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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02472262
Recruitment Status : Completed
First Posted : June 15, 2015
Results First Posted : November 13, 2019
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Enteropathy Dietary Supplement: Cow pea complementary food Dietary Supplement: Corn soy flour Dietary Supplement: Common bean Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 355 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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
Actual Study Start Date : August 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: 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.
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.

Experimental: 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.
Dietary Supplement: 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.

Active Comparator: 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.
Dietary Supplement: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02472262


Locations
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Malawi
University of Malawi
Blantyre, Malawi
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Mark Manary, MD Washington University School of Medince

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02472262    
Other Study ID Numbers: LG1
First Posted: June 15, 2015    Key Record Dates
Results First Posted: November 13, 2019
Last Update Posted: December 2, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Washington University School of Medicine:
Environmental
Enteric
Additional relevant MeSH terms:
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Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases