BB-12 补充草莓酸奶对服用抗生素的健康成年人的安全性 (PHASE)
2013年5月17日 更新者：Daniel Merenstein、Georgetown University
我们相信，一种现成的含有高剂量益生菌的饮料有可能通过许多这些机制提高依从性。 该产品还有可能对全世界儿童和成人的健康产生积极影响，因为与药物类制剂相比，酸奶对儿童及其父母的长期消费可能更具吸引力。 除了与食用益生菌相关的益处外，食用酸奶这种营养丰富的食物还能带来更多的健康益处。
更具体地说，这项 I 期研究的基本原理是确定我们饮料的安全性并遵守 FDA 关于 IND 申请的建议，我们将进行 I 期安全性研究。
我们假设 BB-12 对 18 岁及以上的健康成年人是安全的。
研究概览
研究类型
介入性
注册 (实际的)
40
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
District of Columbia
-
Washington、District of Columbia、美国、20007
- Georgetown University Medical Center
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
纳入标准：
- 能够说和写英语或西班牙语
- 用于适当储存饮料的冰箱
- 电话接入
- 登记必须在开始使用抗生素后 24 小时内进行
- 用青霉素类抗生素治疗上呼吸道感染 10 天；
以下是包含抗生素的清单：
- 阿莫西林
- 奥格门汀（阿莫西林/克拉维酸）
- Ancef（头孢唑林）
- 头孢羟氨苄
- 头孢氨苄
- 头孢拉定
- Duricef（头孢羟氨苄）
- Keflex（头孢氨苄）
- Kefzol（头孢唑林）
- Velosef（头孢拉定）
- 头孢克洛（cefaclor）
- 头孢坦
- 头孢西丁
- 头孢呋辛（cefuroxime）
- 头孢丙烯（cefprozil）
- 劳拉比德 (loracarbef)
- 美福新（头孢西丁）
- Zinacef（头孢呋辛）
- Omnicef（头孢地尼）
- Suprax（头孢克肟）
- 双氯西林
Pen-Vee K（青霉素）
- 每天至少开两次抗生素
- 门诊病人
排除标准：
- 需要每日服药的慢性病，例如糖尿病或哮喘
- 草莓过敏
- 活动性腹泻
- 对青霉素类抗生素过敏
- 除处方抗生素和退热药外使用的任何其他药物
对以下任何药物过敏
- 四环素
- 红霉素
- 甲氧苄啶
- 环丙沙星
- 乳糖不耐症。
- 在基线体检期间，以下任何一项将被排除在外；收缩压>140，收缩压<90，舒张压>90，氧饱和度<98%，脉率>100，脉率<55，呼吸频率>17。 这些包括所有超出“正常”范围的生命体征，包括 1 级到 4 级。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：1.主动
动物双歧杆菌亚种 乳酸菌（B. 乳球菌）菌株 BB-12 (BB-12) 益生菌，BB-12，补充酸奶，4 盎司，口服 10 天 |
动物双歧杆菌亚种
乳酸菌（B.
lactis) 菌株 BB-12 (BB-12) 补充益生菌的酸奶，4 盎司，口服 10 天
其他名称：
|
|
安慰剂比较：2. 安慰剂
草莓味酸奶
|
草莓味酸奶
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
主要结果是评估一般健康且服用抗生素的成年人食用 BB-12 酸奶的安全性。
大体时间：1年
|
1年
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
除了安全日记外，参与者还将每天记日记以跟踪排便次数、是否饮酒、是否因疾病导致活动改变、使用的非处方药和其他疾病症状。
大体时间：1年
|
1年
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- D'Souza AL, Rajkumar C, Cooke J, Bulpitt CJ. Probiotics in prevention of antibiotic associated diarrhoea: meta-analysis. BMJ. 2002 Jun 8;324(7350):1361. doi: 10.1136/bmj.324.7350.1361.
- Cremonini F, Di Caro S, Nista EC, Bartolozzi F, Capelli G, Gasbarrini G, Gasbarrini A. Meta-analysis: the effect of probiotic administration on antibiotic-associated diarrhoea. Aliment Pharmacol Ther. 2002 Aug;16(8):1461-7. doi: 10.1046/j.1365-2036.2002.01318.x.
