Expired Study
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Fort Collins, Colorado 80523


Purpose:

The purpose of this study is to assess feasibility of rice bran consumption in weaning children and to identify dietary rice bran mediated changes to the stool microbiome and stool metabolome.


Study summary:

Rice bran is a globally accessible, underutilized food ingredient with an array of beneficial nutrients (e.g. phytochemicals and prebiotics) that promote health and potentially prevent diseases. The investigators will determine if dietary rice bran intake can modulate the infant gut microbiome and metabolome to promote gut immunity for the benefit of preventing diarrheal diseases that increase risk for malnutrition and stunting. The investigators hope to learn about the feasibility of dietary supplementation of heat-stabilized rice bran in weaning children living in regions with increased susceptibility to diarrhea and malnutrition, and whether or not rice bran consumption can modulate the stool microbiome and metabolome.


Criteria:

Inclusion Criteria: - Children between the ages of 4-6 months at beginning of recruitment - Families willing to feed their infant a daily dose of study-provided heat-stabilized rice bran supplementation for 3 months - Hemoglobin level >7 g/dl - Absence of intestinal parasites or malaria infection - Have not yet received Vitamin A supplementation Exclusion Criteria: - Have had a diarrheal episode between 5 and 6 months of age - Have had a prior hospitalization - Have had an antibiotic or prophylactic treatment within 1 month prior to participation - Have an ongoing illness, a known immunocompromising condition, or use of medications - Hemoglobin level <7 g/dl - Presence of intestinal parasites or malaria infection


NCT ID:

NCT02557373


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Fort Collins, Colorado 80523
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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