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Completed

NCT Number: NCT02472262

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

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.

Completed

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Key information

Conditions

Enteropathy Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

5 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Malawi

Blantyre, Malawi

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 -

-

Treatment and study plan

Cow pea complementary food

Dietary Supplement

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

Dietary Supplement

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

Dietary Supplement

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.

Primary outcomes

  1. Change in Length-for-age z Score Over 6 Months From Enrollment to End of Study.

    Time frame: 6 months

    Change in length-for-age z score from enrollment to end of study 6 months

  2. % Lactulose From Dual Sugar Absorption Test at 9 and 12 Months of Age

    Time frame: 6 month

    percent of lactulose found in urine during the dual sugar absorption test

Secondary outcomes

  1. 16S Configuration of Fecal Microbiota at 6.5, 7.5, 9, 10.5 and 12 Months of Age Comparing Supplementary Food Groups

    Time frame: 6 months

  2. Mid-upper Arm Circumference at 9 and 12 Months of Age

    Time frame: 6 months

    Mid-upper arm circumference in cm

  3. Weight-for-height z Score at 9 and 12 Months of Age

    Time frame: 6 months

    weight for height z-score at 9 and 12 months of age

  4. Association of 16S Configuration of Fecal Microbiome With Demographic, Anthropometric, Intestinal Permeability, Sanitation and Antibiotic Exposure Characteristics of the Study Population

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 15, 2015
Registry last updated
Dec 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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