- Winnick S, Lucas DO, Hartman AL, Toll D. How do you improve compliance? Pediatrics. 2005 Jun;115(6):e718-24. doi: 10.1542/peds.2004-1133.
- Bartosch S, Woodmansey EJ, Paterson JC, McMurdo ME, Macfarlane GT. Microbiological effects of consuming a synbiotic containing Bifidobacterium bifidum, Bifidobacterium lactis, and oligofructose in elderly persons, determined by real-time polymerase chain reaction and counting of viable bacteria. Clin Infect Dis. 2005 Jan 1;40(1):28-37. doi: 10.1086/426027. Epub 2004 Dec 6.
- Saavedra JM, Bauman NA, Oung I, Perman JA, Yolken RH. Feeding of Bifidobacterium bifidum and Streptococcus thermophilus to infants in hospital for prevention of diarrhoea and shedding of rotavirus. Lancet. 1994 Oct 15;344(8929):1046-9. doi: 10.1016/s0140-6736(94)91708-6.
- Kalliomaki M, Salminen S, Arvilommi H, Kero P, Koskinen P, Isolauri E. Probiotics in primary prevention of atopic disease: a randomised placebo-controlled trial. Lancet. 2001 Apr 7;357(9262):1076-9. doi: 10.1016/S0140-6736(00)04259-8.
- Salminen S, von Wright A, Morelli L, Marteau P, Brassart D, de Vos WM, Fonden R, Saxelin M, Collins K, Mogensen G, Birkeland SE, Mattila-Sandholm T. Demonstration of safety of probiotics -- a review. Int J Food Microbiol. 1998 Oct 20;44(1-2):93-106. doi: 10.1016/s0168-1605(98)00128-7.
- Gionchetti P, Rizzello F, Helwig U, Venturi A, Lammers KM, Brigidi P, Vitali B, Poggioli G, Miglioli M, Campieri M. Prophylaxis of pouchitis onset with probiotic therapy: a double-blind, placebo-controlled trial. Gastroenterology. 2003 May;124(5):1202-9. doi: 10.1016/s0016-5085(03)00171-9.
- McCaig LF, Besser RE, Hughes JM. Antimicrobial drug prescription in ambulatory care settings, United States, 1992-2000. Emerg Infect Dis. 2003 Apr;9(4):432-7. doi: 10.3201/eid0904.020268. Erratum In: Emerg Infect Dis. 2003 May;9(5):609.
- McCaig LF, Hughes JM. Trends in antimicrobial drug prescribing among office-based physicians in the United States. JAMA. 1995 Jan 18;273(3):214-9. Erratum In: JAMA 1998 Feb 11;279(6):434.
- Isolauri E, Arvola T, Sutas Y, Moilanen E, Salminen S. Probiotics in the management of atopic eczema. Clin Exp Allergy. 2000 Nov;30(11):1604-10. doi: 10.1046/j.1365-2222.2000.00943.x.
- McFarland LV. Meta-analysis of probiotics for the prevention of antibiotic associated diarrhea and the treatment of Clostridium difficile disease. Am J Gastroenterol. 2006 Apr;101(4):812-22. doi: 10.1111/j.1572-0241.2006.00465.x.
- Gionchetti P, Rizzello F, Venturi A, Brigidi P, Matteuzzi D, Bazzocchi G, Poggioli G, Miglioli M, Campieri M. Oral bacteriotherapy as maintenance treatment in patients with chronic pouchitis: a double-blind, placebo-controlled trial. Gastroenterology. 2000 Aug;119(2):305-9. doi: 10.1053/gast.2000.9370.
- Vanderhoof JA, Whitney DB, Antonson DL, Hanner TL, Lupo JV, Young RJ. Lactobacillus GG in the prevention of antibiotic-associated diarrhea in children. J Pediatr. 1999 Nov;135(5):564-8. doi: 10.1016/s0022-3476(99)70053-3.
- Sartor RB. Probiotic therapy of intestinal inflammation and infections. Curr Opin Gastroenterol. 2005 Jan;21(1):44-50.
