First Complementary Foods and the Infant Gastrointestinal Microbiota

University of Delaware (Other)
Overall Status
Not yet recruiting ID
American Society for Nutrition Foundation (Other)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Infant fruit
  • Other: Infant vegetable
  • Other: Infant meat
  • Other: Infant grain

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 (rice 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 Design

Study Type:
Anticipated Enrollment :
40 participants
Intervention Model:
Parallel Assignment
Single (Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Effect of First Complementary Foods on the Infant Gastrointestinal Microbiota: A Pilot Study
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Infant cereal

Rice cereal

Other: Infant grain
Infants will be fed rice 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

Outcome Measures

Primary Outcome Measures

  1. Change in gastrointestinal microbiota [Day 0, 4, 8, 12, 16, 20, 24, 28]

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

Eligibility Criteria


Ages Eligible for Study:
5 Months to 7 Months
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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 allergy to one or more of the four intervention foods (rice cereal, beef & gravy, prune, carrot)

Contacts and Locations


Site City State Country Postal Code
1 University of Delaware Newark Delaware United States 19713

Sponsors and Collaborators

  • University of Delaware
  • American Society for Nutrition Foundation


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

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Jill Trabulsi, Associate Professor, University of Delaware Identifier:
Other Study ID Numbers:
  • 1889964-1
First Posted:
Aug 8, 2022
Last Update Posted:
Aug 8, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Jill Trabulsi, Associate Professor, University of Delaware

Study Results

No Results Posted as of Aug 8, 2022