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The Effect of Anemia in Infancy on the Microbiome and Systemic Metabolism

Development of Infants and Young Children Living in the Amazon Region of Peru: Relationship With Anemia, Chronic Malnutrition, and Gut Microbiota.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03377777
Enrollment
203
Registered
2017-12-19
Start date
2014-08-01
Completion date
2014-11-30
Last updated
2018-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Iron-deficiency, Iron Deficiency Anemia

Keywords

Anemia, Iron-deficiency, Iron-deficiency anemia, Infants, Metabolomics, Microbiome

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.

Interventions

OTHERNo intervention

Sponsors

Universidad Peruana Cayetano Heredia
CollaboratorOTHER
Asociacion Civil Selva Amazonica
CollaboratorOTHER
University of California, Davis
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
6 Months to 13 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Anemia status6-7 months or 12-13 monthsAnemia status \[Hb\] ≤ 110 g/L

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026