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Journal of Pediatric Gastroenterology & Nutrition:
doi: 10.1097/MPG.0b013e31824d5525
Invited Commentaries

Evidence Base for Probiotic Products for the Pediatric Population

Ringel-Kulka, Tamar

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Department of Maternal and Child Health, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC.

Address correspondence and reprint requests to Tamar Ringel-Kulka, MD, MPH, Department of Maternal and Child Health, UNC Gillings School of Global Public Health, University of North Carolina at Chapel Hill, CB# 7445, 421 Pittsboro St, Chapel Hill, NC 27599-7445 (e-mail:

Received 6 December, 2011

Accepted 19 January, 2012

The author and/or spouse received research grants and/or served as consultant and/or participated in advisory-board and/or are speakers for Danisco, General Mills Inc, Procter & Gamble, Salix Pharmaceuticals, Ironwood Pharmaceuticals, Pfizer, GSK, Smart-Pill, Prometheus, and CheckCap.

There is increased interest in the use of probiotics to promote health and to reduce risk, prevent or treat certain disease conditions. Concurrently, there has been a surge in the development and marketing of probiotic products (1). In a recent study, more than one-third of the 131 adults surveyed reported using probiotics to alleviate gastrointestinal symptoms (2). The majority of these users reported having begun probiotics regimens on their own behest, based on anecdotal evidence, rather than by recommendation from a health care professional. The increase in availability and use of probiotics does not necessarily reflect consumers’ satisfaction with these products. In the aforementioned study, there were no differences in treatment satisfaction between subjects who took probiotics and those who did not (2). This can be explained in part by a mismatch between the intended use of a product and the condition(s) for which that product is beneficial/recommended. All probiotics are not alike, and a specific single or mixed strain of probiotics may be useful for one condition and not helpful for another (3). Unfortunately, it is not always easy to identify evidence for the specific efficacy of a probiotic product. Often, the probiotics that are tested and reported in the literature are not available to the public in stores. Furthermore, some products marketed to the public do not have data to support their use for specific symptoms/conditions. Moreover, when the product's marketed name is not mentioned in the literature, further confusion may be generated. A sufficient evidence base is an important consideration for health professionals (4) and consumers when choosing a probiotic product for a specific condition in a specific population (eg, adults/children, community/hospital). Clarification of intended use and remediation of the marketing–evidence gap is important, not only for causing the desired benefit but also to shape the recommendations of health professionals and clinical guidelines and generate consumer trust in a specific probiotic product.

The amelioration of acute gastroenteritis (AGE) in children younger than 5 years is an example of a disease-, population-, and strain-specific application of probiotics, with substantial clinical evidence supporting its efficacy. AGE is a major cause of morbidity, with 3–5 billion cases per year in children younger than 5 years (5), with a mortality rate of 1.87 million deaths annually in this age group (6), and is responsible for 67,000 hospitalizations per year (7). Probiotics have been suggested and tested as adjuvant therapy for rehydration, the criterion standard of therapy (8,9). A Cochrane meta-analysis concluded that probiotics appear to be safe and have clear beneficial effects in shortening disease duration and reducing stool frequency in acute infectious diarrhea when used in addition to rehydration in children (10). Similarly, clinical guidance from the American Academy of Pediatrics suggests that there is some evidence to support the use of probiotics in otherwise healthy infants and young children early in the course of diarrhea from acute viral gastroenteritis, and that probiotics supplementation can reduce the duration of diarrhea (11). A 2011 review by Guandalini (12) concluded that specific probiotic strains, mostly Lactobacillus GG and Saccharomyces boulardii (SB), are beneficial in the treatment of acute watery diarrhea in children, particularly cases caused by rotavirus. More specifically, a meta-analysis of the use of SB in AGE showed a reduction in the duration of diarrhea from AGE by an average of 1 day in otherwise healthy infants and children (13,14); however, there are limitations to the conclusions resulting from compiling data from studies with different age groups and in different settings. Therefore, more research is needed to provide insight into the effect of specific probiotics in different settings.

In a well-designed, double-blind, placebo-controlled study, Corrêa et al (15) compared the effect of probiotic supplementation with placebo on hospitalized children with acute nonbloody gastroenteritis. They studied the commercially available probiotic yeast, SB, purchased in a local pharmacy. The per-protocol analysis showed reduction in the duration of diarrhea in children receiving SB compared with the placebo group. Furthermore, in a subanalysis, the investigators found a significant difference in days of diarrhea between the probiotics and placebo only in a subgroup of children who tested positive for rotavirus, suggesting that this treatment is effective for specific types of gastroenteritis. The study provides additional evidence and strengthens the notion that intervention with probiotics, specifically SB, for the treatment of viral AGE (particularly those with rotavirus) is warranted, and that supplementation should start within 72 hours of illness onset.

It is important to determine whether SB is beneficial in alleviating other AGE symptoms (eg, fever, vomiting) and whether the demonstrated reduction in bowel movements was associated with reduced health care use/costs (eg, reduced days of hospitalization) or societal costs (eg, care giver work absenteeism) and cost-effectiveness. This information is important when considering guidelines and population recommendations and particularly so in the case of viral AGE, because of the availability and widespread use of rotavirus vaccination (16).

Further studies are needed, especially with products presently available and marketed for children, to help guide the appropriate condition, settings, and regimen for use of various probiotic strains.

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