Healey, G. et al. Habitual dietary fibre intake influences gut microbiota response to an inulin-type fructan prebiotic: a randomised, double-blind, placebo-controlled, cross-over, human intervention study. Br. J. Nutr. 119, 176–189 (2018). This study demonstrated that people with a high dietary fibre intake had a greater gut microbiota response and are therefore more likely to benefit from an inulin-type fructan prebiotic than those with a low dietary fibre intake.

ISAPP is a non-profit collaboration of scientists dedicated to advancing scientific excellence and providing objective, science-based information on probiotics and prebiotics. The organization’s activities are funded by companies involved in the sale of probiotics and prebiotics, but ISAPP is guided by an international, all-volunteer academic board that functions independently. This ISAPP-organized panel was composed of experts in microbiology, nutrition and gastrointestinal physiology, including many who were involved in the latest updates of the probiotic 12 and prebiotic 13 definitions according to ISAPP. Panellists were charged with accomplishing the following goals: consider what a synbiotic is and provide a clear, concise and testable definition; suggest the appropriate experimental conditions necessary to establish synbiotic activity; describe the evidence required to demonstrate the health benefits and establish safety; and provide guidance for stakeholders, including researchers, industry, public health professionals and regulatory agencies. Holmes, E., Li, J. V., Marchesi, J. R. & Nicholson, J. K. Gut microbiota composition and activity in relation to host metabolic phenotype and disease risk. Cell Metab. 16, 559–564 (2012). 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).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). The intervention should be fully described to enable replication of the study. This entails an adequate description of substrate and live microorganism dosages, specification of the microbial strain, the structure and purity of the substrate, and the timing and route of administration of the intervention. Subject compliance with an oral intervention can include measurement of the administered microorganisms in stool. A synbiotic can be applied to intestinal or extra-intestinal microbial ecosystems and might be formulated into products fitting an array of regulatory categories (such as foods, non-foods, feeds, drugs or nutritional supplements). Maldonado-Gomez, M. X. et al. Stable engraftment of Bifidobacterium longum AH1206 in the human gut depends on individualized features of the resident microbiome. Cell Host Microbe 20, 515–526 (2016).

Favretto, D. C., Pontin, B. & Moreira, T. R. Effect of the consumption of a cheese enriched with probiotic organisms ( Bifidobacterium lactis Bi-07) in improving symptoms of constipation. Arq. Gastroenterol. 50, 196–201 (2013).Kasatpibal, N. et al. Effectiveness of probiotic, prebiotic, and synbiotic therapies in reducing postoperative complications: a systematic review and network meta-analysis. Clin. Infect. Dis. 64 (Suppl. 2), S153–S160 (2017). Alexander, N. et al. Achieving a transparent, actionable framework for public-private partnerships for food and nutrition research. Am. J. Clin. Nutr. 101, 1359–1363 (2015).

Sirvan, B. N., Usta, M. K., Kizilkan, N. U. & Urganci, N. Are synbiotics added to the standard therapy to eradicate Helicobacter pylori in children beneficial? A randomized controlled study. Euroasian J. Hepatogastroenterol. 7, 17–22 (2017). Modi, S. R., Collins, J. J. & Relman, D. A. Antibiotics and the gut microbiota. J. Clin. Invest. 124, 4212–4218 (2014). Meance, S. et al. Recent advances in the use of functional foods: effects of the commercial fermented milk with Bifidobacterium animalis strain DN-173 010 and yoghurt strains on gut transit time in the elderly. Microb. Ecol. Health Dis. 15, 15–22 (2003). The gastrointestinal (GI) tract of animals harbors various microorganisms along with their collective genomes. 2,3 The estimated total microbial load in the intestine is approximately 100 trillion microbial cells, representing approximately 100 times more microbial genes than the host genome. Cappello, C., Tremolaterra, F., Pascariello, A., Ciacci, C. & Iovino, P. A randomised clinical trial (RCT) of a symbiotic mixture in patients with irritable bowel syndrome (IBS): effects on symptoms, colonic transit and quality of life. Int. J. Colorectal Dis. 28, 349–358 (2013).

Sizes Available

Design of a placebo or control is driven by the comparisons of interest. Often, a fully inert control is preferred. For formulations within pills or sachets, a low dose of highly digestible ingredients (such as maltodextrin or corn starch) or slowly fermentable fibre (such as microcrystalline cellulose) are acceptable placebos, which enables double blinding. For interventions composed of a food or beverage, the control group must be carefully considered, including differences in flavour, texture and nutrient content. These factors will also determine whether the study can be considered as a single-blinded or double-blinded design. Outcome

Probiotics: (180 million CFU/g) Lactobacillus acidophilus, L.casei, L. salivarius, L.plantarum, L.rhamnosus, L.brevis, Bifidobacterium bifidum, B.lactis, S. thermophilus.

Andriulli, A. et al. Clinical trial on the efficacy of a new symbiotic formulation, Flortec, in patients with irritable bowel syndrome: a multicenter, randomized study. J. Clin. Gastroenterol. 42, S218–S223 (2008). White R, Atherly T, Guard B, et al. Randomized, controlled trial evaluating the effect of multi-strain probiotic on the mucosal microbiota in canine idiopathic inflammatory bowel disease. Gut Microbes 2017;8(5):451-466. 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. Pilla R, Guard BC, Steiner JM, et al. Administration of a synbiotic containing Enterococcus faecium does not significantly alter fecal microbiota richness or diversity in dogs with and without food-responsive chronic enteropathy. Front Vet Sci 2019;6:277. van den Nieuwboer, M., Claassen, E., Morelli, L., Guarner, F. & Brummer, R. J. Probiotic and synbiotic safety in infants under two years of age. Benef. Microbes 5, 45–60 (2014).