First Complementary Foods and the Infant Gastrointestinal Microbiota

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-30

Study Completion Date

2024-03-12

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy Participants Infants Gastrointestinal Microbiota

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Infant cereal

Oatmeal cereal

Group Type ACTIVE_COMPARATOR

Infant grain

Intervention Type OTHER

Infants will be fed oatmeal cereal

Infant fruit

Pureed prunes

Group Type EXPERIMENTAL

Infant fruit

Intervention Type OTHER

Infants will be fed prune puree

Infant vegetable

Pureed carrots

Group Type EXPERIMENTAL

Infant vegetable

Intervention Type OTHER

Infants will be fed carrot puree

Infant meat

Pureed beef

Group Type EXPERIMENTAL

Infant meat

Intervention Type OTHER

Infants will be fed beef puree

Interventions

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Infant fruit

Infants will be fed prune puree

Intervention Type OTHER

Infant vegetable

Infants will be fed carrot puree

Intervention Type OTHER

Infant meat

Infants will be fed beef puree

Intervention Type OTHER

Infant grain

Infants will be fed oatmeal cereal

Intervention Type OTHER

Eligibility Criteria

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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