First Complementary Foods and the Infant Gastrointestinal Microbiota

Sponsor

University of Delaware (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05492253

Collaborator

American Society for Nutrition Foundation (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

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
Healthy Participants Infants Gastrointestinal Microbiota	Other: Infant fruit Other: Infant vegetable Other: Infant meat Other: Infant grain	N/A

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:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

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

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

Criteria

Ages Eligible for Study:

5 Months to 7 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jill Trabulsi, Associate Professor, University of Delaware

ClinicalTrials.gov Identifier:

NCT05492253

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

Healthy term infant

Complementary diet

Gastrointestinal microbiota

Study Results

No Results Posted as of Aug 8, 2022