- Heath and Nutritional Properties of Probiotics in Food Including Powder Milk With Live Lactic Acid Bacteria: Food and Agriculture Organization of the United Nations and World Health Organization2005; 2001.
- Lin HC, Su BH, Chen AC, Lin TW, Tsai CH, Yeh TF, Oh W. Oral probiotics reduce the incidence and severity of necrotizing enterocolitis in very low birth weight infants. Pediatrics. 2005 Jan;115(1):1-4. doi: 10.1542/peds.2004-1463.
- Mastrandrea F, Coradduzza G, Serio G, Minardi A, Manelli M, Ardito S, Muratore L. Probiotics reduce the CD34+ hemopoietic precursor cell increased traffic in allergic subjects. Eur Ann Allergy Clin Immunol. 2004 Apr;36(4):118-22.
- Rosenfeldt V, Michaelsen KF, Jakobsen M, Larsen CN, Moller PL, Pedersen P, Tvede M, Weyrehter H, Valerius NH, Paerregaard A. Effect of probiotic Lactobacillus strains in young children hospitalized with acute diarrhea. Pediatr Infect Dis J. 2002 May;21(5):411-6. doi: 10.1097/00006454-200205000-00012.
- Pelletier S, Kundrat S, Hasler CM. Effects of a functional foods nutrition education program with cardiac rehabilitation patients. J Cardiopulm Rehabil. 2003 Sep-Oct;23(5):334-40. doi: 10.1097/00008483-200309000-00002.
- Pelletier S, Kundrat S, Hasler CM. Effects of an educational program on intent to consume functional foods. J Am Diet Assoc. 2002 Sep;102(9):1297-300. doi: 10.1016/s0002-8223(02)90286-5.
- Hasler CM, Bloch AS, Thomson CA, Enrione E, Manning C. Position of the American Dietetic Association: Functional foods. J Am Diet Assoc. 2004 May;104(5):814-26. doi: 10.1016/j.jada.2004.03.015.
- Van den Driessche M, Veereman-Wauters G. Functional foods in pediatrics. Acta Gastroenterol Belg. 2002 Jan-Mar;65(1):45-51.
- Research MM. The Live Active Culture Yogurt Survey. Monroe Mendelsohn Research. Available at: http://www.dannon.com/dn/dnstore/cgi-bin/ProdDetEv_Cat_240861_SubCat_240857_NavRoot_200_NavID_241709_ProdID_289256.htm. Accessed May 24, 2005.
- Tuohy KM, Rouzaud GC, Bruck WM, Gibson GR. Modulation of the human gut microflora towards improved health using prebiotics--assessment of efficacy. Curr Pharm Des. 2005;11(1):75-90. doi: 10.2174/1381612053382331.
- Veilleux BG, Rowland I. Simulation of the rat intestinal ecosystem using a two-stage continuous culture system. J Gen Microbiol. 1981 Mar;123(1):103-15. doi: 10.1099/00221287-123-1-103.
- Clausen MR, Bonnen H, Tvede M, Mortensen PB. Colonic fermentation to short-chain fatty acids is decreased in antibiotic-associated diarrhea. Gastroenterology. 1991 Dec;101(6):1497-504. doi: 10.1016/0016-5085(91)90384-w.
- Engelbrektson AL, Korzenik JR, Sanders ME, Clement BG, Leyer G, Klaenhammer TR, Kitts CL. Analysis of treatment effects on the microbial ecology of the human intestine. FEMS Microbiol Ecol. 2006 Aug;57(2):239-50. doi: 10.1111/j.1574-6941.2006.00112.x.
- Klijn A, Mercenier A, Arigoni F. Lessons from the genomes of bifidobacteria. FEMS Microbiol Rev. 2005 Aug;29(3):491-509. doi: 10.1016/j.femsre.2005.04.010.
- Langhendries JP, Detry J, Van Hees J, Lamboray JM, Darimont J, Mozin MJ, Secretin MC, Senterre J. Effect of a fermented infant formula containing viable bifidobacteria on the fecal flora composition and pH of healthy full-term infants. J Pediatr Gastroenterol Nutr. 1995 Aug;21(2):177-81. doi: 10.1097/00005176-199508000-00009.
