Clinical trials: Environmental Enteric Dysfunction
Stunting of Growth, Chronic Malnutrition
Pilot Study of a Modified Therapeutic Food Compared With a Standard Nutrient Supplement in Young Children in Rural Guatemala
The goal of this clinical trial is to learn whether a modified food supplement is acceptable and well tolerated by children aged 12 to 24 months with mild-to-moderate stunting in rural Guatemala.
- Trial name
- NCT07804667
- Testing
- Modified Therapeutic Food Formulation, Nutri Listo SQ-LNS
- Where
- Guatemala
- Volunteers
- 36 people
- Sponsor
- Wuqu' Kawoq, Maya Health Alliance
Environmental Enteric Dysfunction
Glucagon-like Peptide 2 (GLP-2) in Undernourished Women Improving From Histology-Confirmed Environmental Enteric Dysfunction (EED)
The goal of this clinical trial is to learn whether teduglutide, a medicine that helps the intestine heal, can improve environmental enteric dysfunction in undernourished women aged 18 to 35 years living in urban slums of Dhaka.
- Trial name
- GAME (NCT07537686)
- Testing
- Teduglutide 0.05 dose
- Volunteers
- 55 people
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
Birth Outcomes, Stunting
Uganda Birth Cohort Study
The UBC was a USAID-funded longitudinal prospective cohort study of pregnant women (n= 5030) aged 15-49 years from rural North and South-Western regions of Uganda, conducted between 2014 and 2016.
- Conditions
- Birth Outcomes, Stunting, Wasting, Anemia
- Trial name
- UBC (NCT04233944)
- Where
- United States
- Volunteers
- 5,044 people
- Sponsor
- Tufts University
Environmental Enteric Dysfunction (EED)
Maternal Probiotic Intervention to Improve Gut Health - Trial II - Burkina Faso (MPIGH-II)
Burden: Environmental Enteric Dysfunction (EED) is an enteropathic condition characterized by altered gut permeability, infiltration of immune cells and changes in villous architecture and cell differentiation.
- Trial name
- MPIGH-II (NCT07134790)
- Testing
- VE818, Oral Vancomycin
- Where
- Burkina Faso
- Volunteers
- 144 people
- Sponsor
- University Ghent
Environmental Enteric Dysfunction
Lactoferrin and Lysozyme Supplementation for Environmental Enteric Dysfunction
Randomized, double-blind, placebo controlled trial of daily lactoferrin and lysozyme supplementation in improving environmental enteric dysfunction in Malawian children
- Trial name
- NCT02925026
- Testing
- Lactoferrin, Lysozyme
- Where
- Malawi
- Volunteers
- 235 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Environmental Enteric Dysfunction
Indispensable Amino Acids Bioavailability in Children With Environmental Enteropathy Dysfunction (IAA-EED)
In Morocco, large efforts have been made to enhance nutritional status and health conditions of children. Accordingly, stunting was reduced and the prevalence of stunting have decreased from 28,6% in 1987 to 14,9% in 2011.
- Trial name
- IAA-EED (NCT07256028)
- Testing
- Indispensable amino acids supplemntation, Without Indispensable amino acids supplementation
- Where
- Morocco
- Volunteers
- 40 people
- Sponsor
- Morocco's National Centre for Energy, Sciences and Nuclear Techniques
Rotavirus Infections, Environmental Enteric Dysfunction
SaniVac Trial - Sanitation and Oral Rotavirus Vaccine Performance
This is a controlled cohort study to assess the effect of improved sanitation on oral rotavirus vaccine performance in low-income urban neighbourhoods of Maputo, Mozambique.
- Conditions
- Rotavirus Infections, Environmental Enteric Dysfunction, Enteric Infections
- Trial name
- NCT03313128
- Testing
- Sanitation
- Where
- Mozambique
- Volunteers
- 261 people, healthy volunteers welcome
- Sponsor
- London School of Hygiene and Tropical Medicine
Enteropathy
The Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction in Rural Malawian Children 6-11 Months
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…
- Trial name
- NCT02472262
- Testing
- Cow pea complementary food, Corn soy flour, Common bean
- Where
- Malawi
- Volunteers
- 355 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Environmental Enteric Dysfunction (EED), Stunting
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Burden: Environmental Enteric Dysfunction (EED) is an enteropathic condition characterised by altered gut permeability, infiltration of immune cells, and changes in villous architecture and cell differentiation.
- Trial name
- MPIGH-II (NCT07207434)
- Testing
- Oral Vancomycin, VE818
- Where
- Pakistan
- Volunteers
- 144 people
- Sponsor
- Aga Khan University
Birth Weight, Pregnancy Preterm
Maternal EED and Aflatoxin Birth Outcomes Study Uganda
This prospective cohort study focuses on the relationship between maternal environmental enteric dysfunction (EED) and maternal aflatoxin B1 exposure and birth outcomes, particularly infant anthropometry and gestational age, in…
- Conditions
- Birth Weight, Pregnancy Preterm, Aflatoxins Toxicity, Inflammatory Response
- Trial name
- NCT03429257
- Testing
- Exposures of interest: Maternal EED and Aflatoxin Exposure
- Where
- Uganda
- Volunteers
- 258 people, healthy volunteers welcome
- Sponsor
- Tufts University
Stunting
Child Health, Agriculture and Integrated Nutrition
CHAIN is an open-label, individually randomized trial of improved infant and young child feeding (IYCF) versus "IYCF-plus" among 192 infants enrolled between 5-6 months of age in Shurugwi district, rural Zimbabwe.
- Trial name
- CHAIN (NCT04874688)
- Testing
- Small-quantity lipid-based nutrient supplement, Provitamin A biofortified maize, NUA-45 biofortified sugar beans
- Where
- Zimbabwe
- Volunteers
- 192 people
- Sponsor
- Queen Mary University of London
Stunting, Malnutrition; Protein
Protein Plus: Improving Infant Growth Through Diet and Enteric Health
This cluster-randomized controlled trial is designed to address linear growth faltering in 6-12-mo-old Bangladesh infants through a proof-of-concept package of interventions to a) increase intake of high quality protein and b)…
- Conditions
- Stunting, Malnutrition; Protein, Enteric Pathogens, Campylobacter Infections
- Trial name
- JiVitA-6 (NCT03683667)
- Testing
- Azithromycin Oral Product, Protein Supplement, Isocaloric Supplement
- Where
- Bangladesh
- Volunteers
- 5,283 people
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Environmental Enteric Dysfunction, Gut Microbiota Dysbiosis
Maternal Probiotic Intervention to Improve Gut Health
This trial will determine if a well-established probiotic, Vivomixx, can modulate maternal microbiota and ameliorate maternal environmental enteropathy which compromises growth in the first 1000 days.
- Trial name
- MPIGH (NCT06196450)
- Testing
- Vivomixx, Microcrystalline maltose
- Where
- Bangladesh
- Volunteers
- 76 people
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
Malnutrition, Environmental Enteropathy
Intervention and Mechanisms of Alanyl-Glutamine for Inflammation, Nutrition, and Enteropathy
Several host factors underlie the pathogenesis of the reciprocal cycle of childhood diarrhea and undernutrition in developing countries.
- Conditions
- Malnutrition, Environmental Enteropathy, Diarrhea
- Trial name
- IMAGINE (NCT01832636)
- Testing
- Alanyl-Glutamine
- Where
- Brazil
- Volunteers
- 112 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Amino Acid, Stunting, Environmental Enteric Dysfunction
The Efficacy of Amino Acid Supplementation in Treating Environmental Enteric Dysfunction Among Children At Risk of Malnutrition
A randomised controlled open label clinical trial to determine whether addition of indispensable amino acids (IAA) to standard complementary food will reduce occurrence of Environmental Enteric Dysfunction (EED) compared with…
- Trial name
- NCT06617130
- Testing
- Corn soy bean blended flour porridge plus indispensable amino acid
- Where
- Malawi
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Kamuzu University of Health Sciences
Malnutrition, Infection
The Bangladesh Environmental Enteric Dysfunction Study
This is a community-based intervention study which will be undertaken at Mirpur, Dhaka, Bangladesh. Participants will be recruited from two age groups: a child cohort (age 12 to 18 months) and an adult cohort (age 18 to 45…
- Trial name
- BEED (NCT02812615)
- Testing
- Egg, Milk, Albendazole/Pyrantel Pamoate
- Where
- Bangladesh
- Volunteers
- 1,575 people
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
Environmental Enteric Dysfunction, Zinc Deficiency
Effects of EED on Zn Absorption and Retention in Children From a Standard Dose
The overall objective is to determine the impact of EED on zinc absorption and homeostasis, and its impact on the absorptive capacity of vitamin A absorption of young children (18-24 months of age) in an austere setting with high…
- Conditions
- Environmental Enteric Dysfunction, Zinc Deficiency, Vitamin A Deficiency
- Trial name
- ZEED1 (NCT02760095)
- Testing
- 3 mg zinc sulfate supplement, 0.5 mg of 13C10-retinyl-acetate
- Where
- 2 sites in United States, Bangladesh
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Malnutrition Pregnancy, Malnutrition in Children
Early Life Malnutrition, Environmental Enteric Dysfunction and Microbiome Trajectories
Malnutrition in women of reproductive age remains a public health concern in Sub-Saharan Africa (SSA). Malnutrition during pregnancy affects foetal growth with a tendency of the exposed infants to also develop it.
- Conditions
- Malnutrition Pregnancy, Malnutrition in Children, Malnutrition (Calorie), Environmental Enteric Dysfunction
- Trial name
- UZBCS-2 (NCT07195006)
- Testing
- Malnutrition in pregnancy as exposure, Poor WASH living conditions as exposure
- Where
- Zimbabwe
- Volunteers
- 368 people, healthy volunteers welcome
- Sponsor
- University of Zimbabwe
Environmental Enteric Dysfunction
Probiotic For the Improvement of Environmental Enteropathy in Pregnant Women in Senegal
Stunting in young children refers to attenuated linear growth. In the year 2020, 149.2 million children under the age of 5 were stunted, accounting for 22% of stunting globally.
- Trial name
- PROFE-Sen (NCT05501470)
- Testing
- Probiotic, CapScan®
- Where
- Senegal
- Volunteers
- 76 people
- Sponsor
- Institut Pasteur de Dakar
Environmental Enteric Dysfunction
Maternal Probiotic Intervention to Improve Gut Health - Trial II - Bangladesh
Burden: Environmental Enteric Dysfunction (EED) is an enteropathic condition characterised by altered gut permeability, infiltration of immune cells and changes in villous architecture and cell differentiation.
- Trial name
- MPIGH-II (NCT06817031)
- Testing
- VE818, Oral Vancomycin
- Where
- Bangladesh
- Volunteers
- 144 people
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh