Probiotics to improve outcomes of colic in the community: Protocol for the Baby Biotics randomised controlled trial

BMC Pediatrics

Volumn 12, Issue , 2012, Pages

  Sung, Valerie ^a,b,c   Hiscock, Harriet ^a,b,c   Tang, Mimi ^a,b,c   Mensah, Fiona K ^a,b,c   Heine, Ralf G ^a,b,c   Stock, Amanda ^a   York, Elissa ^a,b   Barr, Ronald G ^d   Wake, Melissa ^a,b,c  

^a ROYAL CHILDREN'S HOSPITAL   (Australia)

^b MURDOCH CHILDREN'S RESEARCH INSTITUTE   (Australia)

^c UNIVERSITY OF MELBOURNE   (Australia)

^d BC CHILDREN S HOSPITAL   (Canada)

Author keywords

Biota; Colic; Crying; Health care costs; Infant; Mental health; Postpartum depression; Probiotics; Quality of life; Randomised controlled trial

Indexed keywords

CALGRANULIN; PLACEBO; PROBIOTIC AGENT;

ARTICLE; COLIC; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; CRYING; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; ESCHERICHIA COLI; FECES LEVEL; FECES MICROFLORA; HUMAN; INFANT; LACTOBACILLUS REUTERI; MAJOR CLINICAL STUDY; PHASE 3 CLINICAL TRIAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; SLEEP TIME; TREATMENT OUTCOME;

COLIC; DOUBLE-BLIND METHOD; HUMANS; INFANT; PROBIOTICS; TREATMENT OUTCOME;

EID: 84865406205     PISSN: None     EISSN: 14712431     Source Type: Journal    
DOI: 10.1186/1471-2431-12-135     Document Type: Article

References (77)

1. Wessel MA, Cobb JC, Jackson EB, Harris GS, Detwiler AC. Paroxysmal fussing in infancy, sometimes called "colic". Pediatrics 1954, 14:421-434.
2. Lucassen PL, Assendelft WJ, van Eijk JT, Gubbels JW, Douwes AC, van Geldrop WJ. Systematic review of the occurrence of infantile colic in the community. Arch Dis Child 2001, 84:398-403. 10.1136/adc.84.5.398, 1718751, 11316682.
3. Wake M, Morton-Allen E, Poulakis Z, Hiscock H, Gallagher S, Oberklaid F. Prevalence, stability, and outcomes of cry-fuss and sleep problems in the first 2 years of life: prospective community-based study. Pediatrics 2006, 117:836-842. 10.1542/peds.2005-0775, 16510665.
4. Morris S, James-Roberts IS, Sleep J, Gillham P. Economic evaluation of strategies for managing crying and sleeping problems. Arch Dis Child 2001, 84:15-19. 10.1136/adc.84.1.15, 1718606, 11124777.
5. McMahon C, Barnett B, Kowalenko N, Tennant C, Don N. Postnatal depression, anxiety and unsettled infant behaviour. Aust N Z J Psychiatry 2001, 35:581-588. 10.1080/0004867010060505, 11551272.
6. Smart J, Hiscock H. Early infant crying and sleeping problems: a pilot study of impact on parental well-being and parent-endorsed strategies for management. J Paediatr Child Health 2007, 43:284-290. 10.1111/j.1440-1754.2007.01060.x, 17444831.
7. Barr RG, Trent RB, Cross J. Age-related incidence curve of hospitalized Shaken Baby Syndrome cases: convergent evidence for crying as a trigger to shaking.[see comment]. Child Abuse Negl 2006, 30:7-16. 10.1016/j.chiabu.2005.06.009, 16406023.
8. Lee C, Barr RG, Catherine N, Wicks A. Age-related incidence of publicly reported shaken baby syndrome cases: is crying a trigger for shaking?. J Dev Behav Pediatr 2007, 28:288-293. 10.1097/DBP.0b013e3180327b55, 17700080.
9. Savino F, Castagno E, Bretto R, Brondello C, Palumeri E, Oggero R. A prospective 10-year study on children who had severe infantile colic. Acta Paediatr Suppl 2005, 94:129-132. 10.1080/08035320510043691, 16214780.
10. Wolke D, Rizzo P, Woods S. Persistent infant crying and hyperactivity problems in middle childhood. Pediatrics 2002, 109:1054-1060. 10.1542/peds.109.6.1054, 12042542.
11. Brown M, Heine RG, Jordan B. Health and well-being in school-age children following persistent crying in infancy. J Paediatr Child Health 2009, 45:254-262. 10.1111/j.1440-1754.2009.01487.x, 19493116.
12. Rautava P, Lehtonen L, Helenius H. Infantile colic: child and family three years later. Pediatrics 1995, 96:43-47.
13. Hiscock H, Jordan B. Problem crying in infancy. Med J Aust 2004, 181:507-512.
14. Gupta SK. Is colic a gastrointestinal disorder?. Curr Opin Pediatr 2002, 14:588-592. 10.1097/00008480-200210000-00005, 12352253.
15. Geertsma MA, Hyams JS. Colic-a pain syndrome of infancy?. Pediatr Clin North Am 1989, 36:905-919.
16. Jordan B, Heine RG, Meehan M, Catto-Smith AG, Lubitz L. Effect of antireflux medication, placebo and infant mental health intervention on persistent crying: a randomized clinical trial. J Paediatr Child Health 2006, 42:49-58. 10.1111/j.1440-1754.2006.00786.x, 16487390.
17. Moore DJ, Tao BS, Lines DR, Hirte C, Heddle ML, Davidson GP. Double-blind placebo-controlled trial of omeprazole in irritable infants with gastroesophageal reflux. J Pediatr 2003, 143:219-223. 10.1067/S0022-3476(03)00207-5, 12970637.
18. Hill DJ, Roy N, Heine RG, Hosking CS, Francis DE, Brown J, Speirs B, Sadowsky J, Carlin JB. Effect of a low-allergen maternal diet on colic among breastfed infants: a randomized, controlled trial. Pediatrics 2005, 116:e709-e715. 10.1542/peds.2005-0147, 16263986.
19. Lucassen PL, Assendelft WJ, Gubbels JW, van Eijk JT, Douwes AC. Infantile colic: crying time reduction with a whey hydrolysate: A double-blind, randomized, placebo-controlled trial. Pediatrics 2000, 106:1349-1354. 10.1542/peds.106.6.1349, 11099588.
20. Jakobsson I, Lothe L, Ley D, Borschel MW. Effectiveness of casein hydrolysate feedings in infants with colic. Acta Paediatr 2000, 89:18-21. 10.1111/j.1651-2227.2000.tb01180.x, 10677051.
21. Jakobsson I, Lindberg T. Cow's milk proteins cause infantile colic in breast-fed infants: a double-blind crossover study. Pediatrics 1983, 71:268-271.