- Meile L, Ludwig W, Rueger U, et al. Bifidobacterium lactis sp. nov., a moderately oxygen tolerant species isolated from fermented milk. Syst. Appl. Microbiol. 1997(20):57-46.
- Fuller R. Probiotics in human medicine. Gut. 1991 Apr;32(4):439-42. doi: 10.1136/gut.32.4.439. No abstract available.
- Perdigon G, de Macias ME, Alvarez S, Oliver G, de Ruiz Holgado AA. Effect of perorally administered lactobacilli on macrophage activation in mice. Infect Immun. 1986 Aug;53(2):404-10. doi: 10.1128/iai.53.2.404-410.1986.
- Wilson KH, Perini F. Role of competition for nutrients in suppression of Clostridium difficile by the colonic microflora. Infect Immun. 1988 Oct;56(10):2610-4. doi: 10.1128/iai.56.10.2610-2614.1988.
- Pongpech P, Hentges DJ, Marsh WW, Eberle ME. Effect of streptomycin administration on association of enteric pathogens with cecal tissue of mice. Infect Immun. 1989 Jul;57(7):2092-7. doi: 10.1128/iai.57.7.2092-2097.1989.
- Sartor RB. Therapeutic manipulation of the enteric microflora in inflammatory bowel diseases: antibiotics, probiotics, and prebiotics. Gastroenterology. 2004 May;126(6):1620-33. doi: 10.1053/j.gastro.2004.03.024.
- Davidson JN, Hirsh DC. Bacterial competition as a means of preventing neonatal diarrhea in pigs. Infect Immun. 1976 Jun;13(6):1773-4. doi: 10.1128/iai.13.6.1773-1774.1976.
- Cong Y, Konrad A, Iqbal N, Elson CO. Probiotics and immune regulation of inflammatory bowel diseases. Curr Drug Targets Inflamm Allergy. 2003 Jun;2(2):145-54. doi: 10.2174/1568010033484278.
- Rautava S, Kalliomaki M, Isolauri E. Probiotics during pregnancy and breast-feeding might confer immunomodulatory protection against atopic disease in the infant. J Allergy Clin Immunol. 2002 Jan;109(1):119-21. doi: 10.1067/mai.2002.120273.
- Jijon H, Backer J, Diaz H, Yeung H, Thiel D, McKaigney C, De Simone C, Madsen K. DNA from probiotic bacteria modulates murine and human epithelial and immune function. Gastroenterology. 2004 May;126(5):1358-73. doi: 10.1053/j.gastro.2004.02.003.
- Kruis W, Fric P, Pokrotnieks J, Lukas M, Fixa B, Kascak M, Kamm MA, Weismueller J, Beglinger C, Stolte M, Wolff C, Schulze J. Maintaining remission of ulcerative colitis with the probiotic Escherichia coli Nissle 1917 is as effective as with standard mesalazine. Gut. 2004 Nov;53(11):1617-23. doi: 10.1136/gut.2003.037747.
- Kruis W, Schutz E, Fric P, Fixa B, Judmaier G, Stolte M. Double-blind comparison of an oral Escherichia coli preparation and mesalazine in maintaining remission of ulcerative colitis. Aliment Pharmacol Ther. 1997 Oct;11(5):853-8. doi: 10.1046/j.1365-2036.1997.00225.x.
- Rembacken BJ, Snelling AM, Hawkey PM, Chalmers DM, Axon AT. Non-pathogenic Escherichia coli versus mesalazine for the treatment of ulcerative colitis: a randomised trial. Lancet. 1999 Aug 21;354(9179):635-9. doi: 10.1016/s0140-6736(98)06343-0.
- Fukushima Y, Kawata Y, Hara H, Terada A, Mitsuoka T. Effect of a probiotic formula on intestinal immunoglobulin A production in healthy children. Int J Food Microbiol. 1998 Jun 30;42(1-2):39-44. doi: 10.1016/s0168-1605(98)00056-7.
