The design of probiotic studies to substantiate health claims

Gut Microbes

Volumn 2, Issue 5, 2011, Pages 299-305

  Gibson, Glenn R ^a   Brummer, Robert J ^b   Isolauri, Erika ^c   Lochs, Herbert ^d   Morelli, Lorenzo ^e   Ockhuizen, Theo ^f   Rowland, Ian R ^a   Schrezenmeir, Jürgen ^g   Stanton, Catherine ^h   Verbeke, Kristin ⁱ  

^a UNIVERSITY OF READING   (United Kingdom)

^b Örebro University   (Sweden)

^c UNIVERSITY OF TURKU   (Finland)

^d INNSBRUCK MEDICAL UNIVERSITY   (Austria)

^e UCSC   (Italy)

^f Nutricom   (Netherlands)

^g UNIVERSITY HOSPITAL SCHLESWIG HOLSTEIN   (Germany)

^h TEAGASC FOOD RESEARCH CENTRE   (Ireland)

ⁱ LEUVEN FOOD SCIENCE AND NUTRITION RESEARCH CENTRE LFORCE   (Belgium)

Author keywords

Biomarkers; Clinical endpoints; Gut health; Health claims; Immune function; Probiotics; Study design

Indexed keywords

ACETYLSALICYLIC ACID; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; IMMUNOGLOBULIN A; IMMUNOGLOBULIN G; PROBIOTIC AGENT; SHORT CHAIN FATTY ACID;

ALLERGIC DISEASE; ARTICLE; BACTERIAL METABOLISM; BODY MASS; CHRONIC KIDNEY FAILURE; CLOSTRIDIUM DIFFICILE; DIARRHEA; DIET; DISEASE SEVERITY; DRUG EFFICACY; EATING HABIT; FERMENTATION; HEALTH HAZARD; HEALTH STATUS; HUMAN; HYPOTHESIS; IMMUNE RESPONSE; IMMUNE SYSTEM; IMMUNOMODULATION; INTESTINE; INTESTINE FLORA; INTESTINE FUNCTION; IRRITABLE COLON; LARGE INTESTINE; LIFESTYLE; NUTRITIONAL ASSESSMENT; NUTRITIONAL SCIENCE; PROTEIN DEGRADATION; RISK FACTOR; RISK REDUCTION; SACCHAROMYCES BOULARDII; SCIENTIST;

EID: 83255175049     PISSN: 19490976     EISSN: 19490984     Source Type: Journal    
DOI: 10.4161/gmic.2.5.18002     Document Type: Article

References (44)

