Early Iron Exposure on the Gut Microbiota in Young Infants

Not Applicable

Recruiting

• Conditions: Infant Development
• Interventions: Other: Iron in infant formula

• Registration Number: NCT03828708
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Disturbance of the gut microbial colonization during infancy may result in long-term programming impact of metabolism and disease risks of the host. The early gut microbial colonization coincides with the maturation of the infant's mucosal innate immune system and research showed that the gut microbial dysbiosis is associated with impaired innate immune development. Thus, ensuring proper microbial colonization early in life is critical to the maturation of the immune system and long-term health.

Iron fortification can increase the abundance of pathogenic bacteria and induce inflammation in older infants. However, it is still not known what the effect of iron is on a more vulnerable population: the newborn infant, who has immature immune system. Infants 0-4 months are at a low risk for iron deficiency due to the iron endowment at birth, which is compatible with the very low iron content (\<0.5mg Fe/L) in breastmilk. However, commercial infant formulas are all fortified with ≥12mg Fe/L. Whether this striking difference drives adverse health effects is unknown/unexamined, especially on early colonization and immune homeostasis. The overall objective is to determine the impact of high vs. low iron exposure in formula-fed infants during the early post-natal months on gut microbiome.

Study Timeline

• Study First Submitted: 2019-01-30
• Study First Submitted QC: 2019-01-31
• Study First Posted: 2019-02-04
• Study Start: 2021-09-28
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-01
• Last Update Posted: 2023-02-02
• Primary Completion: 2024-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Healthy new born infants

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard iron arm	Iron in infant formula	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
Low iron arm	Iron in infant formula	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

Primary Outcome Measures

Name	Time	Method
Gut microbiota	birth to 4 months of age	the gut microbial structure of the participants, by stool samples collected

Secondary Outcome Measures

Name	Time	Method
Iron status: ferritin	at baseline (birth) and end of intervention (4 months)	A ferritin blood test shows how much iron is stored in your body.
Immunity: soluble CD14	at baseline (birth) and end of intervention (4 months)	biomarker of innate immunity
Inflammation: c-reactive protein	at baseline (birth) and end of intervention (4 months)	C-reactive protein (CRP) is a substance produced by the liver in response to inflammation.
Iron status: soluble transferrin receptor	at baseline (birth) and end of intervention (4 months)	Soluble transferrin receptors are proteins found in blood that can be elevated with iron deficiency.
Iron status: hepcidin	at baseline (birth) and end of intervention (4 months)	Hepcidin is a regulator of iron metabolism.
Sleep patterns: duration	end of intervention (4 months)	Participants will wear a device (Micro Motionlogger Watch version 734) to provide objective measurements of duration.

Trial Locations

Locations (1)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States