- Fukushima Y, Kwata Y, H H. Effect of a probiotic formula containing bifidobacteria (Nan BF) on fecal flora and fecal metaboiltes in healthy children. Bioscience Microflora. 1997(16):65-72.
- Malinen E, Matto J, Salmitie M, Alander M, Saarela M, Palva A. PCR-ELISA II: Analysis of Bifidobacterium populations in human faecal samples from a consumption trial with Bifidobacterium lactis Bb-12 and a galacto-oligosaccharide preparation. Syst Appl Microbiol. 2002 Aug;25(2):249-58. doi: 10.1078/0723-2020-00117. Erratum In: Syst Appl Microbiol. 2003 Mar;26(1):154-5.
- Ouwehand AC, Kurvinen T, Rissanen P. Use of a probiotic Bifidobacterium in a dry food matrix, an in vivo study. Int J Food Microbiol. 2004 Aug 15;95(1):103-6. doi: 10.1016/j.ijfoodmicro.2004.03.015.
- Turck D, Bernet JP, Marx J, Kempf H, Giard P, Walbaum O, Lacombe A, Rembert F, Toursel F, Bernasconi P, Gottrand F, McFarland LV, Bloch K. Incidence and risk factors of oral antibiotic-associated diarrhea in an outpatient pediatric population. J Pediatr Gastroenterol Nutr. 2003 Jul;37(1):22-6. doi: 10.1097/00005176-200307000-00004.
- Mitchell DK, Van R, Mason EH, Norris DM, Pickering LK. Prospective study of toxigenic Clostridium difficile in children given amoxicillin/clavulanate for otitis media. Pediatr Infect Dis J. 1996 Jun;15(6):514-9. doi: 10.1097/00006454-199606000-00008.
- McCarty JM, Phillips A, Wiisanen R. Comparative safety and efficacy of clarithromycin and amoxicillin/clavulanate in the treatment of acute otitis media in children. Pediatr Infect Dis J. 1993 Dec;12(12 Suppl 3):S122-7. doi: 10.1097/00006454-199312003-00006.
- Elstner CL, Lindsay AN, Book LS, Matsen JM. Lack of relationship of Clostridium difficile to antibiotic-associated diarrhea in children. Pediatr Infect Dis. 1983 Sep-Oct;2(5):364-6. doi: 10.1097/00006454-198309000-00006.
- McFarland LV. Epidemiology, risk factors and treatments for antibiotic-associated diarrhea. Dig Dis. 1998 Sep-Oct;16(5):292-307. doi: 10.1159/000016879.
- Beaugerie L, Flahault A, Barbut F, Atlan P, Lalande V, Cousin P, Cadilhac M, Petit JC; Study Group. Antibiotic-associated diarrhoea and Clostridium difficile in the community. Aliment Pharmacol Ther. 2003 Apr 1;17(7):905-12. doi: 10.1046/j.1365-2036.2003.01531.x.
- Young VB, Schmidt TM. Antibiotic-associated diarrhea accompanied by large-scale alterations in the composition of the fecal microbiota. J Clin Microbiol. 2004 Mar;42(3):1203-6. doi: 10.1128/JCM.42.3.1203-1206.2004.
- Finkelstein JA, Davis RL, Dowell SF, Metlay JP, Soumerai SB, Rifas-Shiman SL, Higham M, Miller Z, Miroshnik I, Pedan A, Platt R. Reducing antibiotic use in children: a randomized trial in 12 practices. Pediatrics. 2001 Jul;108(1):1-7. doi: 10.1542/peds.108.1.1.
- Finkelstein JA, Metlay JP, Davis RL, Rifas-Shiman SL, Dowell SF, Platt R. Antimicrobial use in defined populations of infants and young children. Arch Pediatr Adolesc Med. 2000 Apr;154(4):395-400. doi: 10.1001/archpedi.154.4.395.
- Nyquist AC, Gonzales R, Steiner JF, Sande MA. Antibiotic prescribing for children with colds, upper respiratory tract infections, and bronchitis. JAMA. 1998 Mar 18;279(11):875-7. doi: 10.1001/jama.279.11.875. Erratum In: JAMA 1998 Jun 3;279(21):1702.
