June 13, 2006 -- A drug called Alinia (nitazoxanide) may shorten the course of severe in children, according to a new study.
The study looked at 38 children aged 5 months to 7 years (average age: 11 months) hospitalized in Cairo, Egypt. It found that the children's severe, watery diarrhea ended sooner with Alinia than with a placebo lacking Alinia's active ingredient.
The children's diarrhea was due to rotavirus, the world's leading cause of severe diarrhea in children, write the researchers
The study appears online in The Lancet and was done by a group that included Jean-Francois Rossignol, MD, of the pediatric gastroenterology department at Egypt's University of Cairo Children's Hospital.
The researchers conducted the study while the children were hospitalized, with the parents' permission.
For three days, Rossignol's team gave half the children twice-daily oral doses of Alinia. They gave the rest a placebo. All also received routine care, including rehydration to replace water loss from their diarrhea.
The kids stayed in the hospital at least four more days after the treatment. They also got another checkup two weeks after their first treatment.
On average, it took 31 hours for the diarrhea to resolve in the Alinia group, compared with 75 hours for the placebo group, the study shows.
Treating Rotavirus in Kids
Every year, rotavirus leads to an estimated 500,000 deaths worldwide, mostly in developing countries that may lack medical resources and safe drinking water, which is needed to rehydrate diarrhea patients, Rossignol's team notes.
It also leads to hospitalization for diarrhea of about one in 40 children under the age of 5 in developed countries each year, the researchers note.
Most of the patients in Rossignol's study were also malnourished, the study notes.
The FDA approved a rotavirus vaccine in February and another rotavirus vaccine is in the works. Even so, "there remains a need for an effective treatment for rotavirus infection when it does occur," write Rossignol and colleagues.
They note that "although the number of patients enrolled was small, we found no adverse experiences associated with the use of nitazoxanide."
Larger studies are underway to confirm this study's results.
"In the interim, the results reported here are encouraging and might lead us to think about new approaches to managing rotavirus disease in children," write Rossignol and colleagues.
The study was funded by Alinia's maker, Romark Laboratories.