Study of Environmental Enteropathy and Malnutrition in Pakistan
Condition: Malnutrition, Child; Enteropathy; Vaccine Response Impaired; Stunting; Gastrointestinal Disease
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Malnutrition; Child Nutrition Disorders
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): Nutritional education; Ready to Use Therapeutic Food; Upper gastrointestinal endoscopy with biopsy
Intervention type(s): Other; Dietary Supplement; Procedure
Intervention description(s): 4 week home delivered educational program that will focus on breast feeding and complimentary feeding. If child remains WHZ < -2 at by 9 months of age families will be shown 10 minute educational video detailing best practices for complimentary feeding.; If child remains WHZ < -2 despite nutritional education then will be managed according to Pakistan's Community Management of Acute Malnutrition protocol. This will include provision of ready to use therapeutic food (RUTF) to the child at home with close follow up. Utilization of the RUTF will be monitored closely by bi-weekly home visits.; If child remains at WHZ < -2 despite educational and dietary interventions, then will undergo medical evaluation for assessment of need for more advanced workup of malnutrition, including UGI endoscopy at AKUH. Results of the advanced work up, including the UGI endoscopy, will guide future management of these children.
Other intervention name(s): Education; RUTF; UGI endoscopy; Biopsy; Esophagoduodenoscopy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Moderately or severely malnourished (weight for height Z score (WHZ) < -2) children
Well-nourished (WHZ > 0) children
Control group of children in the US with celiac disease
Control group of children in the US with Crohn's disease
Control group of healthy age-matched children in the US
Masking: None (Open Label)
Primary purpose: Prevention