
Other: Infant vegetable
Infants will be fed carrot puree
Experimental: Infant meat
Pureed beef
Other: Infant meat
Infants will be fed beef puree

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in gastrointestinal microbiota
Time Frame: 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
Day 0, 3, 7, 10, 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Delaware

Collaborators

American Society for Nutrition Foundation

Investigators

  • Principal Investigator: Jillian Trabulsi, PhD, RD, University of Delaware

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2023

Primary Completion (Actual)

March 12, 2024

Study Completion (Actual)

March 12, 2024

Study Registration Dates

First Submitted

July 26, 2022

First Submitted That Met QC Criteria

August 4, 2022

First Posted (Actual)

August 8, 2022

Study Record Updates

Last Update Posted (Actual)

May 17, 2024

Last Update Submitted That Met QC Criteria

May 15, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1889964-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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