Clinical trial NCT03828708: Early Iron Exposure on the Gut Microbiota in Young Infants
Official title: Different Iron Exposure on the Development of Gut Microbiota From Birth to Four Months
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infant Development
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to one of the two groups with different amount of iron consumed.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

* Healthy new born infants

Exclusion Criteria:

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

Primary outcomes:
measure: Gut microbiota
timeFrame: birth to 4 months of age
Secondary outcomes:
measure: Iron status: soluble transferrin receptor
timeFrame: at baseline (birth) and end of intervention (4 months)
measure: Iron status: ferritin
timeFrame: at baseline (birth) and end of intervention (4 months)
measure: Iron status: hepcidin
timeFrame: at baseline (birth) and end of intervention (4 months)
measure: Inflammation: c-reactive protein
timeFrame: at baseline (birth) and end of intervention (4 months)
measure: Immunity: soluble CD14
timeFrame: at baseline (birth) and end of intervention (4 months)
measure: Sleep patterns: duration
timeFrame: end of intervention (4 months)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Minghua Tang, PhD
role: PRINCIPAL_INVESTIGATOR
References: