Clinical trial NCT03150927 - References

Quality of Life — Clinical Study of Novel Probiotic Microbial Composite™ to Treat Undernourished Young Children

Citation(s)

•   Allen SJ, Okoko B, Martinez E, Gregorio G, Dans LF
  Probiotics for treating infectious diarrhoea. Cochrane Database Syst Rev. 2004;(2):CD003048. Review. Update in: Cochrane Database Syst Rev. 2010;(11):CD003048.
•   Asuzu MC
  A comparative study of the commonly used nutritional assessment tools for primary health care. East Afr Med J. 1991 Nov;68(11):913-22.
•   Bhutta ZA, Das JK
  Interventions to address maternal and childhood undernutrition: current evidence. Nestle Nutr Inst Workshop Ser. 2014;78:59-69. doi: 10.1159/000354941. Epub 2014 Jan 27. Review.
•   Borody TJ, Peattie D, Kapur A
  Could fecal microbiota transplantation cure all Clostridium difficile infections? Future Microbiol. 2014;9(1):1-3. doi: 10.2217/fmb.13.146.
•   Canani RB, Cirillo P, Terrin G, Cesarano L, Spagnuolo MI, De Vincenzo A, Albano F, Passariello A, De Marco G, Manguso F, Guarino A
  Probiotics for treatment of acute diarrhoea in children: randomised clinical trial of five different preparations. BMJ. 2007 Aug 18;335(7615):340. Epub 2007 Aug 9.
•   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. Review.
•   Cunliffe NA, Kilgore PE, Bresee JS, Steele AD, Luo N, Hart CA, Glass RI
  Epidemiology of rotavirus diarrhoea in Africa: a review to assess the need for rotavirus immunization. Bull World Health Organ. 1998;76(5):525-37. Review.
•   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. Review.
•   Dabek M, McCrae SI, Stevens VJ, Duncan SH, Louis P
  Distribution of beta-glucosidase and beta-glucuronidase activity and of beta-glucuronidase gene gus in human colonic bacteria. FEMS Microbiol Ecol. 2008 Dec;66(3):487-95. doi: 10.1111/j.1574-6941.2008.00520.x. Epub 2008 Jun 4.
•   Depeint F, Tzortzis G, Vulevic J, I'anson K, Gibson GR
  Prebiotic evaluation of a novel galactooligosaccharide mixture produced by the enzymatic activity of Bifidobacterium bifidum NCIMB 41171, in healthy humans: a randomized, double-blind, crossover, placebo-controlled intervention study. Am J Clin Nutr. 2008 Mar;87(3):785-91.
•   Dubey AP, Rajeshwari K, Chakravarty A, Famularo G
  Use of VSL[sharp]3 in the treatment of rotavirus diarrhea in children: preliminary results. J Clin Gastroenterol. 2008 Sep;42 Suppl 3 Pt 1:S126-9. doi: 10.1097/MCG.0b013e31816fc2f6.
•   Fang SB, Lee HC, Hu JJ, Hou SY, Liu HL, Fang HW
  Dose-dependent effect of Lactobacillus rhamnosus on quantitative reduction of faecal rotavirus shedding in children. J Trop Pediatr. 2009 Oct;55(5):297-301. doi: 10.1093/tropej/fmp001. Epub 2009 Feb 8.
•   Grönlund MM, Lehtonen OP, Eerola E, Kero P
  Fecal microflora in healthy infants born by different methods of delivery: permanent changes in intestinal flora after cesarean delivery. J Pediatr Gastroenterol Nutr. 1999 Jan;28(1):19-25.
•   Grosse SD, Roy K
  Long-term economic effect of early childhood nutrition. Lancet. 2008 Feb 2;371(9610):365-6. doi: 10.1016/S0140-6736(08)60180-4.
•   Guarino A, Canani RB, Spagnuolo MI, Albano F, Di Benedetto L
  Oral bacterial therapy reduces the duration of symptoms and of viral excretion in children with mild diarrhea. J Pediatr Gastroenterol Nutr. 1997 Nov;25(5):516-9.
•   Gueimonde M, Sakata S, Kalliomäki M, Isolauri E, Benno Y, Salminen S
  Effect of maternal consumption of lactobacillus GG on transfer and establishment of fecal bifidobacterial microbiota in neonates. J Pediatr Gastroenterol Nutr. 2006 Feb;42(2):166-70.
