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Volumn 1, Issue 4, 2010, Pages 243-253

Guide to designing, conducting, publishing and communicating results of clinical studies involving probiotic applications in human participants

Author keywords

Clinical trials; Guidelines; Human; Probiotics; Study design

Indexed keywords


EID: 79251480110     PISSN: 19490976     EISSN: 19490984     Source Type: Journal    
DOI: 10.4161/gmic.1.4.12707     Document Type: Review
Times cited : (57)

References (80)
  • 2
    • 84900433111 scopus 로고    scopus 로고
    • General Considerations for Clincial Trials
    • European Medicines Agency E
    • European Medicines Agency E. General Considerations for Clincial Trials. ICH Topic E8 1998.
    • (1998) ICH Topic
  • 4
    • 4644239296 scopus 로고    scopus 로고
    • Maintaining remission of ulcerative colitis with the probiotic Escherichia coli Nissle 1917 is as effective as with standard mesalazine
    • Kruis W, Fric P, Pokrotnieks J, Lukás M, Fixa B, Kascák M, et al. Maintaining remission of ulcerative colitis with the probiotic Escherichia coli Nissle 1917 is as effective as with standard mesalazine. Gut 2004; 53:1617-23.
    • (2004) Gut , vol.53 , pp. 1617-1623
    • Kruis, W.1    Fric, P.2    Pokrotnieks, J.3    Lukás, M.4    Fixa, B.5    Kascák, M.6
  • 5
    • 0842348937 scopus 로고    scopus 로고
    • Strength of recommendation taxonomy (SORT): A patient-centered approach to grading evidence in the medical literature
    • Ebell M, JS, Weiss B, Woolf S, Susman J, Ewigman B, et al. Strength of recommendation taxonomy (SORT): a patient-centered approach to grading evidence in the medical literature. Am Fam Physician 2004; 69:548-56.
    • (2004) Am Fam Physician , vol.69 , pp. 548-556
    • Ebell, M.1    Weiss, B.2    Woolf, S.3    Susman, J.4    Ewigman, B.5
  • 6
    • 84900437058 scopus 로고    scopus 로고
    • Evidence-Based Review System for the Scientific Evaluation of Health Claims-Final
    • FDA. Guidance for Industry
    • FDA. Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims-Final. In: Nutrition CfFSaA, ed., 2009.
    • (2009) Nutrition CfFSaA
  • 8
    • 77953611072 scopus 로고    scopus 로고
    • CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials
    • Moher D, Hopewell S, Schulz K, Montori V, Gøtzsche P, Devereaux P, et al. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol 2010; 63:e1-37.
    • (2010) J Clin Epidemiol , vol.63
    • Moher, D.1    Hopewell, S.2    Schulz, K.3    Montori, V.4    Gøtzsche, P.5    Devereaux, P.6
  • 9
    • 77950679021 scopus 로고    scopus 로고
    • Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials
    • Schulz K, Altman D, Moher D. CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials. PLoS Med 2010; 7.
    • (2010) PLoS Med , pp. 7
    • Schulz, K.1    Altman, D.2    Moher, D.C.3
  • 10
    • 0006515789 scopus 로고    scopus 로고
    • Incorporating allocation concealment and blinding in randomised controlled trials
    • Haynes R. Incorporating allocation concealment and blinding in randomised controlled trials. Evid Based Med 2000; 5:38.
    • (2000) Evid Based Med , vol.5 , pp. 38
    • Haynes, R.1
  • 11
    • 0035822324 scopus 로고    scopus 로고
    • Systematic reviews in health care: Assessing the quality of controlled clinical trials
    • Jüni P, Altman D, Egger M. Systematic reviews in health care: Assessing the quality of controlled clinical trials. BMJ 2001; 323:42-6.
    • (2001) BMJ , vol.323 , pp. 42-46
    • Jüni, P.1    Altman, D.2    Egger, M.3
  • 13
    • 2042458387 scopus 로고    scopus 로고
    • Strength of recommendation taxonomy (SORT): A patient-centered approach to grading evidence in the medical literature
    • Ebell M, Siwek J, Weiss B, Woolf S, Susman J, Ewigman B, et al. Strength of recommendation taxonomy (SORT): a patient-centered approach to grading evidence in the medical literature. J Am Board Fam Pract 2004; 17:59-67.