- Stille CJ, Andrade SE, Huang SS, Nordin J, Raebel MA, Go AS, Chan KA, Finkelstein JA. Increased use of second-generation macrolide antibiotics for children in nine health plans in the United States. Pediatrics. 2004 Nov;114(5):1206-11. doi: 10.1542/peds.2004-0311.
- Szajewska H, Mrukowicz JZ. Use of probiotics in children with acute diarrhea. Paediatr Drugs. 2005;7(2):111-22. doi: 10.2165/00148581-200507020-00004.
- Szajewska H, Mrukowicz JZ. Probiotics in prevention of antibiotic-associated diarrhea: meta-analysis. J Pediatr. 2003 Jan;142(1):85. No abstract available.
- Hawrelak JA, Whitten DL, Myers SP. Is Lactobacillus rhamnosus GG effective in preventing the onset of antibiotic-associated diarrhoea: a systematic review. Digestion. 2005;72(1):51-6. doi: 10.1159/000087637. Epub 2005 Aug 18.
- Correa NB, Peret Filho LA, Penna FJ, Lima FM, Nicoli JR. A randomized formula controlled trial of Bifidobacterium lactis and Streptococcus thermophilus for prevention of antibiotic-associated diarrhea in infants. J Clin Gastroenterol. 2005 May-Jun;39(5):385-9. doi: 10.1097/01.mcg.0000159217.47419.5b.
- Arvola T, Laiho K, Torkkeli S, Mykkanen H, Salminen S, Maunula L, Isolauri E. Prophylactic Lactobacillus GG reduces antibiotic-associated diarrhea in children with respiratory infections: a randomized study. Pediatrics. 1999 Nov;104(5):e64. doi: 10.1542/peds.104.5.e64.
- Kim YI. Will mandatory folic acid fortification prevent or promote cancer? Am J Clin Nutr. 2004 Nov;80(5):1123-8. doi: 10.1093/ajcn/80.5.1123.
- Williams LJ, Rasmussen SA, Flores A, Kirby RS, Edmonds LD. Decline in the prevalence of spina bifida and anencephaly by race/ethnicity: 1995-2002. Pediatrics. 2005 Sep;116(3):580-6. doi: 10.1542/peds.2005-0592.
- Hasler CM. Functional foods: benefits, concerns and challenges-a position paper from the american council on science and health. J Nutr. 2002 Dec;132(12):3772-81. doi: 10.1093/jn/132.12.3772.
- Avery JK. Making the most of cholesterol-lowering margarines. Cleve Clin J Med. 2001 Mar;68(3):194-6. doi: 10.3949/ccjm.68.3.194.
- Tammi A, Ronnemaa T, Gylling H, Rask-Nissila L, Viikari J, Tuominen J, Pulkki K, Simell O. Plant stanol ester margarine lowers serum total and low-density lipoprotein cholesterol concentrations of healthy children: the STRIP project. Special Turku Coronary Risk Factors Intervention Project. J Pediatr. 2000 Apr;136(4):503-10. doi: 10.1016/s0022-3476(00)90014-3.
- Hasler CM. Functional Foods: Their Role in Diease Prevention and Health Promotion. Food Technology. 1998;52(2):57-62.
- Hasler CM, Kundrat S, Wool D. Functional foods and cardiovascular disease. Curr Atheroscler Rep. 2000 Nov;2(6):467-75. doi: 10.1007/s11883-000-0045-9.
- St-Onge MP. Dietary fats, teas, dairy, and nuts: potential functional foods for weight control? Am J Clin Nutr. 2005 Jan;81(1):7-15. doi: 10.1093/ajcn/81.1.7.
- Floch MH, Hong-Curtiss J. Probiotics and Functional Foods in Gastrointestinal Disorders. Curr Treat Options Gastroenterol. 2002 Aug;5(4):311-321. doi: 10.1007/s11938-002-0054-6.
- Hamilton-Miller JM, Shah S, Winkler JT. Public health issues arising from microbiological and labelling quality of foods and supplements containing probiotic microorganisms. Public Health Nutr. 1999 Jun;2(2):223-9. doi: 10.1017/s1368980099000282.
