Early Iron Exposure on the Gut Microbiota in Young Infants
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/9/2019 |
| Start Date: | February 20, 2019 |
| End Date: | June 30, 2021 |
| Contact: | Minghua Tang, PhD |
| Email: | minghua.tang@ucdenver.edu |
| Phone: | 7653377572 |
Different Iron Exposure on the Development of Gut Microbiota From Birth to Four Months
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.
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.
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.
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.
Inclusion Criteria:
- Healthy new born infants
Exclusion Criteria:
- Newborn infants with conditions that prohibit cow-milk based formula consumption
We found this trial at
1
site
13001 E 17th Pl
Aurora, Colorado 80045
Aurora, Colorado 80045
(303) 724-5000
Phone: 303-724-3248
University of Colorado Anschutz Medical Campus Located in the Denver metro area near the Rocky...
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