Labdoor analyzed 12 of the best-selling probiotic supplements for children in the United States. Tests were performed on total bacteria, genera-specific bacteria, and potential contaminants (mold, yeast, and harmful bacteria, including E.coli O157:H7, Salmonella spp., and S. aureus).
Products in this batch varied widely in label accuracy and projected efficacy. One product had virtually none of the total CFUs it claimed while another had 620% more. Three of seven products that specified strains were projected to be effective for health conditions like infectious diarrhea, constipation, and childhood eczema according to research referenced in AEP's (Alliance for Education on Probiotics) Clinical Guides to Probiotics Products1,2. Seven products claimed "proprietary blends". Seven products had more than 1 billion CFUs/serving of total viable bacteria, which researchers report is a generally effective amount3. All products passed screenings for contaminating yeast, mold, and select bacteria.
Products ranged from having practically none of their total CFU claims to having more than seven times their claims.
Scoring: Label Accuracy scores for this category are comprised of subscores for total bacteria claims (60%), claims for individual genera (25%), and claims for remaining bacteria at the end of shelf life (15%). Products were penalized based on discrepancies between these claims and measured amounts. In cases where claims were not made, products received zero points.
Results: We found that products ranged from having practically none of the total CFUs they claimed to having more than seven times their claims. About half (7 of 12) of the products had more total bacteria than claimed. Of the products that specified amounts of individual genera, measured genera amounts ranged from -88% to +620% compared to label claims.
All products passed screenings for contaminating yeast, mold, and select harmful bacteria.
Scoring: Product Purity scores for this category are comprised of subscores for contaminating yeast and mold, E. coli O157:H7, Salmonella spp., and Staphylococcus aureus. Threshold limits of 100 CFU/g of combined yeast and mold and non-detectable levels of the listed bacteria were applied based on guides from the U.S. Pharmacopeia5,6 and FDA7.
Results: All 12 products in this batch passed purity screenings for the above contaminants.
All products recorded minimal fibers, sugars, and carbohydrates.
Scoring: Nutritional Value scores for this category are based on a comparison of products' key macronutrients and micronutrients to recommended daily allowances and limits8,9,10.
Results: All products in this batch scored above 90 (out of 100) in Nutritional Value, recording minimal levels of calories, fibers, sugars, and carbohydrates. Capsule formulations recorded no added sugars, while gummy products recorded an average of 0.6 g/serving.
Four products recorded additives that CSPI cautions against, including guar gum, artificial flavors, and propyl gallate.
Scoring: Ingredient Safety scores for this category are comprised of subscores for inactive ingredients based on CSPI's categorization of additives with risk4 (90%) and whether products listed strain designations on their label (10%). Both the WGO (World Gastroenterology Organisation) and WHO (World Health Organization) have taken a firm stance that specific strains should be disclosed on labels by manufacturers11,12.
Results: Four products recorded additives that CSPI cautions against, including guar gum, artificial flavors, and propyl gallate. Probiotics are generally considered safe for children. For adults, upset stomach may appear with a dose of around 1-2 billion CFUs3. People who have limited immune function, take certain medications, or are critically ill may experience severe side effects13. Allergic reactions may also be possible due to products potentially containing residual milk protein allergens14. Please consult your doctor before and during probiotics use.
Seven of 12 products were projected to be generally effective based on exceeding 1 billion CFUs of total viable bacteria.
Scoring: Projected Efficacy scores for this category were calculated as follows: First, if claimed strains exceeded effective thresholds as reported in the children's section of the AEP and WGO's Clinical Guides1,2, products received full points (100%). If not, products were awarded points based on how much of the effective strain thresholds they measured (50%), whether they met a general effectiveness threshold of 1 billion total CFUs3 (40%), and how long they would remain above the 1 billion total CFU threshold given bacterial decay (10%).
Results: Seven products exceeded the generally effective threshold of 1 billion total CFUs. Of the seven products that specified the strains they contained, three measured levels reported to be effective according to the AEP Guides. In these cases, relevant health conditions include: day-care infections and infectious diarrhea, antibiotic-associated diarrhea, constipation, IBS (irritable bowel syndrome), and eczema.
- 1AEP. (2016). Clinical Guide to Probiotic Products - Available in the US: 2017 Edition.
- 2AEP. (2016). Clinical Guide to Probiotic Products - Available in Canada: 2017 Edition.
- 3Boyle RJ, et al. (2006). Probiotic use in clinical practice: what are the risks?. American Society for Clinical Nutrition. 83(6):1256-1264.
- 4CSPI. (2017). Chemical Cuisine.
- 5USP. (2017). Microbiological Procedures for Absence of Specified Microorganisms - Nutritional and Dietary Supplements. 29(1):287.
- 6USP. (2017). Microbiological Attributes of Nonsterile Nutritional and Dietary Supplements. 30(5):1818.
- 7FDA. (2001). Bacteriological Analytical Manual Chapter 12 Staphylococcus aureus.
- 8USDA. (2007). The Food Supply and Dietary Fiber: Its Availability and Effect on Health.
- 9Slavin J & Justin C. (2014). Carbohydrates. Advances in Nutrition. 5:760-761.
- 10WHO. (2015). Guideline: Sugars intake for adults and children.
- 11WGO. (2017). World Gastroenterology Organisation Global Guidelines - Probiotics and Prebiotics.
- 12FAO and WHO. (2002). Guidelines for the Evaluation of Probiotics in Food.
- 13Verna EC. Use of probiotics in gastrointestinal disorders: what to recommend?. Therapeutic Advances in Gastroenterology. 3(5):307-319.
- 14Sanders ME, et al. (2010). Safety assessment of probiotics for human use. Gut Microbes. 1(3):164-185.