    • (2004) J Am Board Fam Pract , vol.17 , pp. 59-67
    • Ebell, M.1    Siwek, J.2    Weiss, B.3    Woolf, S.4    Susman, J.5    Ewigman, B.6
  • 14
    • 70349422112 scopus 로고    scopus 로고
    • Lactococcus lactis subsp. cremoris FC alleviates symptoms of colitis induced by dextran sulfate sodium in mice
    • Nishitani Y, Tanoue T, Yamada K, Ishida T, Yoshida M, Azuma T, et al. Lactococcus lactis subsp. cremoris FC alleviates symptoms of colitis induced by dextran sulfate sodium in mice. Int Immunopharmacol 2009; 9:1444-51.
    • (2009) Int Immunopharmacol , vol.9 , pp. 1444-1451
    • Nishitani, Y.1    Tanoue, T.2    Yamada, K.3    Ishida, T.4    Yoshida, M.5
  • 15
    • 69249248657 scopus 로고    scopus 로고
    • Probiotics and their derivatives as treatments for inflammatory bowel disease
    • Prisciandaro L, Geier M, Butler R, Cummins A, Howarth G. Probiotics and their derivatives as treatments for inflammatory bowel disease. Inflamm Bowel Dis 2009; 15:1906-14.
    • (2009) Inflamm Bowel Dis , vol.15 , pp. 1906-1914
    • Prisciandaro, L.1    Geier, M.2    Butler, R.3    Cummins, A.4    Howarth, G.5
  • 16
    • 59749088586 scopus 로고    scopus 로고
    • Effect of a probiotic preparation (VSL#3) on induction and maintenance of remission in children with ulcerative colitis
    • Miele E, Pascarella F, Giannetti E, Quaglietta L, Baldassano R, Staiano A. Effect of a probiotic preparation (VSL#3) on induction and maintenance of remission in children with ulcerative colitis. Am J Gastroenterol 2009; 104:437-43.
    • (2009) Am J Gastroenterol , vol.104 , pp. 437-443
    • Miele, E.1    Pascarella, F.2    Giannetti, E.3    Quaglietta, L.4    Baldassano, R.5    Staiano, A.6
  • 17
    • 67649703525 scopus 로고    scopus 로고
    • Lactobacillus casei downregulates commensals' inflammatory signals in Crohn's disease mucosa
    • Llopis M, Antolin M, Carol M, Borruel N, Casellas F, Martinez C, et al. Lactobacillus casei downregulates commensals' inflammatory signals in Crohn's disease mucosa. Inflamm Bowel Dis 2009; 15:275-83.
    • (2009) Inflamm Bowel Dis , vol.15 , pp. 275-283
    • Llopis, M.1    Antolin, M.2    Carol, M.3    Borruel, N.4    Casellas, F.5    Martinez, C.6
  • 20
    • 72449206050 scopus 로고    scopus 로고
    • Pro- and synbiotics to control inflammation and infection in patients with multiple injuries
    • Giamarellos-Bourboulis E, Bengmark S, Kanellakopoulou K, Kotzampassi K. Pro- and synbiotics to control inflammation and infection in patients with multiple injuries. J Trauma 2009; 67:815-21.
    • (2009) J Trauma , vol.67 , pp. 815-821
    • Giamarellos-Bourboulis, E.1    Bengmark, S.2    Kanellakopoulou, K.3    Kotzampassi, K.4
  • 21
    • 8344268491 scopus 로고    scopus 로고
    • Numbers and strains of lactobacilli in some probiotic products
    • Coeuret V, Gueguen M, Vernoux J. Numbers and strains of lactobacilli in some probiotic products. Int J Food Microbiol 2004; 97:147-56.
    • (2004) Int J Food Microbiol , vol.97 , pp. 147-156
    • Coeuret, V.1    Gueguen, M.2    Vernoux, J.3
  • 22
    • 33749509177 scopus 로고    scopus 로고
    • Accuracy of species identity of commercial bacterial cultures intended for probiotic or nutritional use
    • Huys G, Vancanneyt M, D'Haene K, Vankerckhoven V, Goossens H, Swings J. Accuracy of species identity of commercial bacterial cultures intended for probiotic or nutritional use. Res Microbiol 2006; 157:803-10.
    • (2006) Res Microbiol , vol.157 , pp. 803-810
    • Huys, G.1    Vancanneyt, M.2    D'Haene, K.3    Vankerckhoven, V.4    Goossens, H.5    Swings, J.6
  • 23
    • 20844438208 scopus 로고    scopus 로고
    • Evaluation of five probiotic products for label claims by DNA extraction and polymerase chain reaction analysis
    • Drisko J, Bischoff B, Giles C, Adelson M, Rao R, McCallum R. Evaluation of five probiotic products for label claims by DNA extraction and polymerase chain reaction analysis. Dig Dis Sci 2005; 50:1113-7.