22. Hill DJ, Hudson IL, Sheffield LJ, Shelton MJ, Menahem S, Hosking CS. A low allergen diet is a significant intervention in infantile colic: results of a community-based study. J Allergy Clin Immunol 1995, 96:886-892. 10.1016/S0091-6749(95)70224-5, 8543745.
23. Rhoads JM, Fatheree NY, Norori J, Liu Y, Lucke JF, Tyson JE, Ferris MJ. Altered fecal microflora and increased fecal calprotectin in infants with colic. J Pediatr 2009, 155:823-828. e821, 10.1016/j.jpeds.2009.05.012, 19628216.
24. Olafsdottir E, Aksnes L, Fluge G, Berstad A. Faecal calprotectin levels in infants with infantile colic, healthy infants, children with inflammatory bowel disease, children with recurrent abdominal pain and healthy children. Acta Paediatr 2002, 91:45-50. 10.1111/j.1651-2227.2002.tb01638.x, 11883817.
25. Thompson-Chagoyan OC, Vieites JM, Maldonado J, Edwards C, Gil A. Changes in faecal microbiota of infants with cow's milk protein allergy - A Spanish prospective case-control 6-month follow-up study. Pediatr Allergy Immunol 2010, 21:e394-e400. 10.1111/j.1399-3038.2009.00961.x, 19889194.
26. Thompson-Chagoyan OC, Fallani M, Maldonado J, Vieites JM, Khanna S, Edwards C, Dore J, Gil A. Faecal microbiota and short-chain fatty acid levels in faeces from infants with cow's milk protein allergy. Int Arch Allergy Immunol 2011, 156:325-332. 10.1159/000323893, 21720179.
27. Lehtonen L, Korvenranta H, Eerola E. Intestinal microflora in colicky and noncolicky infants: bacterial cultures and gas-liquid chromatography. J Pediatr Gastroenterol Nutr 1994, 19:310-314. 10.1097/00005176-199410000-00009, 7815263.
28. Savino F, Cordisco L, Tarasco V, Calabrese R, Palumeri E. Matteuzz iD: Molecular identification of coliform bacteria from colicky breastfed infants. Acta Paediatrica, International Journal of Paediatrics 2009, 98:1582-1588.
29. Savino F, Cresi F, Pautasso S, Palumeri E, Tullio V, Roana J, Silvestro L, Oggero R. Intestinal microflora in breastfed colicky and non-colicky infants. Acta Paediatr 2004, 93:825-829. 10.1111/j.1651-2227.2004.tb03025.x, 15244234.
30. Savino F, Bailo E, Oggero R, Tullio V, Roana J, Carlone N, Cuffini AM, Silvestro L. Bacterial counts of intestinal Lactobacillus species in infants with colic. Pediatr Allergy Immunol 2005, 16:72-75. 10.1111/j.1399-3038.2005.00207.x, 15693915.
31. Partty AKM, Endo A, Salminen S, Isolauri E. Compositional development of Bifidobacterium and Lactobacillus microbiota is linked with crying and fussing in early infancy. PLoS One 2012, 7:e32495. 1-5, 10.1371/journal.pone.0032495, 3293811, 22403665.
32. Savino F, Cordisco L, Tarasco V, Locatelli E, Di Gioia D, Oggero R, Matteuzzi D. Antagonistic effect of Lactobacillus strains against gas-producing coliforms isolated from colicky infants. BMC Microbiol 2011, 11:157. 10.1186/1471-2180-11-157, 3224137, 21718486.
33. Indrio F, Riezzo G, Raimondi F, Bisceglia M, Cavallo L, Francavilla R. Effects of probiotic and prebiotic on gastrointestinal motility in newborns. J Physiol Pharmacol 2009, 60(Suppl 6):27-31.
34. Cohen-Silver J, Ratnapalan S. Management of infantile colic: a review. Clin Pediatr 2009, 48:14-17.
35. Garrison MM, Christakis DA. A systematic review of treatments for infant colic.[see comment]. Pediatrics 2000, 106:184-190.
36. Lucassen PL, Assendelft WJ. Systematic review of treatments for infant colic. Pediatrics 2001, 108:1047-1048. 10.1542/peds.108.4.1047, 11589211.
37. Wade S, Kilgour T. Extracts from "clinical evidence": Infantile colic. BMJ 2001, 323:437-440. 10.1136/bmj.323.7310.437, 1121035, 11520846.
38. Metcalf TJ, Irons TG, Sher LD, Young PC. Simethicone in the treatment of infant colic: A randomized, placebo- controlled, multicenter trial. Pediatrics 1994, 94:29-34.
39. Danielsson B, Hwang CP. Treatment of infantile colic with surface active substance (simethicone). Acta Paediatr Scand 1985, 74:446-450. 10.1111/j.1651-2227.1985.tb11001.x, 3890465.
40. Wallace B. Clinical use of probiotics in the pediatric population. Nutr Clin Pract 2009, 24:50-59. 10.1177/0884533608329298, 19244149.
