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Sifting through health claims, facts about probiotics
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Defined as “live microorganisms that, when administered in adequate amounts, confer a health benefit on the host,” probiotics have been studied for uses in pediatrics for many years. Parents themselves are no strangers to probiotic products, as many have independently administered probiotics — particularly yogurt — to their children for the treatment of mild gastrointestinal conditions.
Results of the National Health Interview survey conducted in 2007 and 2012 on complementary health approaches among children aged 4 to 17 years (n = 17,321) indicated that probiotics were among the top 3 non-vitamin/non-mineral dietary supplements used.
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Probiotic products are widely available and differ significantly, by specific microbial species and number of microorganisms; a glance at the probiotic section in the local pharmacy or health food store will highlight the wide array of products, some containing 5 to 10 (or more) different microbial species in varying amounts.
However, consumers should pay special attention to the specific microbial species and the number of organisms — often expressed as colony forming units (CFU) — contained in the product as prior studies have demonstrated that not all microbial species produce equal clinical benefits.
Further, it is also important for parents and caregivers to consider that since probiotic products are categorized as dietary supplements, they are subject to significantly less stringent regulatory oversight for efficacy and safety claims compared with over-the-counter or prescription drug products.
Recent literature reviews of probiotic studies in the pediatric population have provided evidence to support their use for the treatment of acute gastroenteritis, antibiotic-associated diarrhea and nosocomial diarrhea, as well as severe necrotizing enterocolitis among preterm infants. Although probiotics have been studied for other conditions, such as ulcerative colitis, colic, allergy prevention and Helicobacter pylori infection, the lower quality of evidence limits widespread clinical applicability.
Treatment of acute gastroenteritis
In a recent position paper, the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) provided recommendations for the use of probiotics for acute gastroenteritis based on a systematic review of randomized controlled trials. Of the various probiotic species evaluated in these trials, the most commonly studied were Lactobacillus rhamnosus GG (LGG) and the yeast Saccharomyces boulardii.
Although the collective quality of evidence from these trials was deemed to be low — due to trial methodological limitations, such as a lack of or unclear blinding — the working group gave a “strong” recommendation for the use of LGG or S. boulardii to effectively treat acute gastroenteritis in children.
A strong recommendation was described by the authors as “the evidence showed that the benefit of the intervention clearly outweighs the undesirable effects.” Clinical benefits of these two probiotic species included a reduction in the duration of diarrhea by approximately 1 day and a risk reduction in diarrhea lasting 4 days or more. Doses of LGG greater than 10 billion CFUs daily were demonstrated in several trials to be more effective than lower doses. More than 25 other probiotic species were evaluated by ESPGHAN, and were found to have insufficient evidence for effective and safe use.
Prevention of antibiotic-associated diarrhea
A more recent analysis by ESPGHAN, using similar literature review methods, described the use of probiotics for the prevention of antibiotic-associated diarrhea. Twenty-one controlled trials of more than 3,000 children were systematically evaluated, demonstrating that probiotics reduced the risk for antibiotic-associated diarrhea by 52%. Specific probiotics with the most supportive evidence were LGG and S. boulardii (moderate quality of evidence and a strong recommendation). Fewer data from controlled trials are available for the prevention of diarrhea due to Clostridium difficile. For this use, ESPGHAN “conditionally” recommends using S. boulardii.
Data from these reviewed trials indicate that daily doses of 10 billion to 20 billion CFUs for LGG and 250 mg (5 billion CFUs) for S. boulardii are most likely to be effective. Other probiotic microbial species evaluated in the review were deemed to have too few supportive efficacy data to support their clinical use. A similar literature review by Johnston and colleagues published in late 2016 also found the most supportive evidence for LGG or S. boulardii to prevent antibiotic-associated diarrhea.
Probiotics may provide additional clinical benefits to infants and children, although they are not as well supported by published trials. Recent literature reviews for these uses have been published. Some evidence suggests that probiotics may provide benefit for the reduction of community-acquired infections, reduction of infantile colic, and risk reduction of eczema.
Additional data from controlled trials are needed for these uses however, and the most effective probiotic species have not been determined. The latest AAP report on probiotics, from 2010, describes modest benefits from probiotics for the treatment of acute gastroenteritis and prevention of antibiotic-associated diarrhea.
Product selection and considerations
When recommending a probiotic for a specific infant or child, it is important to have an appreciation for the differences in the available probiotic products. Recommendations given to a parent to use a probiotic for a specific purpose may lead the parent to purchase any number of different products, containing widely varying microbial species in differing or unknown amounts.
As previous studies have demonstrated, clinical benefits are specific to microbial species and number of organisms (dose). Most clinically beneficial evidence exists for LGG and S. boulardii when used to treat acute gastroenteritis or prevent antibiotic-associated diarrhea. Other probiotic species may provide little or no benefit for these uses. As clinical benefits are likely to be species-specific and dose-specific, it has been recommended to use the specific probiotic as evaluated in controlled trials for a specific use.
The table lists two probiotic products that may be reasonable to recommend to parents, as these products contain the probiotic species with the most supportive evidence from clinical trials. Other probiotic products that do not contain these species, even if advertised as containing “many probiotic strains” may not provide the desired benefits. Yogurt is often touted as a useful probiotic food source and potentially effective for the treatment of a variety of conditions.
A recent literature review of yogurt for the prevention of antibiotic-associated diarrhea evaluated two controlled trials of low methodological quality, demonstrating no benefit from yogurt consumption. Yogurt may not contain an adequate number of probiotic species to demonstrate efficacy when given as commonly available single-use food products.
Probiotics have been evaluated for a variety of uses. Most of these uses, although promising, currently do not have sufficient supportive evidence from well done controlled trials. There are more data to support probiotic use in select otherwise healthy children for the treatment of acute gastroenteritis (supplemental to rehydration) and for the prevention of antibiotic-associated diarrhea.
However, as most probiotic products contain live microorganisms, they are best not given to infants and children with immunocompromising conditions, seriously ill children or children with indwelling catheters. Case reports of serious adverse effects, including death, from probiotic use in these conditions have been reported. Probiotics should not be thought of as a homogenous group, “probiotics,” and are best recommended as a specific microbial species, and dosed accordingly. The most evidence for clinical benefits exists for LGG and S. boulardii.
- References:
- Black LI, et al. Natl Health Stat Report. 2015;78:1-18.
- Johnston BC, et al. JAMA. 2016;doi:10.1001/jama.2016.11838.
- Patro-Golab B, et al. Nutrition. 2015;doi:10.1016/j.nut.2014.11.013.
- Szajewska H, et al. J Pediatr Gastroenterol Nutr. 2014;doi:10.1097/MPG.0000000000000320.
- Szajewska H, et al. J Pediatr Gastroenterol Nutr. 2016;doi:10.1097/MPG.0000000000001081.
- Szajewska H. Arch Dis Child. 2016;doi:10.1136/archdischild-2015-308656.
- Thomas DW. Pediatrics. 2010;doi:10.1542/peds.2010-2548.
- For more information:
- Edward A. Bell, PharmD, BCPS, is a professor of pharmacy practice at Drake University College of Pharmacy and Health Sciences and Blank Children’s Hospital and Clinics, Des Moines, Iowa. He also is a member of the Infectious Diseases in Children Editorial Board. Bell can be reached at ed.bell@drake.edu.
Disclosure: Bell reports no relevant financial disclosures.