    • (2005) Dig Dis Sci , vol.50 , pp. 1113-1117
    • Drisko, J.1    Bischoff, B.2    Giles, C.3    Adelson, M.4    Rao, R.5    McCallum, R.6
  • 24
  • 25
    • 54349126970 scopus 로고    scopus 로고
    • High-throughput diversity and functionality analysis of the gastrointestinal tract microbiota
    • Zoetendal E, Rajilic-Stojanovic M, de Vos W. High-throughput diversity and functionality analysis of the gastrointestinal tract microbiota. Gut 2008; 57:1605-15.
    • (2008) Gut , vol.57 , pp. 1605-1615
    • Zoetendal, E.1    Rajilic-Stojanovic, M.2    de Vos, W.3
  • 26
    • 72949091232 scopus 로고    scopus 로고
    • Bacterial community variation in human body habitats across space and time
    • Costello E, Lauber C, Hamady M, Fierer N, Gordon J, Knight R. Bacterial community variation in human body habitats across space and time. Science 2009; 326:1694-7.
    • (2009) Science , vol.326 , pp. 1694-1697
    • Costello, E.1    Lauber, C.2    Hamady, M.3    Fierer, N.4    Gordon, J.5    Knight, R.6
  • 27
    • 69949111703 scopus 로고    scopus 로고
    • The core gut microbiome, energy balance and obesity
    • Turnbaugh P, Gordon J. The core gut microbiome, energy balance and obesity. J Physiol 2009; 587:4153-8.
    • (2009) J Physiol , vol.587 , pp. 4153-4158
    • Turnbaugh, P.1    Gordon, J.2
  • 29
    • 33748113107 scopus 로고    scopus 로고
    • Discrimination of dairy industry isolates of the Lactobacillus casei group
    • Desai A, Shah N, Powell I. Discrimination of dairy industry isolates of the Lactobacillus casei group. J Dairy Sci 2006; 89:3345-51.
    • (2006) J Dairy Sci , vol.89 , pp. 3345-3351
    • Desai, A.1    Shah, N.2    Powell, I.3
  • 31
    • 0033376051 scopus 로고    scopus 로고
    • A polyphasic approach towards the identification of strains belonging to Lactobacillus acidophilus and related species
    • Gancheva A, Pot B, Vanhonacker K, Hoste B, Kersters K. A polyphasic approach towards the identification of strains belonging to Lactobacillus acidophilus and related species. Syst Appl Microbiol 1999; 22:573-85.
    • (1999) Syst Appl Microbiol , vol.22 , pp. 573-585
    • Gancheva, A.1    Pot, B.2    Vanhonacker, K.3    Hoste, B.4    Kersters, K.5
  • 32
    • 77649184816 scopus 로고    scopus 로고
    • Rapid discrimination and classification of the Lactobacillus plantarum group based on a partial dnaK sequence and DNA fingerprinting techniques
    • Huang C, Lee F, Liou J. Rapid discrimination and classification of the Lactobacillus plantarum group based on a partial dnaK sequence and DNA fingerprinting techniques. Antonie Van Leeuwenhoek 2010; 97:289-96.
    • (2010) Antonie Van Leeuwenhoek , vol.97 , pp. 289-296
    • Huang, C.1    Lee, F.2    Liou, J.3
  • 33
    • 70350520168 scopus 로고    scopus 로고
    • Comparison and utilization of repetitive-element PCR techniques for typing Lactobacillus isolates from the chicken gastrointestinal tract
    • Stephenson D, Moore R, Allison G. Comparison and utilization of repetitive-element PCR techniques for typing Lactobacillus isolates from the chicken gastrointestinal tract. Appl Environ Microbiol 2009; 75:6764-76.
    • (2009) Appl Environ Microbiol , vol.75 , pp. 6764-6776
    • Stephenson, D.1    Moore, R.2    Allison, G.3
  • 35
    • 58549107193 scopus 로고    scopus 로고
    • Quantitative strain-specific detection of Lactobacillus rhamnosus GG in human faecal samples by real-time PCR
    • Ahlroos T, Tynkkynen S. Quantitative strain-specific detection of Lactobacillus rhamnosus GG in human faecal samples by real-time PCR. J Appl Microbiol 2009; 106:506-14.
