First Complementary Foods and the Infant Gastrointestinal Microbiota

Study Overview
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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.

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.

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

Conditions
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Healthy Participants, Infants, Gastrointestinal Microbiota

Intervention / Treatment
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* Other: Infant fruit
* Other: Infant vegetable
* Other: Infant meat
* Other: Infant grain


Participation Criteria
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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 Exclusion Criteria: Infant is not developmentally ready to begin solid foods Infant has a family history of food allergy

Ages Eligible for Study
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Minimum Age: 5 Months
Maximum Age: 7 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in gastrointestinal microbiota | Composition of the gastrointestinal microbiota (family, genus, and species levels via shotgun metagenomic sequencing) before and after the introduction of solid food | Day 0, 2, 4, 6, 8, 10, 12, 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy term infant, Complementary diet, Gastrointestinal microbiota