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

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Probiotics are live microorganisms, prebiotics are nondigestible food ingredients that support resident intestinal bacteria, and synbiotics are a combination of both. D’Angelo, S., Fracassi, F., Bresciani, F., Galuppi, R., Diana, A., Linta, N., Bettini, G., Morini, M., Pietra, M., 2018. Effect of Saccharomyces boulardii in dogs with chronic enteropathies: double-blinded, placebo-controlled study. Veterinary Record.. doi:10.1136/vr.104241 Regulatory authorities are primarily focused on two issues: product safety and product labelling. These encompass both truthfulness and compliance with regulatory statutes. Even if the term synbiotic is not included in governmental guidelines or regulations, the use of our proposed scientific definition of the term will aid regulatory oversight of products labelled as ‘synbiotic’. In a hypothetical study, an established prebiotic substrate (for example, GOS or inulin) at the dose shown to be both selectively utilized and have a health benefit (primary outcome showing improved probably of response) is combined with an established probiotic at the dose shown to have a health benefit in the same target host. This combination product is tested and shown to confer a health benefit compared with the control (not necessarily the same benefit as previously tested for the probiotic and prebiotic). This product would meet our definition of a complementary synbiotic. 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).

Davis, L. M., Martinez, I., Walter, J. & Hutkins, R. A dose dependent impact of prebiotic galactooligosaccharides on the intestinal microbiota of healthy adults. Int. J. Food Microbiol. 144, 285–292 (2010).Nixon SL, Rose L, Muller AT. Efficacy of an orally administered anti-diarrheal probiotic paste (Pro-Kolin Advanced) in dogs with acute diarrhea: a randomized, placebo-controlled, double-blinded clinical study. J Vet Intern Med 2019;33(3):1286-1294. The panel urges stakeholders to carefully consider context for communications to consumers on the health benefits of synbiotics. The overall impression of any communication should lead consumers to understand the claim in a manner that is consistent with the evidence; any misleading use of the term constitutes misuse. Communication of the tested health benefit must accurately reflect what was reported in the clinical trial; results should not be extrapolated to health conditions, populations or synbiotics that have not been studied. Regulators Aktas MS, Ozkanlar Y. Efficacy of Saccharomyces boulardii as a probiotic in dogs with lincomycin induced diarrhoea. Bull Vet Inst Pulawy 2007;51(3):365-369. Bafeta, A., Koh, M., Riveros, C. & Ravaud, P. Harms reporting in randomized controlled trials of interventions aimed at modifying microbiota: a systematic review. Ann. Intern. Med. 169, 240–247 (2018).

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. Government of Canada. Accepted Claims about the Nature of Probiotic Microorganisms in Food https://www.canada.ca/en/health-canada/services/food-nutrition/food-labelling/health-claims/accepted-claims-about-nature-probiotic-microorganisms-food.html (2009). Every patient is different and there is not a universal treatment protocol for every patient. The treatment usually involves a combination of diet change, digestive enzymes, bacterial probiotics, and sometimes includes the addition of antibiotics (tylosin or metronidazole typically) for a short period of time, or the addition of a yeast probiotic such as Saccharomyces boulardii. What is the Best Diet to Establish a Healthy Microbiome? Gerardo, N. & Hurst, G. Q&A: friends (but sometimes foes) within: the complex evolutionary ecology of symbioses between host and microbes. BMC Biol. 15, 126 (2017).

Samimi, M. et al. The effects of synbiotic supplementation on metabolic status in women with polycystic ovary syndrome: a randomized double-blind clinical trial. Probiotics Antimicrob. Prot. 11, 1355–1361 (2019). Governement of Canada. Questions and Answers on Probiotics https://www.canada.ca/en/health-canada/services/food-nutrition/food-labelling/health-claims/questions-answers-probiotics.html (2009). Food and Agriculture Organization of the United Nations/World Health Organization. Guidelines for the Evaluation of Probiotics in Food. who.int/foodsafety/fs_management/en/probiotic_guidelines.pdf. Accessed May 2020.