•   Hapfelmeier S, Lawson MA, Slack E, Kirundi JK, Stoel M, Heikenwalder M, Cahenzli J, Velykoredko Y, Balmer ML, Endt K, Geuking MB, Curtiss R 3rd, McCoy KD, Macpherson AJ
  Reversible microbial colonization of germ-free mice reveals the dynamics of IgA immune responses. Science. 2010 Jun 25;328(5986):1705-9. doi: 10.1126/science.1188454.
•   Hoddinott J, Maluccio JA, Behrman JR, Flores R, Martorell R
  Effect of a nutrition intervention during early childhood on economic productivity in Guatemalan adults. Lancet. 2008 Feb 2;371(9610):411-6. doi: 10.1016/S0140-6736(08)60205-6.
•   Hooper LV, Midtvedt T, Gordon JI
  How host-microbial interactions shape the nutrient environment of the mammalian intestine. Annu Rev Nutr. 2002;22:283-307. Epub 2002 Apr 4. Review.
•   International Conference on Primary Health Care
  . Declaration of Alma-Ata. WHO Chron. 1978 Nov;32(11):428-30.
•   Johnson CL, Versalovic J
  The human microbiome and its potential importance to pediatrics. Pediatrics. 2012 May;129(5):950-60. doi: 10.1542/peds.2011-2736. Epub 2012 Apr 2. Review.
•   Johnston BC, Supina AL, Ospina M, Vohra S
  Probiotics for the prevention of pediatric antibiotic-associated diarrhea. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD004827. Review. Update in: Cochrane Database Syst Rev. 2011;(11):CD004827.
•   Kalliomäki M, Salminen S, Poussa T, Isolauri E
  Probiotics during the first 7 years of life: a cumulative risk reduction of eczema in a randomized, placebo-controlled trial. J Allergy Clin Immunol. 2007 Apr;119(4):1019-21. Epub 2007 Feb 7.
•   Kawamoto S, Tran TH, Maruya M, Suzuki K, Doi Y, Tsutsui Y, Kato LM, Fagarasan S
  The inhibitory receptor PD-1 regulates IgA selection and bacterial composition in the gut. Science. 2012 Apr 27;336(6080):485-9. doi: 10.1126/science.1217718.
•   Kosek M, Bern C, Guerrant RL
  The global burden of diarrhoeal disease, as estimated from studies published between 1992 and 2000. Bull World Health Organ. 2003;81(3):197-204. Epub 2003 May 16. Review.
•   Laparra JM, Sanz Y
  Comparison of in vitro models to study bacterial adhesion to the intestinal epithelium. Lett Appl Microbiol. 2009 Dec;49(6):695-701. doi: 10.1111/j.1472-765X.2009.02729.x. Epub 2009 Aug 25.
•   Laparra JM, Sanz Y
  Interactions of gut microbiota with functional food components and nutraceuticals. Pharmacol Res. 2010 Mar;61(3):219-25. doi: 10.1016/j.phrs.2009.11.001. Epub 2009 Nov 13. Review.
•   Lefkovitz AL, Zarowitz BJ
  It's a microscopic world after all: prebiotics, probiotics, and synbiotics. Geriatr Nurs. 2013 Jul-Aug;34(4):323-5. doi: 10.1016/j.gerinurse.2013.06.007.
•   Marteau P, Shanahan F
  Basic aspects and pharmacology of probiotics: an overview of pharmacokinetics, mechanisms of action and side-effects. Best Pract Res Clin Gastroenterol. 2003 Oct;17(5):725-40. Review.
•   Mountzouris KC, McCartney AL, Gibson GR
  Intestinal microflora of human infants and current trends for its nutritional modulation. Br J Nutr. 2002 May;87(5):405-20. Review.
•   Owen GM
  The new National Center for Health Statistics growth charts. South Med J. 1978 Mar;71(3):296-7.
•   Patel RM, Denning PW
  Therapeutic use of prebiotics, probiotics, and postbiotics to prevent necrotizing enterocolitis: what is the current evidence? Clin Perinatol. 2013 Mar;40(1):11-25. doi: 10.1016/j.clp.2012.12.002. Epub 2013 Jan 17. Review.
•   Pedone CA, Arnaud CC, Postaire ER, Bouley CF, Reinert P
  Multicentric study of the effect of milk fermented by Lactobacillus casei on the incidence of diarrhoea. Int J Clin Pract. 2000 Nov;54(9):568-71.
