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PATH’s Drug Development program has launched a phase 2 clinical trial in Bangladesh to test a new formulation of oral rehydration solution (ORS), a therapy that is being evaluated for reversing dehydration that results from severe diarrhea caused by diarrheal disease. The three-part trial, conducted in partnership with the International Centre for Diarrhoeal Disease Research, Bangladesh, will evaluate three new starch-based formulations of ORS, comparing them with current glucose-based treatment and selecting the most promising option for further development and commercialization.

ORS was introduced in the 1970s as a simple, inexpensive, and highly effective means to reverse dehydration. It quickly became a cornerstone of international programs for the control of diarrheal disease, especially in resource-limited countries, resulting in a marked decrease in illness and death. Yet over the last decade, adequate use of ORS has decreased, partly because while it can save lives, it does not reduce the severity or duration of diarrhea. As a result, its effect is not readily seen by patients or their caregivers, who may not be motivated to comply with treatment.

Together with partners, PATH is working to address the shortcomings of ORS by exploring changes to the standard formulation with an added treatment agent, such as fermentable starch that is differentially broken down along the digestive tract. This promotes fluid and electrolyte absorption in the intestine, reducing diarrheal symptoms and motivating patients to comply with treatment.

The current trial, which builds upon the results of a preliminary clinical trial in India, will determine whether fermentable starch formulation effectively reduces diarrheal symptoms and reverses dehydration. The first patient enrolled on April 11. The trial is expected to take approximately 18 months and enroll 150 patients.

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Posted May 6, 2013.