- Beniwal RS, Arena VC, Thomas L, Narla S, Imperiale TF, Chaudhry RA, Ahmad UA. A randomized trial of yogurt for prevention of antibiotic-associated diarrhea. Dig Dis Sci. 2003 Oct;48(10):2077-82. doi: 10.1023/a:1026155328638.
- Alm L, Ryd-Kjellen E, Setterberg G, Blomquist L. Effect of a new fermented milk product
- Black FT, Anderson PL, Orskov J, Orskov F, Gaarslev K, Laulund S. Prophylactic efficacy of lactobacilli on traveler's diarrhea. Travel Medicine. 1989:333-335.
- Chouraqui JP, Van Egroo LD, Fichot MC. Acidified milk formula supplemented with bifidobacterium lactis: impact on infant diarrhea in residential care settings. J Pediatr Gastroenterol Nutr. 2004 Mar;38(3):288-92. doi: 10.1097/00005176-200403000-00011.
- Phuapradit P, Varavithya W, Vathanophas K, Sangchai R, Podhipak A, Suthutvoravut U, Nopchinda S, Chantraruksa V, Haschke F. Reduction of rotavirus infection in children receiving bifidobacteria-supplemented formula. J Med Assoc Thai. 1999 Nov;82 Suppl 1:S43-8.
- Schiffrin EJ, Rochat F, Link-Amster H, Aeschlimann JM, Donnet-Hughes A. Immunomodulation of human blood cells following the ingestion of lactic acid bacteria. J Dairy Sci. 1995 Mar;78(3):491-7. doi: 10.3168/jds.S0022-0302(95)76659-0.
- Link-Amster H, Rochat F, Saudan KY, Mignot O, Aeschlimann JM. Modulation of a specific humoral immune response and changes in intestinal flora mediated through fermented milk intake. FEMS Immunol Med Microbiol. 1994 Nov;10(1):55-63. doi: 10.1111/j.1574-695X.1994.tb00011.x. Erratum In: FEMS Immunol Med Microbiol 1995 Dec;12(3-4):273. FEMS Immunol Med Microbiol 1995 Sep;12(1):83.
- Kankaanpaa P, Sutas Y, Salminen S, Isolauri E. Results on clinical demonstration of probiotics on children. Paper presented at: Presented at Functional Food Research in Europe, Third Workshop, 1998; Probdemo, Finland, October 1-2.
- Amrouche T, Boutin Y, Fliss I. Effects of bifidobacterial cytoplasm peptide and protein fractions on mouse lymphocyte proliferation and cytokine production. Food and Agricultural Immunology. MAR 2006;17(1):29-42.
- Amrouche T, Boutin Y, Prioult G, Fliss I. Effects of bifidobacterial cytoplasm, cell wall and exopolysaccharide on mouse lymphocyte proliferation and cytokine production. International Dairy Journal. JAN 2006;16(1):70-80.
- Matsumoto M, Ohishi H, Benno Y. Impact of LKM512 yogurt on improvement of intestinal environment of the elderly. FEMS Immunol Med Microbiol. 2001 Oct;31(3):181-6. doi: 10.1111/j.1574-695X.2001.tb00518.x.
- Obradovic D, Curic M, Ivanovic M, Trbojevic B, Djordjevic M. Probiotic function of the fermented milk Jogurt Plus. Paper presented at: FEMS Conference (Fifthe Symposium on Lactic Acid Bacteria), 1996; Holland. September 8-12.
- Nord CE, Lidbeck A, Orrhage K, Sjostedt S. Oral supplementation with lactic acid-producing bacteria during intake of clindamycin. Clin Microbiol Infect. 1997 Feb;3(1):124-132. doi: 10.1111/j.1469-0691.1997.tb00262.x.
- Salminen S, Laine M, von Wright A, Vuopio-Varkila J, Kohonen T, Mattila-Sandholm T. Development of selection criteria for probiotic strains to assess their potential in functional foods: A Nordic and European approach. Bioscience Microflora. 1996;15(2):61-67.