    • (2009) J Appl Microbiol , vol.106 , pp. 506-514
    • Ahlroos, T.1    Tynkkynen, S.2
  • 36
    • 70349898949 scopus 로고    scopus 로고
    • Development and validation of a species-independent functional gene micro-array that targets lactic acid bacteria
    • Weckx S, Allemeersch J, Van der Meulen R, Vrancken G, Huys G, Vandamme P, et al. Development and validation of a species-independent functional gene micro-array that targets lactic acid bacteria. Appl Environ Microbiol 2009; 75:6488-95.
    • (2009) Appl Environ Microbiol , vol.75 , pp. 6488-6495
    • Weckx, S.1    Allemeersch, J.2    Van der Meulen, R.3    Vrancken, G.4    Huys, G.5    Vandamme, P.6
  • 37
    • 65549147992 scopus 로고    scopus 로고
    • Mixed-species genomic microar-ray analysis of fecal samples reveals differential tran-scriptional responses of bifidobacteria in breast- and formula-fed infants
    • Klaassens E, Boesten R, Haarman M, Knol J, Schuren F, Vaughan E, et al. Mixed-species genomic microar-ray analysis of fecal samples reveals differential tran-scriptional responses of bifidobacteria in breast- and formula-fed infants. Appl Environ Microbiol 2009; 75:2668-76.
    • (2009) Appl Environ Microbiol , vol.75 , pp. 2668-2676
    • Klaassens, E.1    Boesten, R.2    Haarman, M.3    Knol, J.4    Schuren, F.5    Vaughan, E.6
  • 38
    • 49449097125 scopus 로고    scopus 로고
    • Differential transcriptional response of Bifidobacterium longum to human milk, formula milk and galactooligosaccharide
    • González R, Klaassens E, Malinen E, de Vos W, Vaughan E. Differential transcriptional response of Bifidobacterium longum to human milk, formula milk and galactooligosaccharide. Appl Environ Microbiol 2008; 74:4686-94.
    • (2008) Appl Environ Microbiol , vol.74 , pp. 4686-4694
    • González, R.1    Klaassens, E.2    Malinen, E.3    de Vos, W.4    Vaughan, E.5
  • 39
    • 52049103837 scopus 로고    scopus 로고
    • Oligonucleotide microarrays for the detection and identification of viable beer spoilage bacteria
    • Weber D, Sahm K, Polen T, Wendisch V, Antranikian G. Oligonucleotide microarrays for the detection and identification of viable beer spoilage bacteria. J Appl Microbiol 2008; 105:951-62.
    • (2008) J Appl Microbiol , vol.105 , pp. 951-962
    • Weber, D.1    Sahm, K.2    Polen, T.3    Wendisch, V.4    Antranikian, G.5
  • 40
    • 78650213986 scopus 로고    scopus 로고
    • Food formats for effective delivery of probiotics
    • Sanders ME, Marco M. Food formats for effective delivery of probiotics. Ann Rev Food Sci Technol 2010; 1:65-85.
    • (2010) Ann Rev Food Sci Technol , vol.1 , pp. 65-85
    • Sanders, M.E.1    Marco, M.2
  • 41
    • 28444455307 scopus 로고    scopus 로고
    • Influence of fermentation time, cryoprotectant and neutralization of cell concentrate on freeze-drying survival, storage stability and acid and bile exposure of Bifidobacterium animalis ssp. lactis cells produced without milk-based ingredients
    • Saarela M, Virkajärvi I, Alakomi H, Mattila-Sandholm T, Vaari A, Suomalainen T, et al. Influence of fermentation time, cryoprotectant and neutralization of cell concentrate on freeze-drying survival, storage stability and acid and bile exposure of Bifidobacterium animalis ssp. lactis cells produced without milk-based ingredients. J Appl Microbiol 2005; 99:1330-9.
    • (2005) J Appl Microbiol , vol.99 , pp. 1330-1339
    • Saarela, M.1    Virkajärvi, I.2    Alakomi, H.3    Mattila-Sandholm, T.4    Vaari, A.5    Suomalainen, T.6
  • 42
    • 62149120210 scopus 로고    scopus 로고
    • Effect of the fermentation pH on the storage stability of Lactobacillus rhamnosus preparations and suitability of in vitro analyses of cell physiological functions to predict it
    • Saarela M, Alakomi H, Puhakka A, Mättö J. Effect of the fermentation pH on the storage stability of Lactobacillus rhamnosus preparations and suitability of in vitro analyses of cell physiological functions to predict it. J Appl Microbiol 2009; 106:1204-12.
    • (2009) J Appl Microbiol , vol.106 , pp. 1204-1212
    • Saarela, M.1    Alakomi, H.2    Puhakka, A.3    Mättö, J.4
  • 43
    • 70350337980 scopus 로고    scopus 로고
    • A probiotic strain of Escherichia coli, Nissle 1917, given orally exerts local and systemic anti-inflammatory effects in lipo-polysaccharide-induced sepsis in mice
    • Arribas B, Rodríguez-Cabezas M, Camuesco D, Comalada M, Bailón E, Utrilla P, et al. A probiotic strain of Escherichia coli, Nissle 1917, given orally exerts local and systemic anti-inflammatory effects in lipo-polysaccharide-induced sepsis in mice. Br J Pharmacol 2009; 157:1024-33.
    • (2009) Br J Pharmacol , vol.157 , pp. 1024-1033
    • Arribas, B.1    Rodríguez-Cabezas, M.2    Camuesco, D.3    Comalada, M.4    Bailón, E.5    Utrilla, P.6
  • 44
    • 65549118300 scopus 로고    scopus 로고
    • Effect of Bacillus subtilis PB6, a natural probiotic on colon mucosal inflammation and plasma cytokines levels in inflammatory bowel disease
    • Selvam R, Maheswari P, Kavitha P, Ravichandran M, Sas B, Ramchand C. Effect of Bacillus subtilis PB6, a natural probiotic on colon mucosal inflammation and plasma cytokines levels in inflammatory bowel disease. Indian J Biochem Biophys 2009; 46:79-85.
    • (2009) Indian J Biochem Biophys , vol.46 , pp. 79-85
    • Selvam, R.1    Maheswari, P.2    Kavitha, P.3    Ravichandran, M.4    Sas, B.5    Ramchand, C.6
  • 45
    • 33751342532 scopus 로고    scopus 로고
    • Oral administration of probiotic bacteria (E. coli Nissle E. coli O83, Lactobacillus casei) influences the severity of dextran sodium sul-fate-induced colitis in BALB/c mice
    • Kokesová A, Frolová L, Kverka M, Sokol D, Rossmann P, Bártová J, et al. Oral administration of probiotic bacteria (E. coli Nissle E. coli O83, Lactobacillus casei) influences the severity of dextran sodium sul-fate-induced colitis in BALB/c mice. Folia Microbiol (Praha) 2006; 51:478-84.
    • (2006) Folia Microbiol (Praha) , vol.51 , pp. 478-484
    • Kokesová, A.1    Frolová, L.2    Kverka, M.3    Sokol, D.4    Rossmann, P.5    Bártová, J.6
  • 46
    • 41449111439 scopus 로고    scopus 로고
    • Improving probiotic function using a patho-biotechnology approach
    • Sleator R, Hill C. Improving probiotic function using a patho-biotechnology approach. Gene Ther Mol Biol 2007; 11:269-74.
    • (2007) Gene Ther Mol Biol , vol.11 , pp. 269-274
    • Sleator, R.1    Hill, C.2
  • 47
    • 77950235521 scopus 로고    scopus 로고
    • Effect of probiotic mix (Bifidobacterium bifi-dum, Bifidobacterium lactis, Lactobacillus acidophilus) in the primary prevention of eczema: A double-blind, randomized, placebo-controlled trial
    • Kim J, Kwon J, Ahn S, Lee S, Han Y, Choi Y, et al. Effect of probiotic mix (Bifidobacterium bifi-dum, Bifidobacterium lactis, Lactobacillus acidophilus) in the primary prevention of eczema: a double-blind, randomized, placebo-controlled trial. Pediatr Allergy Immunol 2010; 21:e386-93.
    • (2010) Pediatr Allergy Immunol , vol.21
    • Kim, J.1    Kwon, J.2    Ahn, S.3    Lee, S.4    Han, Y.5    Choi, Y.6
  • 48
    • 38749107605 scopus 로고    scopus 로고
    • I trial of a Lactobacillus crispatus vaginal suppository for prevention of recurrent urinary tract infection in women
    • Czaja C, Stapleton A, Yarova-Yarovaya Y, Stamm W. Phase I trial of a Lactobacillus crispatus vaginal suppository for prevention of recurrent urinary tract infection in women. Infect Dis Obstet Gynecol 2007; 2007:35387.
    • (2007) Infect Dis Obstet Gynecol , vol.2007 , pp. 35387
    • Czaja, C.1    Stapleton, A.2    Yarova-Yarovaya, Y.3    Stamm, W.4
  • 49
    • 33746709923 scopus 로고    scopus 로고
    • A pilot study evaluating the safety and effectiveness of Lactobacillus vaginal suppositories in patients with recurrent urinary tract infection
    • Uehara S, Monden K, Nomoto K, Seno Y, Kariyama R, Kumon H. A pilot study evaluating the safety and effectiveness of Lactobacillus vaginal suppositories in patients with recurrent urinary tract infection. Int J Antimicrob Agents 2006; 28:30-4.
    • (2006) Int J Antimicrob Agents , vol.28 , pp. 30-34
    • Uehara, S.1    Monden, K.2    Nomoto, K.3    Seno, Y.4    Kariyama, R.5    Kumon, H.6
  • 50
    • 26944489666 scopus 로고    scopus 로고
    • Colon targeted delivery systems: Review of polysaccharides for encapsulation and delivery
    • Kosaraju S. Colon targeted delivery systems: review of polysaccharides for encapsulation and delivery. Crit Rev Food Sci Nutr 2005; 45:251-8.
    • (2005) Crit Rev Food Sci Nutr , vol.45 , pp. 251-258
    • Kosaraju, S.1
  • 51
    • 70349973563 scopus 로고    scopus 로고
    • Escherichia coli Nissle 1917 for probiotic use in piglets: Evidence for intestinal colonization
    • Barth S, Duncker S, Hempe J, Breves G, Baljer G, Bauerfeind R. Escherichia coli Nissle 1917 for probiotic use in piglets: evidence for intestinal colonization. J Appl Microbiol 2009; 107:1697-710.
    • (2009) J Appl Microbiol , vol.107 , pp. 1697-1710
    • Barth, S.1    Duncker, S.2    Hempe, J.3    Breves, G.4    Baljer, G.5
  • 52
    • 17644384404 scopus 로고    scopus 로고
    • Green fluorescent protein for detection of the probiotic microorganism Escherichia coli strain Nissle 1917 (EcN) in vivo
    • Schultz M, Watzl S, Oelschlaeger T, Rath H, Göttl C, Lehn N, et al. Green fluorescent protein for detection of the probiotic microorganism Escherichia coli strain Nissle 1917 (EcN) in vivo. J Microbiol Methods 2005; 61:389-98.
    • (2005) J Microbiol Methods , vol.61 , pp. 389-398
    • Schultz, M.1    Watzl, S.2    Oelschlaeger, T.3    Rath, H.4    Göttl, C.5    Lehn, N.6
  • 53
    • 33750812809 scopus 로고    scopus 로고
    • Detection and distribution of probiotic Escherichia coli Nissle 1917 clones in swine herds in Germany
    • Kleta S, Steinrück H, Breves G, Duncker S, Laturnus C, Wieler L, et al. Detection and distribution of probiotic Escherichia coli Nissle 1917 clones in swine herds in Germany. J Appl Microbiol 2006; 101:1357-66.
    • (2006) J Appl Microbiol , vol.101 , pp. 1357-1366
    • Kleta, S.1    Steinrück, H.2    Breves, G.3    Duncker, S.4    Laturnus, C.5    Wieler, L.6
  • 54
    • 6444232341 scopus 로고    scopus 로고
    • Issues in endpoint selection
    • In: Cato A, Suton L, Cato A, eds., New York: Marcel Dekker Inc
    • Weiss K, Siegel J. Issues in endpoint selection. In: Cato A, Suton L, Cato A, eds. Clinical Drug Trials and Tribulations. New York: Marcel Dekker Inc. 2002; 79-92.
    • (2002) Clinical Drug Trials and Tribulations , pp. 79-92
    • Weiss, K.1    Siegel, J.2
  • 55
    • 0026011647 scopus 로고
    • Mortality and morbidity in patients receiving encainide, flecainide or placebo. The Cardiac Arrhythmia Suppression Trial
    • Echt D, Liebson P, Mitchell L, Peters R, Obias-Manno D, Barker A, et al. Mortality and morbidity in patients receiving encainide, flecainide or placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med 1991; 324:781-8.
    • (1991) N Engl J Med , vol.324 , pp. 781-788
    • Echt, D.1    Liebson, P.2    Mitchell, L.3    Peters, R.4    Obias-Manno, D.5    Barker, A.6
  • 57
    • 17644412369 scopus 로고    scopus 로고
    • Surrogate end points in clinical research: Hazardous to your health
    • Grimes D, Schulz K. Surrogate end points in clinical research: hazardous to your health. Obstet Gynecol 2005; 105:1114-8.
    • (2005) Obstet Gynecol , vol.105 , pp. 1114-1118
    • Grimes, D.1    Schulz, K.2
  • 58
    • 0032053723 scopus 로고    scopus 로고
    • Laboratory data in clinical trials: A a staistician's perspective
    • Chuang-Stein C. Laboratory data in clinical trials: a a staistician's perspective. Controlled Clinical Trials 1998; 19:167-77.
    • (1998) Controlled Clinical Trials , vol.19 , pp. 167-177
    • Chuang-Stein, C.1
  • 59
    • 0037097683 scopus 로고    scopus 로고
    • Quality of life measurement: Bibliographic study of patient assessed health outcome measures
    • Garratt A, Schmidt L, Mackintosh A, Fitzpatrick R. Quality of life measurement: bibliographic study of patient assessed health outcome measures. BMJ 2002; 324:1417.
    • (2002) BMJ , vol.324 , pp. 1417
    • Garratt, A.1    Schmidt, L.2    Mackintosh, A.3    Fitzpatrick, R.4
  • 60
    • 0034072849 scopus 로고    scopus 로고
    • Further validation of the IBS-QOL: A disease-specific quality-of-life questionnaire
    • Drossman D, Patrick D, Whitehead W, Toner B, Diamant N, Hu Y, et al. Further validation of the IBS-QOL: a disease-specific quality-of-life questionnaire. Am J Gastroenterol 2000; 95:999-1007.
    • (2000) Am J Gastroenterol , vol.95 , pp. 999-1007
    • Drossman, D.1    Patrick, D.2    Whitehead, W.3    Toner, B.4    Diamant, N.5    Hu, Y.6
  • 61
    • 33746261692 scopus 로고    scopus 로고
    • FDA, Use in Medical Product Development to Support Labeling Claims
    • FDA. Guidance for Industry: Patient Reported Outcome Measurements, Use in Medical Product Development to Support Labeling Claims., 2006; http://wwwfdagov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282pdf.
    • (2006) Guidance For Industry: Patient Reported Outcome Measurements
  • 62
  • 63
    • 0034871011 scopus 로고    scopus 로고
    • A systematic review of the associations between dose regimens and medication compliance
    • Claxton A, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther 2001; 23:1296-310.
    • (2001) Clin Ther , vol.23 , pp. 1296-1310
    • Claxton, A.1    Cramer, J.2    Pierce, C.3
  • 64
    • 0019328912 scopus 로고
    • Predicting compliance with a regimen of digoxin therapy in family practice
    • Gilbert J, Evans C, Haynes R, Tugwell P. Predicting compliance with a regimen of digoxin therapy in family practice. Can Med Assoc J 1980; 123:119-22.
    • (1980) Can Med Assoc J , vol.123 , pp. 119-122
    • Gilbert, J.1    Evans, C.2    Haynes, R.3    Tugwell, P.4
  • 65
    • 0034232192 scopus 로고    scopus 로고
    • Measuring adherence to antiretroviral medications in clinical trials
    • Miller L, Hays R. Measuring adherence to antiretroviral medications in clinical trials. HIV Clin Trials 2000; 1:36-46.
    • (2000) HIV Clin Trials , vol.1 , pp. 36-46
    • Miller, L.1    Hays, R.2
  • 67
    • 8744229000 scopus 로고    scopus 로고
    • Better reporting of harms in randomized trials: An extension of the CONSORT statement
    • Ioannidis J, Evans S, Gøtzsche P, O'Neill R, Altman D, Schulz K, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 2004; 141:781-8.
    • (2004) Ann Intern Med , vol.141 , pp. 781-788
    • Ioannidis, J.1    Evans, S.2    Gøtzsche, P.3    O'Neill, R.4    Altman, D.5    Schulz, K.6
  • 68
    • 84975171428 scopus 로고    scopus 로고
    • Common Terminology Criteria for Adverse Events (CTCAE)
    • National Institutes of Health
    • National Institutes of Health. Common Terminology Criteria for Adverse Events (CTCAE). In: Services United States Department of Health and Human Services, 2009.
    • (2009) Services United States Department of Health and Human Services
  • 69
    • 0035941525 scopus 로고    scopus 로고
    • Completeness of safety reporting in randomized trials: An evaluation of 7 medical areas
    • Ioannidis J, Lau J. Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas. JAMA 2001; 285:437-43.
