Study of Environmental Enteropathy and Malnutrition in Pakistan

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.

Conditions

• Stunting
• Gastrointestinal Disease
• Malnutrition, Child
• Enteropathy
• Vaccine Response Impaired

Interventions

OTHER

Nutritional education

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.

DIETARY_SUPPLEMENT

Ready to Use Therapeutic Food

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.

PROCEDURE

Upper gastrointestinal endoscopy with biopsy

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.

Sponsors & Collaborators

• University of Virginia

  collaborator OTHER

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• Aga Khan University

  lead OTHER

Principal Investigators

• Syed Asad Ali, MD, MPH · Aga Khan University

• Sean R Moore, MD · University of Virginia

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

0 Days

Max Age

10 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-03-01

Primary Completion

2019-07-31

Completion

2019-07-31

Countries

• Pakistan

Study Locations