Pilot Feasibility of Rice Bran Supplementation in Children

Completed · Not applicable

Conditions studied: Dietary Rice Bran Supplementation

In brief

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.

Key facts

Study ID

NCT02557373

Run by

Colorado State University

People needed

48

Starts

2015-08-01

Expected to finish

2016-05-01

Last updated by the study team

2017-07-21

Who can join

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

You may qualify if…

• Children between the ages of 4-6 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

You may not qualify if…

• 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

Where it is running

• Colorado State University — Fort Collins, Colorado, United States
• University of Science, Techniques and Technologies of Bamako — Bamako, Mali

Full record on ClinicalTrials.gov

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