Diarrhea is a common problem for infants and young children. Now a new type of treatment called fORT is being tested to determine if it reduces the severity and duration of the illness and also save money.
Diarrhea is a way for the body to get rid of viruses, bacteria, or worms that have invaded it. It literally “flushes out the infection,” said Dr. Paul Breslin, a professor of nutritional sciences at Rutgers University.
For years, doctors have treated the ailment with ORT, an oral rehydration therapy that has helped prevent the deaths of millions of children worldwide due to diarrhea. Yet while it is able to prevent dehydration, ORT does not address the cause of the illness. There is no standard treatment to reduce the severity and duration of diarrhea, Dr. Breslin said.
His study is testing a new kind of remedy called fORT, an amino acid-fortified oral rehydration therapy. The study will measure how much and how long the diarrhea lasts after taking fORT, and if the fORT doses help children gain back weight compared to traditional ORT.
Recent studies in adults and in mice suggest that an ORT formula fortified with multiple amino acids may resolve diarrhea more rapidly than standard ORT, Dr. Breslin said.
The fORT formula will contain five amino acids – glutamate/glutamine and the three branched chain amino acids valine, leucine, and isoleucine.
“These amino acids we believe will help children’s bodies fight severe diarrhea by providing the nutrients their gut needs and may help kill infection-causing germs,” Dr. Breslin said. He thinks the amino acids will help the children’s natural immune response work against common intestinal bugs like norovirus or Shigella, and even SARS-CoV-2 and its many variants.
“We are really targeting the root causes of the diarrhea,” he explained, while at the same time helping children become hydrated faster.
Worldwide, diarrhea is the second leading cause of death in children under 5 years of age and costs more than $5 billion annually to treat in the US.
Dr. Breslin’s team, which includes graduate student Payment Harmon, clinicians and formulations experts at Rutgers University, and one of the pioneers of ORT from Yale University, Dr. Henry Binder, plans to study 72 young children, aged 6 to 36 months and equally divided between control and treatment groups. Patients will be enrolled at discharge from the hospital emergency room.
Parents and caretakers will be provided powdered packets of ORT and fORT, which will be mixed with clean water into one liter, marked bottles. Parents will maintain daily logs of the liquid intake, and the weight, number and amount of stools. Stool samples will be collected daily.
Because the mix of amino acids are classified as a “medical food,” by the federal Food and Drug Administration, it eliminates the need for several stages of clinical trials that drugs must adhere to, Dr. Breslin noted. “All of the ingredients in fORT are found in food products,” he said.
If the Gerber Foundation-funded study proves effective, Dr. Breslin will initiate a full clinical trial with infants and young children with more severe disease.
Ultimately, fORT could prove to be a cheap, effective, and easily distributed treatment for diarrhea in children both in the U.S. and worldwide.
“fORT could help reduce the severity or duration of the disease, which would especially improve the lives of children in countries where diarrhea can be deadly, Dr. Breslin said. “Our ultimate goal is to have an inexpensive, easily distributed, shelf-stable, and effective diarrhea treatment.”
He also extended his thanks to the Gerber Foundation. “We deeply appreciate the attention to our work and the faith in us and our ideas as we go forward,” he said.
Dr. Breslin’s team includes Payton Harmon, Drs. Sally Radovick, Melisa Weidner, Prerna Trivedy, Elizabeth George, Sunanda Guar, Julie Elmer, Nolan Lewin, and Henry Binder.