- Black FT, Laulund S. A study on the recovery of ingested, encapsulated Lactobacillus acidophilus and Bifidobacteria bifidum from doudenal fluid and faeces. Chr. Hansen Internal Report. 1988.
- Abi-Hanna A, Moore N, Yolken RH, Saavedra JM. Long term consumption of infant formulas with live probiotic bacteria: safety and tolerance. Journal of Pediatric Gastroenterology and Nutrition. 1998;27(4):484.
- Saavedra JM, Abi-Hanna A, Moore N, Yolken RH. Long-term consumption of infant formulas containing live probiotic bacteria: tolerance and safety. Am J Clin Nutr. 2004 Feb;79(2):261-7. doi: 10.1093/ajcn/79.2.261.
- Lourens-Hattingh A, Viljoen BC. Yogurt as probiotic carrier food. International Dairy Journal. 2001;11(1-2):1-17.
- Tammam JD, Williams AG, Banks J, Cowie G, Lloyd D. Membrane inlet mass spectrometric measurement of O2 and CO2 gradients in cultures of Lactobacillus paracasei and a developing Cheddar cheese ecosystem. Int J Food Microbiol. 2001 Apr 11;65(1-2):11-22. doi: 10.1016/s0168-1605(00)00438-4.
- Gonzales R, Steiner JF, Sande MA. Antibiotic prescribing for adults with colds, upper respiratory tract infections, and bronchitis by ambulatory care physicians. JAMA. 1997 Sep 17;278(11):901-4.
- Gill JM, Fleischut P, Haas S, Pellini B, Crawford A, Nash DB. Use of antibiotics for adult upper respiratory infections in outpatient settings: a national ambulatory network study. Fam Med. 2006 May;38(5):349-54.
- Steinman MA, Gonzales R, Linder JA, Landefeld CS. Changing use of antibiotics in community-based outpatient practice, 1991-1999. Ann Intern Med. 2003 Apr 1;138(7):525-33. doi: 10.7326/0003-4819-138-7-200304010-00008.
- Glass RI, Lew JF, Gangarosa RE, LeBaron CW, Ho MS. Estimates of morbidity and mortality rates for diarrheal diseases in American children. J Pediatr. 1991 Apr;118(4 Pt 2):S27-33. doi: 10.1016/s0022-3476(05)81422-2.
- Gangarosa RE, Glass RI, Lew JF, Boring JR. Hospitalizations involving gastroenteritis in the United States, 1985: the special burden of the disease among the elderly. Am J Epidemiol. 1992 Feb 1;135(3):281-90. doi: 10.1093/oxfordjournals.aje.a116282.
- Ho MS, Glass RI, Pinsky PF, Young-Okoh NC, Sappenfield WM, Buehler JW, Gunter N, Anderson LJ. Diarrheal deaths in American children. Are they preventable? JAMA. 1988 Dec 9;260(22):3281-5.
- Ho MS, Glass RI, Pinsky PF, Anderson LJ. Rotavirus as a cause of diarrheal morbidity and mortality in the United States. J Infect Dis. 1988 Nov;158(5):1112-6. doi: 10.1093/infdis/158.5.1112. No abstract available.
- Haynes RB, Yao X, Degani A, Kripalani S, Garg A, McDonald HP. Interventions to enhance medication adherence. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD000011. doi: 10.1002/14651858.CD000011.pub2.
- Ansah EK, Gyapong JO, Agyepong IA, Evans DB. Improving adherence to malaria treatment for children: the use of pre-packed chloroquine tablets vs. chloroquine syrup. Trop Med Int Health. 2001 Jul;6(7):496-504. doi: 10.1046/j.1365-3156.2001.00740.x.
- Nevins TE.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年10月1日
初级完成 (实际的)
2011年7月1日
研究完成 (实际的)
2011年7月1日
研究注册日期
首次提交
2009年2月18日
首先提交符合 QC 标准的
2009年2月19日
首次发布 (估计)
2009年2月20日
研究记录更新
最后更新发布 (估计)
2013年5月20日
上次提交的符合 QC 标准的更新
2013年5月17日
最后验证
2013年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.