Pilot Feasibility of Rice Bran Supplementation in Nicaraguan Children

Completed · Not applicable

Conditions studied: Dietary Rice Bran Supplementation

In brief

The purpose is to assess feasibility of rice bran consumption in weaning children and collect pilot data on gut microbiome and metabolome modulation with rice bran intake for diarrheal prevention.

Key facts

Study ID

NCT02615886

Run by

Colorado State University

People needed

47

Starts

2014-11-01

Expected to finish

2015-10-01

Last updated by the study team

2017-07-19

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Children between the ages of 4 months and 6 months at beginning of recruitment
• Have received the 3 doses of the rotavirus vaccination (RV5)
• Families willing to feed their infant a daily dose of study-provided heat-stabilized rice bran for 6 months

You may not qualify if…

• Have had a diarrheal episode between 4 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

Where it is running

• Colorado State University — Fort Collins, Colorado, United States
• National Autonomous University of Nicaragua, León — León, Nicaragua

Full record on ClinicalTrials.gov

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