NCT Number: NCT03377777
The Effect of Anemia in Infancy on the Microbiome and Systemic Metabolism
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.
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Conditions
Age range
6 month–13 month
Sex eligibility
All sexes
Study type
Observational
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Anemia status
Time frame: 6-7 months or 12-13 months
Anemia status [Hb] ≤ 110 g/L
Sponsors and collaborators
Lead sponsor
University of California, Davis
Other
Collaborators
- Asociacion Civil Selva Amazonica
- Universidad Peruana Cayetano Heredia
Registry information
Official study title
Development of Infants and Young Children Living in the Amazon Region of Peru: Relationship With Anemia, Chronic Malnutrition, and Gut Microbiota.
Important dates
- Study start
- 2014
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Dec 19, 2017
- Registry last updated
- Jan 30, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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