Enteropathy
Conditions
Keywords
Environmental, Enteric
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.
Interventions
DIETARY_SUPPLEMENTCow 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_SUPPLEMENTCorn 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_SUPPLEMENTCommon 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.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
5 Months to 12 Months
Healthy volunteers
Yes
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 - \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Length-for-age z Score Over 6 Months From Enrollment to End of Study. | 6 months | Change in length-for-age z score from enrollment to end of study 6 months |
| % Lactulose From Dual Sugar Absorption Test at 9 and 12 Months of Age | 6 month | percent of lactulose found in urine during the dual sugar absorption test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Mid-upper arm circumference in cm |
| Weight-for-height z Score at 9 and 12 Months of Age | 6 months | weight for height z-score at 9 and 12 months of age |
| Association of 16S Configuration of Fecal Microbiome With Demographic, Anthropometric, Intestinal Permeability, Sanitation and Antibiotic Exposure Characteristics of the Study Population | 6 months | — |
Countries
Malawi
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 117 |
| 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.
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. | 120 |
| 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.
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. | 118 |
| Total | 355 |
Baseline characteristics
| Characteristic | Common Bean | Corn Soy Flour | Cow Pea Complementary Food | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 120 Participants | 118 Participants | 117 Participants | 355 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 5.8 months STANDARD_DEVIATION 0.3 | 5.8 months STANDARD_DEVIATION 0.4 | 5.8 months STANDARD_DEVIATION 0.3 | 5.8 months STANDARD_DEVIATION 0.3 |
| Region of Enrollment Malawi | 120 participants | 118 participants | 117 participants | 355 participants |
| Sex: Female, Male Female | 60 Participants | 53 Participants | 59 Participants | 172 Participants |
| Sex: Female, Male Male | 60 Participants | 65 Participants | 58 Participants | 183 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 117 | 0 / 120 | 0 / 118 |
| serious Total, serious adverse events | 0 / 117 | 0 / 120 | 0 / 118 |
Outcome results
Primary
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
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cow Pea Complementary Food | Change in Length-for-age z Score Over 6 Months From Enrollment to End of Study. | -0.14 z-score |
| Common Bean | Change in Length-for-age z Score Over 6 Months From Enrollment to End of Study. | -0.27 z-score |
| Corn Soy Flour | Change in Length-for-age z Score Over 6 Months From Enrollment to End of Study. | -0.27 z-score |
Primary
% 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
Time frame: 6 month
Secondary
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
Secondary
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
Secondary
Mid-upper Arm Circumference at 9 and 12 Months of Age
Mid-upper arm circumference in cm
Time frame: 6 months
Secondary
Weight-for-height z Score at 9 and 12 Months of Age
weight for height z-score at 9 and 12 months of age
Time frame: 6 months