Clinical trial NCT02472262: The Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction in Rural Malawian Children 6-11 Months
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enteropathy
Keywords: Environmental
Enteric
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2015-06-15
Enrollment: 355
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

-

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 -

-

Primary outcomes:
measure: Change in Length-for-age z Score Over 6 Months From Enrollment to End of Study.
timeFrame: 6 months
measure: % Lactulose From Dual Sugar Absorption Test at 9 and 12 Months of Age
timeFrame: 6 month
Secondary outcomes:
measure: 16S Configuration of Fecal Microbiota at 6.5, 7.5, 9, 10.5 and 12 Months of Age Comparing Supplementary Food Groups
timeFrame: 6 months
measure: Mid-upper Arm Circumference at 9 and 12 Months of Age
timeFrame: 6 months
measure: Weight-for-height z Score at 9 and 12 Months of Age
timeFrame: 6 months
measure: Association of 16S Configuration of Fecal Microbiome With Demographic, Anthropometric, Intestinal Permeability, Sanitation and Antibiotic Exposure Characteristics of the Study Population
timeFrame: 6 months
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: University of Malawi
Study officials:
affiliation: Washington University School of Medince
name: Mark Manary, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.