Protexin Veterinary Synbiotic D-C Daily probiotic and prebiotic capsules for dogs and cats (Pack of 1, 50 Capsules)

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Chang, Y. S. et al. Synbiotics for prevention and treatment of a dermatitis: a meta-analysis of randomized clinical trials. JAMA Pediatr. 170, 236–242 (2016). This meta-analysis provides evidence that supports the use of synbiotics for the treatment of atopic dermatitis, which is thought to be associated with altered gut microbiota that promote an environment that is more susceptible to allergic disease. Rammohan, A. et al. Synbiotics in surgery for chronic pancreatitis: are they truly effective? A single-blind prospective control trial. Ann. Surg. 262, 31–37 (2015). Kukkonen, K. et al. Probiotics and prebiotic galacto-oligosaccharides in the prevention of allergic diseases: a randomized, double-blind, placebo-controlled trial. J. Allergy Clin. Immunol. 119, 192–198 (2007). Mofidi, F. et al. Synbiotic supplementation in lean patients with non-alcoholic fatty liver disease: a pilot, randomised, double-blind, placebo-controlled, clinical trial. Br. J. Nutr. 117, 662–668 (2017). Basturk, A., Artan, R. & Yilmaz, A. Efficacy of synbiotic, probiotic, and prebiotic treatments for irritable bowel syndrome in children: a randomized controlled trial. Turk. J. Gastroenterol. 27, 439–443 (2016).

Does treatment of dysbiosis improve outcomes in cancer patients and in patients with other diseases? The structure and purity of the substrate should be stated and characterized by appropriate chemical analyses. This process includes testing for microbial and other contaminants as per regulatory standards for the country of sale. The level of purity required will depend on what is needed to ensure a consistent performance and safety of the product. The level of active substrate in commercial preparations of prebiotics available worldwide ranges considerably, often from 35% to 99% 17, 18, 19. The monosaccharides and disaccharides carried over from the production process that are present in prebiotic preparations are typically digested and absorbed by the host in the upper gastrointestinal tract after oral ingestion. A relevant issue is whether the material used in the formulation is sufficient to deliver a consistent dose of the active component and result in reproducible selective utilization by microorganisms and beneficial health effect(s) in the target host. This issue highlights that studies should communicate the content of the active ingredient being tested in addition to the quantity of the overall product. For example, a 6 g dosage of 50% pure galacto-oligosaccharides would provide 3 g of the active substrate and should be reported as such.

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There is minimal regulation or oversight with regards to efficacy, safety, and quality control of manufacturing. Typically, regulation is focused on the legitimacy of any health claims that are made. For these reasons, caution should be exercised when using over the counter probiotics that have not gone through clinical trials. There are a few probiotics that have been clinically studied in dogs and may be useful for patients with intestinal dysbiosis. They have been evaluated in patients with inflammatory bowel disease (IBD), chronic diarrhea, and other disease states. Visbiome is one example, and this product is composed of 8 bacterial strains and has been tested in over 70 human clinical trials. This probiotic is well tolerated in dogs and has been tested and found effective in patients with IBD in multiple canine clinical trials 2,3. Proviable Forte is another product that has been studied. It contains 7 beneficial bacterial strains and has been shown to help ameliorate antibiotic-associated gastrointestinal signs in dogs, in combination with Saccharomyces boulardii. 4 Saccharomyces boulardii is a yeast probiotic that is indicated for treatment of acute and chronic enteropathies in humans. There are a variety of products on the market containing this yeast probiotic. Saccharomyces boulardii was found to be an effective treatment in dogs with chronic enteropathies in a double-blinded, placebo-controlled study in dogs with IBD. 5 When patients undergo treatment for intestinal dysbiosis, there are symptoms that owners may notice as the patient undergoes detoxification of their gastrointestinal tract: Maneerat, S. et al. Consumption of Bifidobacterium lactis Bi-07 by healthy elderly adults enhances phagocytic activity of monocytes and granulocytes. J. Nutr. Sci. 2, e44 (2013). Panigrahi, P. et al. A randomized synbiotic trial to prevent sepsis among infants in rural India. Nature 548, 407–412 (2017). This paper discussed the use of a synbiotic consisting of Lactobacillus plantarum and fructo-oligosaccharides in a large (4,500 participants) intervention study to protect infants against sepsis.

