Two clinical trials show no benefit of probiotics in kids with the stomach bugs

Acute gastroenteritis, commonly called the stomach flu, affects millions of children in the US every year causing diarrhea, vomiting, and abdominal pain. Gastroenteritis is usually caused by viruses, although not the flu virus contrary to popular thought, and it can last up to two weeks. No treatment is currently available for kids with stomach bugs and so people often turn to probiotics as a potential treatment option. Probiotics are live bacteria or microorganisms that are intended to provide health benefits when consumed by balancing the gut microbiome that is disrupted in disease. The global market for probiotics is currently valued at over $35 billion dollars and is expected to grow to $64 billion by 2023. Although probiotics are immensely popular as an at home remedy for a variety of ailments, there is a serious lack of rigorous clinical trials that support the health claims which prevents the proper regulations and information from getting to consumers. In two studies published in the New England Journal of Medicine (Schnadower D et al. and Freedman SB et al.), researchers have shown that two different formulations of commonly available probiotics have no added benefits for the treatment of gastroenteritis in children.

The first study conducted a randomized double-blind clinical trial (the gold standard in clinical trials) on 3 month to 4-year-old children presenting at the emergency department with gastroenteritis. A total of 943 participants completed the trial, 468 patients given the probiotic (Lactobacillus rhamnosus GG or Culturelle) and 475 patients given the placebo for 5 days after the diagnosis. The team found that 14 days after the initial diagnosis, there was no difference in the severity of the disease between the placebo or the probiotic. There was also no difference in the duration of diarrhea or vomiting in the children on either placebo or probiotic. There was also no difference in the number of days missed from daycare or the transmission of the virus to other family members. The conclusion of this first study was that 5-day treatment with Lactobacillus rhamnosus GG was no better than a placebo in treating the children.

In the second study, the team also conducted a randomized double-blind clinical trial on 3 to 48 month old children presenting to different emergency departments in Canada where they were randomized into either the placebo group or a treatment group with Lactobacillus rhamnosus R0011 and L. helveticus R0052 (commonly known as Lacidofil). There were a total of 210 patients enrolled with moderate-severe gastroenteritis, 108 given the probiotics and 102 given a placebo for 5-days. Once again, the team found no benefit in decreasing the duration of diarrhea, vomiting, or the frequency of visits to a doctor. The conclusion of the second study that there was no benefit of probiotics in the treatment of children with gastroenteritis compared to the placebo.

The take home message from these studies is that probiotics are not worth the money you spend on them for treating stomach bugs in children. You are better off spending your money on fresh fruits and veggies and making sure the children get plenty of fluids to replace what they are losing. This is a well-designed series of studies that uses double-blinding to ensure that no one knows which child is receiving which treatment.

Image Credit: Robson# – Flickr: Pills here, CC BY 2.0

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