Environmental EnteropathyNCT02472301
The Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction in Rural Malawian Children 1-3 Year Olds
A study testing cowpeas complementary food, corn-soy flour and common bean complementary food in people with Environmental Enteropathy, run by Washington University School of Medicine at 1 site in Malawi.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Environmental Enteropathy
- What is being tested?
- cowpeas complementary food, corn-soy flour and common bean complementary food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 337 participants
- Where
- 1 siteMalawi
- Study dates
- Aug 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 35 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Environmental Enteropathy
- Being tested
- cowpeas complementary food, corn-soy flour, common bean complementary food
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cowpeas complementary foodDietary supplement
cowpeas supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
corn-soy flourDietary supplement
Corn-soy flour supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
common bean complementary foodDietary supplement
common bean supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Cowpeas | Experimental | Cowpea supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months. Receives: Dietary Supplement: cowpeas complementary food |
| Common bean | Experimental | Common bean supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months. Receives: Dietary Supplement: common bean complementary food |
| Corn Soy Flour | Active comparator | Corn flour with 10% soy supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months. Receives: Dietary Supplement: corn-soy flour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual Sugar Absorption Test
lactulose-mannitol ratio in urine
Measured: 3 months
Dual Sugar Absorption Test
lactulose-mannitol ratio in urine
Measured: 6 months
Dual Sugar Absorption Test
lactulose-mannitol ratio in urine
Measured: 12 months
Secondary outcomes (6)
Lactulose Excretion
percentage of ingested lactulose excreted in urine
Measured: 3 months
Lactulose Excretion
percentage of ingested lactulose excreted in urine
Measured: 6 months
Lactulose Excretion
percentage of ingested lactulose excreted in urine
Measured: 12 months
Mannitol Excretion
percentage of ingested mannitol excreted in urine
Measured: 3 months
Mannitol Excretion
percentage of ingested mannitol excreted in urine
Measured: 6 months
Mannitol Excretion
percentage of ingested mannitol excreted in urine
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Environmental EnteropathyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Manary, MD, Principal investigator, Washington University School of Medince
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02472301
- Sponsor's protocol ID
- LG2
- Status last verified
- May 2017
- First submitted
- 9 Jun 2015
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31022095Borresen 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.
PubMed 29955682Agapova 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.
PubMed 29490090Trehan 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.
PubMed 26578308
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02472301
- Acronym / sponsor ID
- LG2
- Conditions
- Environmental Enteropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 15 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cowpeas | Experimental | Dietary Supplement: cowpeas complementary foodCowpea supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months. |
| Common bean | Experimental | Dietary Supplement: common bean complementary foodCommon bean supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months. |
| Corn Soy Flour | Active comparator | Dietary Supplement: corn-soy flourCorn flour with 10% soy supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months. |
Who may qualify
- Ages
- 12 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cowpeas complementary foodcowpeas supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months. | Dietary supplement | Cowpeas |
| corn-soy flourCorn-soy flour supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months. | Dietary supplement | Corn Soy Flour |
| common bean complementary foodcommon bean supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months. | Dietary supplement | Common bean |
Primary outcome
Dual Sugar Absorption Test
Time frame: 3 months
lactulose-mannitol ratio in urine
Dual Sugar Absorption Test
Time frame: 6 months
lactulose-mannitol ratio in urine
Dual Sugar Absorption Test
Time frame: 12 months
lactulose-mannitol ratio in urine
6 secondary outcomes
Lactulose Excretion
Time frame: 3 months
Lactulose Excretion
Time frame: 6 months
Lactulose Excretion
Time frame: 12 months
Mannitol Excretion
Time frame: 3 months
Mannitol Excretion
Time frame: 6 months
Mannitol Excretion
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Derived from this study: PubMed 31022095Kaimila 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.
- Derived from this study: PubMed 29955682Borresen 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.
- Derived from this study: PubMed 29490090Agapova 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.
- Derived from this study: PubMed 26578308Trehan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Manary, MD principal investigator
Washington University School of Medince
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cowpeas complementary food, corn-soy flour and common bean complementary food in people with Environmental Enteropathy, run by Washington University School of Medicine at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual Sugar Absorption Test (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02472301, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.