N/A N=355 Randomized Double-blind Treatment

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

Enteropathy

Bottom Line

View on ClinicalTrials.gov: NCT02472262 ↗

Enrolled (actual)

355

Serious AEs

0.0%

Results posted

Nov 2019

Primary outcome: Primary: Change in Length-for-age z Score Over 6 Months From Enrollment to End of Study. — -0.14; -0.27; -0.27 z-score

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Cow pea complementary food (Dietary_supplement); Corn soy flour (Dietary_supplement); Common bean (Dietary_supplement)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Washington University School of Medicine
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Length-for-age z Score Over 6 Months From Enrollment to End of Study.	-0.14; -0.27; -0.27	—
PRIMARY % Lactulose From Dual Sugar Absorption Test at 9 and 12 Months of Age	—	—
SECONDARY 16S Configuration of Fecal Microbiota at 6.5, 7.5, 9, 10.5 and 12 Months of Age Comparing Supplementary Food Groups	—	—
SECONDARY Mid-upper Arm Circumference at 9 and 12 Months of Age	—	—
SECONDARY Weight-for-height z Score at 9 and 12 Months of Age	—	—
SECONDARY Association of 16S Configuration of Fecal Microbiome With Demographic, Anthropometric, Intestinal Permeability, Sanitation and Antibiotic Exposure Characteristics of the Study Population	—	—

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.

Eligibility Criteria

Inclusion Criteria

children residing in catchment area of Limela, Machinga District and Ntenda (Chikwawa District), Malawi aged 6-11 months youngest eligible child in each household

Exclusion Criteria

Unable to drink 20 mL of sugar water Demonstrating evidence of severe acute malnutrition Apparent need for acute medical treatment for an illness or injury Caregiver refusal to participate and return for 3 and 6 month follow-ups -

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Data sourced from ClinicalTrials.gov (NCT02472262). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.