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Completed

NCT Number: NCT02472301

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

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.

Completed

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Key information

Conditions

Environmental Enteropathy

Age range

12 month–35 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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 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

Treatment and study plan

cowpeas complementary food

Dietary Supplement

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

Dietary Supplement

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

Dietary Supplement

common bean supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.

Primary outcomes

  1. Dual Sugar Absorption Test

    Time frame: 3 months

    lactulose-mannitol ratio in urine

  2. Dual Sugar Absorption Test

    Time frame: 6 months

    lactulose-mannitol ratio in urine

  3. Dual Sugar Absorption Test

    Time frame: 12 months

    lactulose-mannitol ratio in urine

Secondary outcomes

  1. Lactulose Excretion

    Time frame: 3 months

    percentage of ingested lactulose excreted in urine

  2. Lactulose Excretion

    Time frame: 6 months

    percentage of ingested lactulose excreted in urine

  3. Lactulose Excretion

    Time frame: 12 months

    percentage of ingested lactulose excreted in urine

  4. Mannitol Excretion

    Time frame: 3 months

    percentage of ingested mannitol excreted in urine

  5. Mannitol Excretion

    Time frame: 6 months

    percentage of ingested mannitol excreted in urine

  6. Mannitol Excretion

    Time frame: 12 months

    percentage of ingested mannitol excreted in urine

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 15, 2015
Registry last updated
May 11, 2017

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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