Jim Kling

October 23, 2014

SAN DIEGO — When an extract from tea leaves and pomegranate (LifeDrops, LiveLeaf) is combined with a standard oral rehydration solution, children with diarrhea improved faster, according to a new study.

"If this were widely available in village grocery stores, it could save a lot of lives and it could save a lot of trips to clinics," Arthur Dover, MD, head of the Dover Travel Clinic in Aptos, California, told Medscape Medical News.

The product consists of polyphenols extracted from green tea and pomegranate, which have been stabilized to prevent degradation in the intestine. Once there, they stimulate the immune defense system, explained Dr Dover, who presented the research here at the American Academy of Pediatrics 2014 National Conference and Exhibition.

A previous study conducted in Bangladesh demonstrated the safety of the product, but not its efficacy, likely because many of the subjects had cholera, which is difficult to treat, explained Dr Dover.

The current study was conducted in a community clinic in Nicaragua, and patients had uncontrolled diarrhea in the previous 48 hours. The research was performed in the aftermath of a hurricane, and the diarrhea was likely related to Escherichia coli in contaminated water supplies.

The 61 children, 2 to 17 years of age, received an oral rehydration solution for 2 days. In addition, 30 patients received the extract on day 1, and 31 received the extract on day 2 and served as the control group.

The researchers observed the patients in the first 24 hours after consumption of the fluids, and rated each bowel movement on the Bristol Stool Scale (BSS).

The average time to achieve a BSS score of 4 or less was significantly shorter in the extract group than in the control group (3.1 vs 9.2 hours; P = .002).

In addition, a BSS score of 4 or less in the first bowel movement after treatment was achieved by more patients in the extract group than the control group (60% vs 29%). BSS scores in the extract group were maintained on day 2.

Patients in the control group achieved a BSS score of 4 or less within 24 hours of receiving the combination. On day 1, the average number of 4 bowel movements was 4, and on day 2 it was 2 (P = .0001).

The researchers reported no adverse events in either group.

Viral vs Bacterial Infection

The work is promising, but questions remain about safety, especially in children with bacterial disease that involves a toxin, said Lauren Herbert, MD, a pediatrician and pediatric infectious diseases specialist at Peace Health in Springfield, Oregon, who attended the session.

"An over-the-counter product would be used by parents in both settings. In viral gastroenteritis it might be okay, but I'm not sure it would be safe with bacterial gastroenteritis," she told Medscape Medical News.

Dr Herbert said she worries about increasing the risk for hemolytic uremic syndrome in E coli infections, or invasive infections in diseases like Salmonella. "I'd want to be sure it's safe and effective in bacterial gastroenteritis, because that's where I'm concerned you'd end up having some complications," she said.

Dr Dover said he believes that the product will be safe in bacterial cases. "We showed in Bangladesh that there is no problem with bacterial gastroenteritis. There was Shigella, E coli, Salmonella...and there was no problem," he reported.

Next, the researchers plan to assess the potential cost savings of the product, including its economic impact, because diarrheal diseases can impose a heavy financial burden. Dr Dover said he hopes that if a substantial economic impact can be shown, charities like the Bill & Melinda Gates Foundation might be interested in helping to underwrite the product.

The study was funded by LiveLeaf, which markets LifeDrops. Dr Dover reports receiving travel support from the company. Dr Herbert has disclosed no relevant financial relationships.

American Academy of Pediatrics (AAP) 2014 National Conference and Exhibition: Abstract 24051. Presented October 12, 2014.

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