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Challenges associated with a stable isotope based sucrose breath test for environmental enteric dysfunction assessment in a rural Kenyan setting in the context of COVID-19 pandemic
Abstract
Background: Researchers conducting clinical studies involving stable isotopes face technical and logistical challenges. They seldom discuss them in publications, yet they have serious ramifications on data quality and usability.
Objective: To document methodological and technical challenges encountered during implementation of a stable isotope-based sucrose breath test study to assess the relationship between environmental enteric dysfunction and linear growth among children aged 12-15 months in resource limited setting in Siaya County, Western Kenya.
Methods: The study adopted cross-sectional analytical design. Included 100 mother-children pair aged 12-15 months. The Carbon13C dioxide (13CO2) recovery following an oral dose of 13Carbon-sucrose sugar was determined for assessment of environmental enteric dysfunction.
Results: Key challenges included delayed ethical and logistical approvals, COVID19 pandemic, tardy study implementation, and revised protocol to minimize stay time. Furthermore, higher cost of supplies, difficulties in recruitment, spillage of the sugar solutions, dearth of local capacity to analyze the breath, local consumption of 4-carbon compound(C4) plant-based diets like sugar cane and Maize, with higher 13 C enrichment and high loss to follow up.
Conclusion: Uncertainties like COVID-19 pandemic present critical challenges, requiring novel preparedness plans. Adequate consenting addresses myths and misconceptions. Further enrichment of the 13Carbon-sucrose sugar to overcome challenge of C4 plant-based diets. Building local and regional analytical laboratory capacities to address the logistical and analysis hitches of breath samples.