Probiotics are often suggested to children with stomach viruses to ease symptoms of diarrhea and vomiting. But a new study published in the New England Journal of Medicine demonstrates that probiotics are not effective in the recovery of young patients with gastroenteritis compared to placebo.
Acute infectious gastroenteritis in children remains a major public health issue, particularly in low-income countries, where this condition accounts for substantial neonatal mortality.
The study provides evidence against the popular and costly use of probiotics — live microorganisms believed to restore the balance of intestinal bacteria and boost the immune system.
David Schnadower, professor of Pediatrics, Washington University, and colleagues conducted this prospective, randomized, double-blind trial to determine whether probiotics are effective for the treatment of acute gastroenteritis in children.
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“Probiotics have become an increasingly popular way to treat children experiencing acute gastroenteritis,” saidSchnadower. “Some smaller studies have indicated that probiotics may help, however, such studies had a number of limitations. We sought to provide independent and conclusive evidence for or against probiotic use in infants and toddlers with acute gastroenteritis.”
The U.S. study involved 971 children treated between July 2014 and June 2017 in the emergency departments at St. Louis Children’s and nine other geographically diverse U.S. academic medical centers. Participants were eligible if they had come to the emergency room with symptoms of gastroenteritis: watery stools, vomiting, diarrhea or other signs of acute intestinal infection. They also had to have not have taken probiotics in the preceding two weeks.
The researchers evaluated a common probiotic known as Lactobacillus rhamnosus GG, or LGG, which is sold over the counter as Culturelle. Certain versions of the probiotic are intended for babies and children.
Half of the children in the study were randomly assigned to receive the probiotic Lactobacillus rhamnosus GG twice daily for five days, while the others took a similarly looking and tasting placebo. Otherwise, the children received standard clinical care. Neither the researchers nor the parents knew which children had received the probiotics.
- The modified Vesikari scale score for the 14-day period after enrollment was 9 or higher in 55 of 468 participants (11.8%) in the L. rhamnosus GG group and in 60 of 475 participants (12.6%) in the placebo group.
- There were no significant differences between the L. rhamnosus GG group and the placebo group in the duration of diarrhea (median, 49.7 hours in the L. rhamnosus GG group and 50.9 hours in the placebo group; P=0.26), duration of vomiting (median, 0 hours in both groups; P=0.17), or day-care absenteeism (median, 2 days in both groups; P=0.67) or in the rate of household transmission (10.6% and 14.1% in the two groups, respectively; P=0.16).
There are no treatments for pediatric acute gastroenteritis other than giving children fluids to prevent dehydration and, sometimes, medication to relieve nausea. The lack of options has prompted some physicians and parents to give ill children probiotics.
Probiotics generally are considered safe. However, the Food and Drug Administration (FDA) does not regulate dietary supplements such as probiotics as stringently as it does prescription and over-the-counter drugs. “Also, manufacturers of probiotics generally can claim that these microorganisms have positive health benefits without rigorous evidence to support their use,” Schnadower said.
“Because of the popularity of probiotics, it was important to make sure their use is worth the cost,” said Schnadower. “In this instance, probiotics added no measurable benefit, and, therefore, they are not worth the added cost.”
Regardless of whether the children took a placebo or probiotic, their symptoms and recovery were nearly identical. The data showed that diarrhea in both groups of kids lasted about two days and the kids missed an average of two days of daycare.
“We tested many different scenarios — infants compared with toddlers, whether the patient had taken antibiotics, whether the gastroenteritis was caused by virus or bacteria, and how long the diarrhea had been going on before the treatment was given. We also had the probiotic independently tested for purity and strength. Every time, we reached the same conclusion,” Schnadower said. “LGG did not help.”
For further reference log on to 10.1056/NEJMoa1802598