Clinical trial NCT02472301: The Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction in Rural Malawian Children 1-3 Year Olds
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Environmental Enteropathy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2015-06-15
Enrollment: 337
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Dual Sugar Absorption Test
timeFrame: 3 months
measure: Dual Sugar Absorption Test
timeFrame: 6 months
measure: Dual Sugar Absorption Test
timeFrame: 12 months
Secondary outcomes:
measure: Lactulose Excretion
timeFrame: 3 months
measure: Lactulose Excretion
timeFrame: 6 months
measure: Lactulose Excretion
timeFrame: 12 months
measure: Mannitol Excretion
timeFrame: 3 months
measure: Mannitol Excretion
timeFrame: 6 months
measure: Mannitol Excretion
timeFrame: 12 months
Other outcomes:
Locations:
city: Blantyre
country: Malawi
Study officials:
affiliation: Washington University School of Medince
name: Mark Manary, MD
role: PRINCIPAL_INVESTIGATOR
References:
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: Agapova SE, Stephenson KB, Divala O, Kaimila Y, Maleta KM, Thakwalakwa C, Ordiz MI, Trehan I, Manary MJ. Additional Common Bean in the Diet of Malawian Children Does Not Affect Linear Growth, but Reduces Intestinal Permeability. J Nutr. 2018 Feb 1;148(2):267-274. doi: 10.1093/jn/nxx013.
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.