The Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction in Rural Malawian Children 1-3 Year Olds

Environmental Enteropathy Clinical Trial

Official title:

Randomized, Single-blinded, Prospective Clinical Trial Comparing the Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction and Stunting in Rural Malawian Children 1-3 Year Olds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02472301
• Other study ID #: LG2
• Status: Completed
• Phase: N/A
• First received: June 9, 2015
• Last updated: May 10, 2017
• Start date: August 2015
• Est. completion date: December 2016

Study information

• Verified date: May 2017
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine if 12 months of legume-based complementary foods is effective in reducing or reversing EED and linear growth faltering in a cohort of Malawian children, aged 12-35 months to see if these improvements are correlated with specific changes in the enteric microbiome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 337
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 35 Months

Eligibility

Inclusion Criteria:

• children residing in catchment area of Limela, Machinga District and N tenda (Chikwawa District), Malawi

• aged 12-35 months

• youngest eligible child in each household

Exclusion Criteria:Unable to drink 20 mL of sugar water

• Demonstrating evidence of severe acute malnutrition, WHZ < or = -3, presence of bi-pedal pitting edema

• Apparent need for acute medical treatment for an illness or injury

• Caregiver refusal to participate and return for 3, 6 and 12 month follow-ups

Related Conditions & MeSH terms

• Environmental Enteropathy
• Intestinal Diseases

Intervention

Dietary Supplement:
• cowpeas complementary food
cowpeas supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
• corn-soy flour
Corn-soy flour supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
• common bean complementary food
common bean supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.

Locations

Country	Name	City	State
n/a

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	Dual Sugar Absorption Test	lactulose-mannitol ratio in urine	3 months
Primary	Dual Sugar Absorption Test	lactulose-mannitol ratio in urine	6 months
Primary	Dual Sugar Absorption Test	lactulose-mannitol ratio in urine	12 months
Secondary	Lactulose Excretion	percentage of ingested lactulose excreted in urine	3 months
Secondary	Lactulose Excretion	percentage of ingested lactulose excreted in urine	6 months
Secondary	Lactulose Excretion	percentage of ingested lactulose excreted in urine	12 months
Secondary	Mannitol Excretion	percentage of ingested mannitol excreted in urine	3 months
Secondary	Mannitol Excretion	percentage of ingested mannitol excreted in urine	6 months
Secondary	Mannitol Excretion	percentage of ingested mannitol excreted in urine	12 months