NCT02472262

The Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction in Rural Malawian Children 6-11 Months

Randomized, Single-blinded, Prospective Clinical Trials Comparing the Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction and Stunting in Rural Malawian Children 6-11 Months

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 355 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 5 Months – 12 Months
• Healthy volunteers: Accepted

Summary

To determine if 6 months of legume-based complementary foods is effective in reducing or reversing EED and linear growth faltering in a cohort of Malawian children, aged 6-11 months to see if these improvements are correlated with specific changes in the enteric microbiome.

Conditions

• Enteropathy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Cow pea complementary food	A legume-based complementary food made from cowpeas will be given for 6 months, 200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.
DIETARY_SUPPLEMENT	Corn soy flour	Corn flour with 10% soy will be given for 6 months, 200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.
DIETARY_SUPPLEMENT	Common bean	A legume-based complementary food made from common beans will be given for 6 months,200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-06-15
• Last updated: 2019-12-02
• Results posted: 2019-11-13

Locations

1 site across 1 country: Malawi