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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03377777
• Other study ID #: GAIN08112014
• Secondary ID: 00000000
• Status: Completed
• Phase: N/A
• First received: December 11, 2017
• Last updated: January 26, 2018
• Start date: August 1, 2014
• Est. completion date: November 30, 2014

Study information

• Verified date: January 2018
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: November 30, 2014
• Est. primary completion date: November 30, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 13 Months

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Iron Deficiency Anemia
• Iron-deficiency

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Davis	Asociacion Civil Selva Amazonica, Universidad Peruana Cayetano Heredia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anemia status	Anemia status [Hb] = 110 g/L	6-7 months or 12-13 months