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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03377777
Recruitment Status : Completed
First Posted : December 19, 2017
Last Update Posted : January 30, 2018
Universidad Peruana Cayetano Heredia
Asociacion Civil Selva Amazonica
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease Intervention/treatment
Anemia Iron-deficiency Iron Deficiency Anemia Other: No intervention

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.

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Study Type : Observational
Actual Enrollment : 203 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Development of Infants and Young Children Living in the Amazon Region of Peru: Relationship With Anemia, Chronic Malnutrition, and Gut Microbiota.
Actual Study Start Date : August 1, 2014
Actual Primary Completion Date : November 30, 2014
Actual Study Completion Date : November 30, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Group/Cohort Intervention/treatment
Outwardly healthy male and female infants at 6-7 months or 12-13 months. No intervention.
Other: No intervention

Primary Outcome Measures :
  1. Anemia status [ Time Frame: 6-7 months or 12-13 months ]
    Anemia status [Hb] ≤ 110 g/L

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 13 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of California, Davis Identifier: NCT03377777    
Other Study ID Numbers: GAIN08112014
00000000 ( Other Identifier: UCDavis IRB exempt )
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Microbiome sequencing data will be shared in a public repository (with iron status included as meta data).
Time Frame: Once study has been published
Access Criteria: Publicly available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, Davis:
Iron-deficiency anemia
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases