NCT03588013: SEEM

Study of Environmental Enteropathy and Malnutrition in Pakistan

Completed NA Last updated 8 September 2021

What this trial tests

NA trial testing Nutritional education in Malnutrition, Child in 416 participants. Completed in 31 July 2019.

Timeline

1 March 2016

Primary endpoint
31 July 2019

31 July 2019

Quick facts

Lead sponsor	Aga Khan University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	416
Start date	1 March 2016
Primary completion	31 July 2019
Estimated completion	31 July 2019
Sites	1 location across Pakistan

Drugs / interventions tested

• Nutritional education
• Ready to Use Therapeutic Food
• Upper gastrointestinal endoscopy with biopsy

Conditions studied

• Malnutrition, Child — all drugs for Malnutrition, Child →
• Enteropathy — all drugs for Enteropathy →
• Vaccine Response Impaired — all drugs for Vaccine Response Impaired →
• Stunting — all drugs for Stunting →

Sponsor

Aga Khan University

Who can join

Adults 0 Days to 10, any sex, with Malnutrition, Child or Enteropathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Environmental Enteropathy (EE) is an acquired sub-clinical inflammatory gut condition in which alterations in intestinal structure, function, and local and systemic immune activation lead to impaired vaccine responses, decreased cognitive potential and undernutrition in low-middle income countries. Approximately half of all global deaths in children aged less than five years are attributable to undernutrition making the study of EE an area of critical priority. However, given the operational limitations and ethical considerations for safely obtaining intestinal biopsies from young children in low resource settings, there have been few detailed investigations of human intestinal tissue in this vulnerable patient group for whom reversal of EE would provide the greatest benefit. EE biomarkers have been studied in different settings but these have not been correlated with the gold standard histopathology confirmation. The Study of Environment Enteropathy and Malnutrition in Pakistan (SEEM Pakistan) is designed to better understand the pathophysiology, predictors, biomarkers, and potential management strategies of EE to inform strategies to eradicate this debilitating pathology.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mucosal Genomics Implicate Lymphocyte Activation and Lipid Metabolism in Refractory Environmental Enteric Dysfunction.
   Haberman Y, Iqbal NT, Ghandikota S, Mallawaarachchi I, et al · · 2021 · cited 59× · PMID 33524399 · DOI 10.1053/j.gastro.2021.01.221
2. Study of Environmental Enteropathy and Malnutrition (SEEM) in Pakistan: protocols for biopsy based biomarker discovery and validation.
   Iqbal NT, Syed S, Sadiq K, Khan MN, et al · · 2019 · cited 27× · PMID 31331393 · DOI 10.1186/s12887-019-1564-x
3. Bile Acid Profiling Reveals Distinct Signatures in Undernourished Children with Environmental Enteric Dysfunction.
   Zhao X, Setchell KDR, Huang R, Mallawaarachchi I, et al · · 2021 · cited 25× · PMID 34718665 · DOI 10.1093/jn/nxab321
4. Association of Anti-Rotavirus IgA Seroconversion with Growth, Environmental Enteric Dysfunction and Enteropathogens in Rural Pakistani Infants.
   Ahmed S, Iqbal J, Sadiq K, Umrani F, et al · · 2022 · cited 10× · PMID 35534310 · DOI 10.1016/j.vaccine.2022.04.032
5. Essential Fatty Acid Deficiency Associates with Growth Faltering and Environmental Enteric Dysfunction in Children.
   Narvaez-Rivas M, Setchell KDR, Galandi SL, Zhao X, et al · · 2023 · cited 4× · PMID 37110148 · DOI 10.3390/metabo13040489
6. Nutrient dataset development via FAO/INFOODS approach for infant nutritional survey in rural Matiari, Pakistan.
   Soomro SI, Jamil Z, Memon N, Ahmed S, et al · · 2024 · cited 2× · PMID 39221176 · DOI 10.1016/j.jfca.2024.106471
7. Host-microbiome determinants of ready-to-use supplemental food efficacy in acute childhood malnutrition.
   Jamil Z, Hanson GF, Iqbal J, Moreau GB, et al · · 2025 · cited 1× · PMID 40693466 · DOI 10.1172/jci.insight.188993
8. Fatty Acid Profile, Lipid Quality Indices and Oxidative Stability of Snacks Consumed by Children Aged 6-24 Months in Rural Matiari, Sindh, Pakistan.
   Chohan S, Soomro SI, Mahesar SA, Ahmed S, et al · · 2025 · PMID 41097472 · DOI 10.3390/foods14193302