1. Cary VA, Boullata J. What is the evidence for the use of probiotics in the treatment of inflammatory bowel disease? J Clin Nurs 2010; 19:904-916. PMID:20492035; DOI:10.1111/j.1365-2702.2009.03123.x
2. Tang ML, Lahtinen SJ, Boyle RJ. Probiotics and prebiotics: clinical effects in allergic disease. Curr Opin Pediatr 2010; 22:626-634. PMID:20733491.
3. Sang LX, Chang B, Zhang WL, Wu XM, Li XH, Jiang M. Remission induction and maintenance effect of probiotics of ulcerative colitis: A meta-analysis. World J Gastroenterol 2010; 16:1908-915. PMID:20397271; DOI:10.3748/wjg.v16.i15.1908.
4. O'Hara A, Shanahan F. Mechanisms of action of probiotics in intestinal diseases. Scientific World J 2007; 7:31-46. DOI:10.1100/tsw.2007.26.
5. Ghadimi D, Fölster-Holst R, de Vrese M, Winkler P, Heller KJ, Schrezenmeir J. Effects of probiotic bacteria and their genomic DNA on TH1/TH2- cytokine production by peripheral blood mononuclear cells (PBMCs) of healthy and allergic subjects. Immunobiology 2008; 213:677-692. PMID:18950596; DOI:10.1016/j.imbio.2008.02.001.
6. Donato KA, Gareau MG, Wang YJ, Sherman PM. Lactobacillus rhamnosus GG attenuates interferon- {gamma} and tumour necrosis factoralpha-induced barrier dysfunction and pro-inflammatory signaling. Microbiology 2010; 156:3288-3297. PMID:20656777; DOI:10.1099/mic.0.040139-0.
7. Thomas CM, Versalovic J. Probiotics-host communication: Modulation of signaling pathways in the intestine. Gut Microbes 2010; 1:148-63. PMID:20672012; DOI:10.4161/gmic.1.3.11712.
8. Winkler P, Ghadimi D, Schrezenmeir J, Kraehenbuhl JP. Molecular and cellular basis of microflora-host interactions. J Nutr 2007; 137:756-757. PMID:17311973.
9. http://www.nutraingredients.com/Regulation/EFSAgut-immune-function-meeti ng-leaves-industry-wantingmore
10. http://www.nutraingredients.com/Regulation/Probiotics-industry-unites-ov er-EFSA-claims-treatment
11. http://www.gut-health.eu/
12. Guarner F, Sanders ME, Gibson G, Klaenhammer T, Cabana M, Scott K, et al. Probiotic and prebiotic claims in Europe: seeking a clear roadmap. Br J Nutr 2011; 1-3. PMID:21736772; DOI:10.1017/S0007114511002248.
13. Sanders ME, Heimbach JT, Pot B, Tancredi D, Lenoir- Wijnkoop I, Lähteenmäki-Uutela A, et al. Health claims substantiation for probiotic and prebiotic products. Gut Microbes 2011; 2:127-133. PMID:21646865; DOI:10.4161/gmic.2.3.16174.
14. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:012:0003 :0018:EN:PDF
15. EFSA Panel on Dietetic Products. Nutrition and Allergies (NDA). Guidance on the scientific requirements for health claims related to gut and immune function. EFSA Journal 2011; 9:1984.
16. Canani RB, Costanzo MD, Leone L, Pedata M, Mell R, Calignano A. Potential beneficial effects of butyrate on intestinal and extraintestinal diseases. World J Gastroenterol 2011; 17:1519-1528. PMID:21472114; DOI:10.3748/wjg.v17.i12.1519.
17. De Preter V, Hamer HM, Windey K, Verbeke K. The impact of pre- and/or probiotics on human colonic metabolism: does it affect human health? Mol Nutr Food Res 2011; 55:46-57. PMID:21207512; DOI:10.1002/mnfr.201000451.
18. Saltzman JR, Kowdlery KV, Perrone G, Russell RM. Changing in small-intestine permeability with aging. J Am Geriatr Soc 1995; 43:160-164. PMID:7836641.
19. He F, Ouwehand AC, Isolauri E, Hosoda M, Benno Y, Salminen S. D. Differences in composition and mucosal adhesion of bifidobacteria isolated from healthy adults and healthy seniors. Curr Microbiol 2001; 43:351-435. PMID:11688800; DOI:10.1007/s002840010315.
20. Thomas CM, Versalovic J. Probiotics-host communication. Modulation of signaling pathways in the intestine. Gut Microbes 2010; 1:148-163. PMID:20672012; DOI:10.4161/gmic.1.3.11712.
21. Lomax AR, Calder PC. Probiotics, immune function, infection and inflammation: a review of the evidence from studies conducted in humans. Curr Pharm Des 2009; 15:1428-518. PMID:19442167; DOI:10.2174/138161209788168155.
22. Majamaa H, Isolauri E. Probiotics: A novel approach in the management of food allergy. J Allergy Clin Immunol 1997; 99:179-185. PMID:9042042; DOI:10.1016/S0091-6749(97)70093-9.
23. Isolauri E, Kalliomäki M, Laitinen K, Salminen S. Modulation of the maturing gut barrier and microbiota: a novel target in allergic disease. Curr Pharm Des 2008; 14:1368-1375. PMID:18537659; DOI:10.2174/138161208784480207.
24. Ozdemir O. Various effects of different probiotic strains in allergic disorders: an update from laboratory and clinical data. Clin Exp Immunol 2010; 160:295-304. PMID:20345982; DOI:10.1111/j.1365- 2249.2010.04109.x.
25. Shane AL, Cabana MD, Vidry S, Merenstein D, Hummelen R, Ellis CL, et al. Guide to designing, conducting, publishing and communicating results of clinical studies involving probiotic applications in human participants. Gut Microbes 2010; 1:243-253. PMID:21327031; DOI:10.4161/gmic.1.4.12707.
26. Doron SI, Hibberd PL, Gorbach SL. Probiotics for prevention of antibiotic-associated diarrhea. J Clin Gastroenterol 2008; 42:58-63. PMID:18542041; DOI:10.1097/MCG.0b013e3181618ab7.
27. Kale-Pradhan PB, Jassal HK, Wilhelm SM. Role of Lactobacillus in the prevention of antibiotic-associated diarrhea: a meta-analysis. Pharmacotherapy 2010; 30:119-126. PMID:20099986; DOI:10.1592/phco.30.2.119.
28. Meerpohl JJ, Timmer A. News from the Cochrane Library: probiotics for the prevention of paediatric antibiotic-associated diarrhoea. Z Gastroenterol 2007; 45:715-717. PMID:17701862; DOI:10.1055/s-2007-963352.
29. McFarland LV. Systematic review and meta-analysis of Saccharomyces boulardii in adult patients. World J Gastroenterol 2010; 16:2202-2222. PMID:20458757; DOI:10.3748/wjg.v16.i18.2202.
30. Willett W. Nutritional Epidemiology. Second edition ed. New York, NY: Oxfor University Press 1998.
31. Biró G, Hulshof KF, Ovesen L, Amorim Cruz JA. Selection of methodology to assess food intake. Eur J Clin Nutr 2002; 56:25-32. PMID:12082515; DOI:10.1038/sj.ejcn.1601426.
32. Kipnis V, Midthune D, Freedman L, Bingham S, Day NE, Riboli E, et al. Bias in dietary-report instruments and its implications for nutritional epidemiology. Public Health Nutr 2002; 5:915-923. MID:12633516; DOI:10.1079/PHN2002383.
33. Barrett B, Brown RL, Mundt MP, Thomas GR, Barlow SK, Highstrom AD, et al. Validation of a short form Wisconsin Upper Respiratory Symptom Survey (WURSS-21). Health Qual Life Outcomes 2009; 7:76. PMID:19674476; DOI:10.1186/1477-7525-7-76.
34. Agachan F, Chen T, Pfeifer J, Reissman P, Wexner SD. A constipation scoring system to simplify evaluation and management of constipated patients. Dis Colon Rectum 39:681-685. PMID:8646957; DOI:10.1007/ BF02056950.
35. Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol 1997; 32:920-924. PMID:9299672; DOI:10.3109/00365529709011203.
36. Wiklund IK, Fulleron S, Hawkey CJ, Jones RH, Longstreth GF, Mayer EA, et al. An irritable bowel- specific symptom questionnaire: development and validation. Scand J Gastroenterol 2003; 38:947-954. PMID:14531531; DOI:10.1080/00365520310004209.
37. Chassany O, Marquis P, Scherrer B, Read NW, Finger T, Bergmann JF, et al. Validation of a specific quality of life questionnaire for functional digestive disorders. Gut 1999; 44:527-533. PMID:10075960; DOI:10.1136/gut.44.4.527.
38. Karczewski J, Troost FJ, Konings I, Dekker J, Kleerebezem M, Brummer RJ, et al. Regulation of human epithelial tight junction proteins by Lactobacillus plantarum in vivo and protective effects on the epithelial barrier. Am J Physiol Gastrointest Liver Physiol 2010; 298:851-859. PMID:20224007; DOI:10.1152/ajpgi.00327.2009.
39. Ramakrishna BS. Probiotic-induced changes in the intestinal epithelium: implications in gastrointestinal disease. Trop Gastroenterol 2009; 30:76-85. PMID:19760989.
40. Montalto M, Maggiano N, Ricci R, Curigliano V, Santoro L, Di Nicuolo F, et al. Lactobacillus acidophilus protects tight junctions from aspirin damage in HT-29 cells. Digestion 2004; 69:225-228. PMID:15205571; DOI:10.1159/000079152.
41. Allen SJ, Martinez EG, Gregorio GV, Dans LF. Probiotics for treating acute infectious diarrhoea. Cochrane Database Syst Rev 2010; 11:3048. PMID:21069673.
42. McFarland LV. Meta-analysis of probiotics for the prevention of traveler's diarrhea. Travel Med Infect Dis 2007; 97-105. PMID:17298915; DOI:10.1016/j. tmaid.2005.10.003.
43. de Vrese M, Winkler P, Rautenberg P, Harder T, Noah C, Laue C, et al. Probiotic bacteria reduced duration and severity but not the incidence of common cold episodes in a double blind, randomized, controlled trial. Vaccine 2006; 24:6670-6674. PMID:16844267; DOI:10.1016/j.vaccine.2006.05.048
44. EFSA Panel on Dietetic Products. Nutrition and Allergies (NDA): Scientific Opinion on the substantiation of a health claim related to Immunofortis® and strengthening of the baby's immune system. EFSA J 2010; 8:1430.