41. Cabana MD, Shane AL, Chao C, Oliva-Hemker M. Probiotics in primary care pediatrics. Clin Pediatr 2006, 45:405-410.
42. Thomas DW, Greer FR. Probiotics and prebiotics in pediatrics. Pediatrics 2010, 126:1217-1231. 10.1542/peds.2010-2548, 21115585.
43. Penna FJ, Peret LA, Vieira LQ, Nicoli JR. Probiotics and mucosal barrier in children. Curr Opin Clin Nutr Metab Care 2008, 11:640-644. 10.1097/MCO.0b013e32830a70ab, 18685462.
44. Abrahamsson TR, Sinkiewicz G, Jakobsson T, Fredrikson M, Bjorksten B. Probiotic lactobacilli in breast milk and infant stool in relation to oral intake during the first year of life. J Pediatr Gastroenterol Nutr 2009, 49:349-354. 10.1097/MPG.0b013e31818f091b, 19525871.
45. Lahtinen SJ, Boyle RJ, Kivivuori S, Oppedisano F, Smith KR, Robins-Browne R, Salminen SJ, Tang MLK. Prenatal probiotic administration can influence Bifidobacterium microbiota development in infants at high risk of allergy. J Allergy Clin Immunol 2009, 123:499-501. 10.1016/j.jaci.2008.11.034, 19135234.
46. Spinelli M, Bastelli A, Capretti MG, Mariani E, Corvaglia L, Tripapalli E, Faldella G. Efficacy of oral supplementation with Lactobacillus reuteri in infants weighing less than 1500g in modifying the intestinal colonisation by Gram-negative bacteria. 28th National congress of antibiotic therapy in paediatrics. 2009, Milan, Italy.
47. Ren YF, Wang LL. Effects of probiotics on intestinal bacterial colonization in premature infants. Chinese Journal of Contemporary Pediatrics 2010, 12:192-194.
48. Mah KW, Chin VI, Wong WS, Lay C, Tannock GW, Shek LP, Aw MM, Chua KY, Wong HB, Panchalingham A, Lee BW. Effect of a milk formula containing probiotics on the fecal microbiota of asian infants at risk of atopic diseases. Pediatr Res 2007, 62:674-679. 10.1203/PDR.0b013e31815991d5, 17957155.
49. Lee SJ, Cho SJ, Park EA. Effects of probiotics on enteric flora and feeding tolerance in preterm infants. Neonatology 2007, 91:174-179. 10.1159/000097449, 17377402.
50. Mohan R, Koebnick C, Schildt J, Schmidt S, Mueller M, Possner M, Radke M, Blaut M. Effects of Bifidobacterium lactis Bb12 supplementation on intestinal microbiota of preterm infants: A double-blind, placebo-controlled, randomized study. J Clin Microbiol 2006, 44:4025-4031. 10.1128/JCM.00767-06, 1698302, 16971641.
51. Akiyama K, Hosono S, Takahashi E, Ishizeki S, Takigawa I, Imura S, Yamauchi K, Yaeshima T, Hayasawa H, Shimamura S. Effects of oral administration of Bifidobacterium breve on development of intestinal microflora in extremely premature infants. Acta Neonatologica Japonica 1994, 30:130-137.
52. Mentula S, Tuure T, Koskenala R, Korpela R, Kononen E. Microbial composition and fecal fermentation end products from colicky infants - a probiotic supplementation pilot. Microbial Ecology in Health and Disease 2008, 20:37-47.
53. Kamiya T, Wang L, Forsythe P, Goettsche G, Mao Y, Wang Y, Tougas G, Bienenstock J. Inhibitory effects of Lactobacillus reuteri on visceral pain induced by colorectal distension in Sprague-Dawley rats. Gut 2006, 55:191-196. 10.1136/gut.2005.070987, 1856513, 16361309.
54. Lutgendorff F, Akkermans LM, Soderholm JD. The role of microbiota and probiotics in stress-induced gastro-intestinal damage. Curr Mol Med 2008, 8:282-298. 10.2174/156652408784533779, 18537636.
55. Ma X, Mao Y-K, Wang B, Huizinga JD, Bienenstock J, Kunze W. Lactobacillus reuteri ingestion prevents hyperexcitability of colonic DRG neurons induced by noxious stimuli. Am J Physiol Gastrointest Liver Physiol 2009, 296:G868-G875. 10.1152/ajpgi.90511.2008, 19179624.
56. Rousseaux C, Thuru X, Gelot A, Barnich N, Neut C, Dubuquoy L, Dubuquoy C, Merour E, Geboes K, Chamaillard M, et al. Lactobacillus acidophilus modulates intestinal pain and induces opioid and cannabinoid receptors. Nat Med 2007, 13:35-37. 10.1038/nm1521, 17159985.
57. Wang B, Mao YK, Diorio C, Wang L, Huizinga JD, Bienenstock J, Kunze W. Lactobacillus reuteri ingestion and IK(Ca) channel blockade have similar effects on rat colon motility and myenteric neurones. Neurogastroenterol Motil 2010, 22:98-107.
58. Wang L, Ham H, