Early Iron Exposure on the Gut Microbiota in Young Infants

Infant Development Clinical Trial

— IF  

Official title:

Different Iron Exposure on the Development of Gut Microbiota From Birth to Four Months

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03828708
• Other study ID #: 18-1317
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2021
• Est. completion date: May 2024

Study information

• Verified date: February 2023
• Source: University of Colorado, Denver
• Contact: Minghua Tang, PhD
• Phone: 7653377572
• Email: minghua.tang[@]ucdenver.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 4 Months

Eligibility

Inclusion Criteria:

• Healthy new born infants

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Infant Development

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut microbiota	the gut microbial structure of the participants, by stool samples collected	birth to 4 months of age
Secondary	Iron status: soluble transferrin receptor	Soluble transferrin receptors are proteins found in blood that can be elevated with iron deficiency.	at baseline (birth) and end of intervention (4 months)
Secondary	Iron status: ferritin	A ferritin blood test shows how much iron is stored in your body.	at baseline (birth) and end of intervention (4 months)
Secondary	Iron status: hepcidin	Hepcidin is a regulator of iron metabolism.	at baseline (birth) and end of intervention (4 months)
Secondary	Inflammation: c-reactive protein	C-reactive protein (CRP) is a substance produced by the liver in response to inflammation.	at baseline (birth) and end of intervention (4 months)
Secondary	Immunity: soluble CD14	biomarker of innate immunity	at baseline (birth) and end of intervention (4 months)
Secondary	Sleep patterns: duration	Participants will wear a device (Micro Motionlogger Watch version 734) to provide objective measurements of duration.	end of intervention (4 months)