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Completed

NCT Number: NCT05492253

First Complementary Foods and the Infant Gastrointestinal Microbiota

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

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Key information

Age range

5 month–7 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Delaware

Newark, Delaware, 19713, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Infant fruit

Other

Infants will be fed prune puree

Infant vegetable

Other

Infants will be fed carrot puree

Infant meat

Other

Infants will be fed beef puree

Infant grain

Other

Infants will be fed oatmeal cereal

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Collaborators

  • American Society for Nutrition

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 8, 2022
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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