Clinical trial NCT03377777: The Effect of Anemia in Infancy on the Microbiome and Systemic Metabolism
Official title: Development of Infants and Young Children Living in the Amazon Region of Peru: Relationship With Anemia, Chronic Malnutrition, and Gut Microbiota.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Iron-deficiency
Iron Deficiency Anemia
Keywords: Anemia
Iron-deficiency
Iron-deficiency anemia
Infants
Metabolomics
Microbiome
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Universidad Peruana Cayetano Heredia
name: Asociacion Civil Selva Amazonica
First posted: 2017-12-19
Enrollment: 203
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outwardly healthy 6-7 month, and 12-13 month male and female infants born at term with a birthweight \> 2,500 g.

Brief summary: Serum and fecal samples were collected from infants at either 6-7 m of age or 12-13 m of age. Serum and feces were analyzed locally for hemoglobin status or evidence of parasites, and standard of care was provided. Excess serum was transported to UC Davis for metabolomics analysis and the University of Hohenheim for iron status assessment and measurement of inflammatory markers. Fecal samples were transported to UC Davis for measurement of the microbiome structure and function.

Detailed description: Sample collection occurred between August and November 2014. A total of 203 infants and their parents (101 at 6-7 m of age and 102 at 12-13 m of age) receiving care at the Moronacocha Health Center in Iquitos, Peru were recruited. All subjects were residents of Moronochocha, Iquitos, Loreto, outwardly healthy, and born at term with a birth weight of at least 2,500 g. Venous blood samples were collected by a lab technician at the local health center. Hemoglobin concentrations were immediately measured, and treatment given if warranted. Samples were subsequently transported to Selva Amazonica clinic, centrifuged, and serum was stored at -80 °C. Stool samples were collected by caregivers from diapers at home, taken to Selva Amazonica Clinic, and aliquoted. Fecal samples were analyzed for parasites at Selva Amazonica, and any necessary treatment was provided at the local health center. Serum and stool samples were shipped to UC Davis on dry ice, where they were stored at -80 °C until metabolomics and microbiome analyses. Serum aliquots were also shipped to the University of Hohenheim, Stuttgart, Germany for iron assessment, and measurement of inflammatory markers. All data integration and interpretation was performed at UC Davis.

Eligibility criteria: Inclusion Criteria:

* Outwardly healthy,
* birthweight \> 2,500 g
* term births
* residents in Moronacocha, Iquitos, Loreto

Exclusion Criteria:

* Obvious signs of illness or malnutrition
* birthweight \< 2,500 g
* preterm birth
* not a resident of Moronacocha, Iquitos, Loreto

Primary outcomes:
measure: Anemia status
timeFrame: 6-7 months or 12-13 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: McClorry S, Zavaleta N, Llanos A, Casapia M, Lonnerdal B, Slupsky CM. Anemia in infancy is associated with alterations in systemic metabolism and microbial structure and function in a sex-specific manner: an observational study. Am J Clin Nutr. 2018 Dec 1;108(6):1238-1248. doi: 10.1093/ajcn/nqy249.