    • (2001) JAMA , vol.285 , pp. 437-443
    • Ioannidis, J.1    Lau, J.2
  • 70
    • 0035901579 scopus 로고    scopus 로고
    • The revised CONSORT statement for reporting randomized trials: Explanation and elaboration
    • Altman D, Schulz K, Moher D, Egger M, Davidoff F, Elbourne D, et al. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 2001; 134:663-94.
    • (2001) Ann Intern Med , vol.134 , pp. 663-694
    • Altman, D.1    Schulz, K.2    Moher, D.3    Egger, M.4    Davidoff, F.5    Elbourne, D.6
  • 72
    • 77949651908 scopus 로고    scopus 로고
    • Assessing harms when comparing medical interventions: AHRQ and the Effective Health-Care Program
    • Chou R, Aronson N, Atkins D, Ismaila A, Santaguida P, Smith D, et al. Assessing harms when comparing medical interventions: AHRQ and the Effective Health-Care Program. J Clin Epidemiol 2010; 63:502-12.
    • (2010) J Clin Epidemiol , vol.63 , pp. 502-512
    • Chou, R.1    Aronson, N.2    Atkins, D.3    Ismaila, A.4    Santaguida, P.5    Smith, D.6
  • 73
    • 85020821147 scopus 로고    scopus 로고
    • European Food Safety Authority. Briefing document for Member States and European Commission on the evaluation of Article 13.1 health claims. Parma, Italy, 11 November 2009
    • European Food Safety Authority. Briefing document for Member States and European Commission on the evaluation of Article 13.1 health claims. Parma, Italy, 11 November 2009; EFSA Journal 2009; 7:1386.
    • (2009) EFSA Journal , vol.7 , pp. 1386
  • 74
    • 84900445144 scopus 로고    scopus 로고
    • Health Canada, Food Directorate, Health Products and Food Branch, Health Canada, April 2009. Accessible via
    • Health Canada. Guidance Document-The Use of Probiotic Microorganisms in Food 2009, Food Directorate, Health Products and Food Branch, Health Canada, April 2009. Accessible via http://www.hc-sc.gc.ca/fn-an/alt_formats/hpfb-dgpsa/pdf/legislation/probiotics_guidance-orientation_probiotiques-eng.pdf.
    • Guidance Document-The Use of Probiotic Microorganisms In Food 2009
  • 76
    • 23044483146 scopus 로고    scopus 로고
    • Weight of evidence needed to substantiate a health effect for probiotics and prebiotics: Regulatory considerations in Canada EU and U.S
    • Sanders M, Tompkins T, Heimbach J, Kolida S. Weight of evidence needed to substantiate a health effect for probiotics and prebiotics: regulatory considerations in Canada EU and U.S. Eur J Nutr 2005; 44:303-10.
    • (2005) Eur J Nutr , vol.44 , pp. 303-310
    • Sanders, M.1    Tompkins, T.2    Heimbach, J.3    Kolida, S.4
  • 77
    • 33847675524 scopus 로고    scopus 로고
    • A nonvi-able preparation of Lactobacillus acidophilus is not a probiotic
    • Sanders M, Hamilton J, Reid G, Gibson G. A nonvi-able preparation of Lactobacillus acidophilus is not a probiotic. Clin Infect Dis 2007; 44:886.
    • (2007) Clin Infect Dis , vol.44 , pp. 886
    • Sanders, M.1    Hamilton, J.2    Reid, G.3    Gibson, G.4
  • 78
    • 33947147177 scopus 로고    scopus 로고
    • Probiotic bacteria: Legislative framework-requirements to evidence basis
    • Pineiro M, Stanton C. Probiotic bacteria: legislative framework-requirements to evidence basis. J Nutr 2007; 137:850-3.
    • (2007) J Nutr , vol.137 , pp. 850-853
    • Pineiro, M.1    Stanton, C.2
  • 79
    • 23244451582 scopus 로고    scopus 로고
    • Biomarkers and surrogate markers: An FDA perspective
    • Katz R. Biomarkers and surrogate markers: an FDA perspective. NeuroRx 2004; 1:189-95.
    • (2004) NeuroRx , vol.1 , pp. 189-195
    • Katz, R.1
  • 80
    • 84900460727 scopus 로고    scopus 로고
    • Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403 (r) (6) of the Federal Food, Drug and Cosmetic Act
    • FDA
    • FDA. Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403 (r) (6) of the Federal Food, Drug and Cosmetic Act. In: Office of Nutrition L and Dietary Supplements, ed. 2008.
    • (2008) Office of Nutrition L and Dietary Supplements


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