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

Enteropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02472262
• Other study ID #: LG1
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: December 2016

Study information

• Verified date: November 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Months to 12 Months

Eligibility

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

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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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Related Conditions & MeSH terms

• Enteropathy
• Intestinal Diseases

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Malawi	University of Malawi	Blantyre

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Length-for-age z Score Over 6 Months From Enrollment to End of Study.	Change in length-for-age z score from enrollment to end of study 6 months	6 months
Primary	% Lactulose From Dual Sugar Absorption Test at 9 and 12 Months of Age	percent of lactulose found in urine during the dual sugar absorption test	6 month
Secondary	16S Configuration of Fecal Microbiota at 6.5, 7.5, 9, 10.5 and 12 Months of Age Comparing Supplementary Food Groups		6 months
Secondary	Mid-upper Arm Circumference at 9 and 12 Months of Age	Mid-upper arm circumference in cm	6 months
Secondary	Weight-for-height z Score at 9 and 12 Months of Age	weight for height z-score at 9 and 12 months of age	6 months
Secondary	Association of 16S Configuration of Fecal Microbiome With Demographic, Anthropometric, Intestinal Permeability, Sanitation and Antibiotic Exposure Characteristics of the Study Population		6 months