Dethlefsen, L. & Relman, D. A. Incomplete recovery and individualized responses of the human distal gut microbiota to repeated antibiotic perturbation. Proc. Natl Acad. Sci. USA 108, 4554–4561 (2011). No governing agency oversees the label claims on probiotics. Products are most likely to be of good quality if they were produced by a reputable manufacturer and underwent clinical study.

Composition

Studies on a synergistic synbiotic that compare the synbiotic to the control can provide supportive evidence but do not constitute the primary evidence needed to confirm a synergistic synbiotic. Instead, a study including the combination, the substrate alone, the live microorganisms alone and a control should be conducted. Using an appropriate statistical model, the aim is to demonstrate that the combined effect is better than the estimated effects of each component separately. Evidence of selective utilization of the substrate by the co-administered live microorganism must be obtained from the same trial demonstrating the health benefit. Trials for complementary synbiotics

Land MH, Rouster-Stevens K, Woods CR, et al. Lactobacillus sepsis associated with probiotic therapy. Pediatrics 2005;115(1):178-181. Synbiotics present challenges for researchers, including deciphering mechanisms underlying the health benefit and proving that the microbiota are modulated via complementary or synergistic means. Unless appropriate experimental methods of verification are used, the product under assessment should not be referred to as ‘synbiotic’. Hadi, A., Mohammadi, H., Miraghajani, M. & Ghaedi, E. Efficacy of synbiotic supplementation in patients with nonalcoholic fatty liver disease: a systematic review and meta-analysis of clinical trials: Synbiotic supplementation and NAFLD. Crit. Rev. Food Sci. Nutr. 59, 2494–2505 (2019).Sergeev, I. N., Aljutaily, T., Walton, G. & Huarte, E. Effects of synbiotic supplement on human gut microbiota, body composition and weight loss in obesity. Nutrients 12, 222 (2020). A statistician’s involvement in the design phase of a study will provide confidence that the sample size is sufficient for the defined outcomes using intention-to-treat analysis. Mediation analyses might be useful to assess whether microbiota effects are contributing to the health benefit. Ancillary analyses, which could include population subgroups, responders versus non-responders or exploratory microbiota analyses should be pre-specified.

The WHO definition of probiotics stresses that health benefits need to be demonstrated before a strain of bacteria can be designated as a probiotic. In the U.S., the Food and Drug Administration does not regulate probiotics; therefore, no governing agency oversees the label claims of probiotic products. The most commonly used probiotic strains in commercial products are lactic acid–producing bacteria (e.g., Lactobacillus, Enterococcus, Streptococcus, and Bifidobacterium species), which have traditionally been associated with health benefits. However, clinical studies have also demonstrated health benefits from other microorganisms, including specific strains of Escherichia coli 13 and yeasts (e.g., Saccharomyces boulardii), 7,14 which are also commercially available as probiotics. Liu, L., Li, P., Liu, Y. & Zhang, Y. Efficacy of probiotics and synbiotics in patients with nonalcoholic fatty liver disease: a meta-analysis. Dig. Dis. Sci. 64, 3402–3412 (2019). This meta-analysis highlights the benefits of synbiotics for the hallmarks of non-alcoholic fatty liver disease, liver steatosis, liver enzymes, lipid profiles and liver stiffness. Coyte, K. Z., Schluter, J. & Foster, K. R. The ecology of the microbiome: networks, competition, and stability. Science 350, 663–666 (2015). NIH National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm (2018).U.S. Food and Drug Administration. Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-evidence-based-review-system-scientific-evaluation-health-claims (2009). Secretaria de Politicas, Regulacion e Institutos, Ministerio de Salud, Argentina. Codigo Alimentario Argentino [Spanish] http://www.anmat.gov.ar/webanmat/Legislacion/Alimentos/Resolucion_Conjunta_261-2011_y_22-2011.pdf (2011). Rossi, M. et al. Synbiotics easing renal failure by improving gut microbiology (SYNERGY): a randomized trial. Clin. J. Am. Soc. Nephrol. 11, 223–231 (2016).