•   Pedone CA, Bernabeu AO, Postaire ER, Bouley CF, Reinert P
  The effect of supplementation with milk fermented by Lactobacillus casei (strain DN-114 001) on acute diarrhoea in children attending day care centres. Int J Clin Pract. 1999 Apr-May;53(3):179-84.
•   Rautava S, Arvilommi H, Isolauri E
  Specific probiotics in enhancing maturation of IgA responses in formula-fed infants. Pediatr Res. 2006 Aug;60(2):221-4.
•   Ruemmele FM, Bier D, Marteau P, Rechkemmer G, Bourdet-Sicard R, Walker WA, Goulet O
  Clinical evidence for immunomodulatory effects of probiotic bacteria. J Pediatr Gastroenterol Nutr. 2009 Feb;48(2):126-41. doi: 10.1097/MPG.0b013e31817d80ca. Review.
•   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.
•   Sanz Y, De Palma G
  Gut microbiota and probiotics in modulation of epithelium and gut-associated lymphoid tissue function. Int Rev Immunol. 2009;28(6):397-413. doi: 10.3109/08830180903215613. Review.
•   Schoeman SE, Hendricks MK, Hattingh SP, Benadé AJ, Laubscher JA, Dhansay MA
  The targeting of nutritionally at-risk children attending a primary health care facility in the Western Cape Province of South Africa. Public Health Nutr. 2006 Dec;9(8):1007-12.
•   Schwiertz A, Gruhl B, Löbnitz M, Michel P, Radke M, Blaut M
  Development of the intestinal bacterial composition in hospitalized preterm infants in comparison with breast-fed, full-term infants. Pediatr Res. 2003 Sep;54(3):393-9. Epub 2003 Jun 4.
•   Shanahan F
  Probiotics: a perspective on problems and pitfalls. Scand J Gastroenterol Suppl. 2003;(237):34-6. Review.
•   Szajewska H, Mrukowicz J
  Meta-analysis: non-pathogenic yeast Saccharomyces boulardii in the prevention of antibiotic-associated diarrhoea. Aliment Pharmacol Ther. 2005 Sep 1;22(5):365-72. Review.
•   Szajewska H, Ruszczynski M, Radzikowski A
  Probiotics in the prevention of antibiotic-associated diarrhea in children: a meta-analysis of randomized controlled trials. J Pediatr. 2006 Sep;149(3):367-372.
•   Szajewska H, Skórka A, Dylag M
  Meta-analysis: Saccharomyces boulardii for treating acute diarrhoea in children. Aliment Pharmacol Ther. 2007 Feb 1;25(3):257-64. Erratum in: Aliment Pharmacol Ther. 2009 Apr;29(7):800.
•   Tlaskalová-Hogenová H, Stepánková R, Hudcovic T, Tucková L, Cukrowska B, Lodinová-Zádníková R, Kozáková H, Rossmann P, Bártová J, Sokol D, Funda DP, Borovská D, Reháková Z, Sinkora J, Hofman J, Drastich P, Kokesová A
  Commensal bacteria (normal microflora), mucosal immunity and chronic inflammatory and autoimmune diseases. Immunol Lett. 2004 May 15;93(2-3):97-108. Review.
•   Tsilingiri K, Rescigno M
  Postbiotics: what else? Benef Microbes. 2013 Mar 1;4(1):101-7. doi: 10.3920/BM2012.0046. Review.
•   van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ
  Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.
•   Weizman Z, Asli G, Alsheikh A
  Effect of a probiotic infant formula on infections in child care centers: comparison of two probiotic agents. Pediatrics. 2005 Jan;115(1):5-9.
•   Wingreen NS, Levin SA
  Cooperation among microorganisms. PLoS Biol. 2006 Sep;4(9):e299.
•   Zoetendal EG, Rajilic-Stojanovic M, de Vos WM
  High-throughput diversity and functionality analysis of the gastrointestinal tract microbiota. Gut. 2008 Nov;57(11):1605-15. doi: 10.1136/gut.2007.133603. Review.

A Clinical Study to Determine the Effects of a Novel Probiotic Microbial Composite™ on Improving Digestive Health and Key Growth Parameters in Undernourished Young Children

Details for clinical trial NCT03150927