Recruiting

Gut Microbiota

Sponsor:

University of Colorado, Denver

Code:

NCT03828708

Conditions

Infant Development

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

Iron in infant formula

Study Details

Brief summary:

This study will look at the amount of iron in infant formula and how that affects a child's gut development. The children of mothers who plan to formula feed their children will be randomized to receive either high iron or low iron formula from birth until 4 months of age. Infants will consume only the study provided formula during enrollment. Blood and stool samples will be collected at birth and end of study to measure the effects of the iron exposure. The overall object is to compare high iron versus low iron exposure in formula-fed infants during the first months of life. Aims include determining the types of bacteria that are present in the infants' fecal microbiome, determining the effect of high iron exposure on gut microbiome and sleep patterns, and comparing iron status and homeostasis between the low and high iron formula groups.

Conditions

Infant Development

Study ID

NCT03828708

Start date

Sep 28, 2021

Status verified date

Feb, 2023

Completion date

May, 2024

Anticipated

Primary completion date

May, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Healthy new born infants

Exclusion Criteria:

  • Newborn infants with conditions that prohibit cow-milk based formula consumption

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Standard iron arm

Participants randomized to this arm will consume infant formula containing 12 mg/L of iron, equivalent to the standard iron content in U.S. infant formula

experimental: Low iron arm

Participants randomized to this arm will consume infant formula containing 5 mg/L of iron, equivalent to the standard iron content in European infant formula

Interventions

Iron in infant formula

Participants will receive the same low-iron (5 mg/L) infant formula. Infants in the standard iron group will add iron supplement to pre-made infant formula so the iron content will be 12 mg/L.

Primary outcome measure

  • Gut microbiota [ Time Frame: birth to 4 months of age ]

Central Contacts and Locations

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

More Information

Sponsor

University of Colorado, Denver

Last update posted

Feb 2, 2023

Last verified

Feb, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2023-02-02.