Generating this evidence requires appropriately designed, adequately powered experimental trials conducted on the target host. These studies should follow standard human trial design and reporting guidelines 48 and consider best practices for diet–microbiota research 49. The study should also meet the criteria outlined in CONSORT 48 and should be registered, including a description of all outcomes, prior to recruitment. These CONSORT criteria include guiding principles for microorganisms, microbiota-related compliance and outcome measures, relevant subgroups, and statistical considerations for evaluating the microbiota as a mediator of clinical effects. Probiotics are beneficial bacteria that can help to re-establish the normal microbiota. They are particularly effective when delivered together with a prebiotic, a source of nutrition that stimulates growth. Garcia-Mazcorro JF, Lanerie DJ, Dowd SE, et al. Effect of a multi-species synbiotic formulation on fecal bacterial microbiota of healthy cats and dogs as evaluated by pyrosequencing. FEMS Microbiol Ecol 2011;78(3):542-554. Rossi, G., Pengo, G., Caldin, M., Palumbo Piccionello, A., Steiner, J.M., Cohen, N.D., Jergens, A.E., Suchodolski, J.S., 2014. Comparison of Microbiological, Histological, and Immunomodulatory Parameters in Response to Treatment with Either Combination Therapy with Prednisone and Metronidazole or Probiotic VSL#3 Strains in Dogs with Idiopathic Inflammatory Bowel Disease. PLoS ONE.. doi:10.1371/journal.pone.0094699Scientists involved in the publication process (authors, editors, reviewers) should use the term synbiotic correctly and reject erroneous or unsupported use of the term. Even if a given treatment fails to demonstrate an effect (that is, acceptance of the null hypothesis) in a well-conducted study, such results still warrant publication 93. Industry The most promising applications for probiotics are treatment of acute uncomplicated diarrhea, prevention of stress diarrhea, prevention of antibiotic-associated GI signs, and adjunct therapy for chronic enteropathies ( TABLE 1 ). Probiotics need 1 to 3 days to colonize the intestines. 19 When the goal is prevention of stress-related diarrhea (during periods of weaning, boarding, or traveling or for working dogs), prophylactic administration of a probiotic a few days to weeks ahead of the event may increase success. Similarly, if the goal is prevention of antibiotic-associated GI signs, administering probiotics a few days ahead of a procedure will increase success. Within this definition, ‘host’ microorganisms comprise both autochthonous (resident or colonizing the host) and allochthonous (externally applied, such as probiotics) microorganisms, either of which can be targets for the substrate contained in the synbiotic. Olesen, M. & Gudmand-Hoyer, E. Efficacy, safety, and tolerability of fructooligosaccharides in the treatment of irritable bowel syndrome. Am. J. Clin. Nutr. 72, 1570–1575 (2000).

David, L. A. et al. Diet rapidly and reproducibly alters the human gut microbiome. Nature 505, 559–563 (2014). Barry KA, Middelbos IS, Vester Boler BM, et al. Effects of dietary fiber on the feline gastrointestinal metagenome. J Proteome Res 2012;11(12):5924-5933. Hill, C. et al. Expert consensus document. The International Scientific Association for Probiotics and Prebiotics consensus statement on the scope and appropriate use of the term probiotic. Nat. Rev. Gastroenterol. Hepatol. 11, 506–514 (2014). Important paper updating the probiotic concept. Sharpton, S. R., Maraj, B., Harding-Theobald, E., Vittinghoff, E. & Terrault, N. A. Gut microbiome-targeted therapies in nonalcoholic fatty liver disease: a systematic review, meta-analysis, and meta-regression. Am. J. Clin. Nutr. 110, 139–149 (2019).

Soleimani, A. et al. The effects of synbiotic supplementation on metabolic status in diabetic patients undergoing hemodialysis: a randomized, double-blinded, placebo-controlled trial. Probiotics Antimicro. Prot. 11, 1248–1256 (2019). Nikbakht, E. et al. Effect of probiotics and synbiotics on blood glucose: a systematic review and meta-analysis of controlled trials. Eur. J. Nutr. 57, 95–106 (2018). Eslamparast, T. et al. Synbiotic supplementation in nonalcoholic fatty liver disease: a randomized, double-blind, placebo-controlled pilot study. Am. J. Clin. Nutr. 99, 535–542 (2014).