NCT02472262

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
355

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 15, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
3 years until next milestone

Results Posted

Study results publicly available

November 13, 2019

Completed
Last Updated

December 2, 2019

Status Verified

November 1, 2019

Enrollment Period

1.3 years

First QC Date

June 8, 2015

Results QC Date

October 22, 2019

Last Update Submit

November 18, 2019

Conditions

Enteropathy

Keywords

EnvironmentalEnteric

Outcome Measures

Primary Outcomes (2)

  • 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

  • % 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 Outcomes (4)

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

    6 months

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

    6 months

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

    6 months

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

    6 months

Study Arms (3)

Cow pea complementary food

EXPERIMENTAL

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

Common bean

EXPERIMENTAL

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

Corn Soy Flour

ACTIVE COMPARATOR

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

Interventions

Cow pea complementary foodDIETARY_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.

Cow pea complementary food
Corn soy flourDIETARY_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.

Corn Soy Flour
Common beanDIETARY_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.

Common bean

Eligibility Criteria

Age5 Months - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • children residing in catchment area of Limela, Machinga District and Ntenda (Chikwawa District), Malawi aged 6-11 months youngest eligible child in each household

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Malawi

Blantyre, Malawi

Location

Related Publications (6)

  • Ordiz MI, Janssen S, Humphrey G, Ackermann G, Stephenson K, Agapova S, Divala O, Kaimila Y, Maleta K, Zhong C, Knight R, Trehan I, Tarr PI, Rusconi B, Manary MJ. The effect of legume supplementation on the gut microbiota in rural Malawian infants aged 6 to 12 months. Am J Clin Nutr. 2020 Apr 1;111(4):884-892. doi: 10.1093/ajcn/nqaa011.

    PMID: 32047925DERIVED

  • Ordiz MI, Semba RD, Moaddel R, Rolle-Kampczyk U, von Bergen M, Herberth G, Khadeer M, Roder S, Manary MJ. Serum Amino Acid Concentrations in Infants from Malawi are Associated with Linear Growth. Curr Dev Nutr. 2019 Aug 29;3(10):nzz100. doi: 10.1093/cdn/nzz100. eCollection 2019 Oct.

    PMID: 31620672DERIVED

  • Kaimila Y, Pitman RT, Divala O, Hendrixson DT, Stephenson KB, Agapova S, Trehan I, Maleta K, Manary MJ. Development of Acute Malnutrition Despite Nutritional Supplementation in Malawi. J Pediatr Gastroenterol Nutr. 2019 May;68(5):734-737. doi: 10.1097/MPG.0000000000002241.

    PMID: 31022095DERIVED

  • Borresen EC, Zhang L, Trehan I, Nealon NJ, Maleta KM, Manary MJ, Ryan EP. The Nutrient and Metabolite Profile of 3 Complementary Legume Foods with Potential to Improve Gut Health in Rural Malawian Children. Curr Dev Nutr. 2017 Sep 21;1(10):e001610. doi: 10.3945/cdn.117.001610. eCollection 2017 Oct.

    PMID: 29955682DERIVED

  • Stephenson KB, Agapova SE, Divala O, Kaimila Y, Maleta KM, Thakwalakwa C, Ordiz MI, Trehan I, Manary MJ. Complementary feeding with cowpea reduces growth faltering in rural Malawian infants: a blind, randomized controlled clinical trial. Am J Clin Nutr. 2017 Dec;106(6):1500-1507. doi: 10.3945/ajcn.117.160986. Epub 2017 Nov 1.

    PMID: 29092882DERIVED

  • Trehan I, Benzoni NS, Wang AZ, Bollinger LB, Ngoma TN, Chimimba UK, Stephenson KB, Agapova SE, Maleta KM, Manary MJ. Common beans and cowpeas as complementary foods to reduce environmental enteric dysfunction and stunting in Malawian children: study protocol for two randomized controlled trials. Trials. 2015 Nov 14;16:520. doi: 10.1186/s13063-015-1027-0.

    PMID: 26578308DERIVED

MeSH Terms

Conditions

Intestinal Diseases

Interventions

alpha-amylase inhibitor, Phaseolus vulgaris

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Results Point of Contact

Title
Mark Manary
Organization
Washington University School of Medicine in St. Louis
manarymj@wustl.edu
3144542178

Study Officials

  • Mark Manary, MD

    Washington University School of Medince

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2015

First Posted

June 15, 2015

Study Start

August 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 2, 2019

Results First Posted

November 13, 2019

Record last verified: 2019-11

Locations

MA(1)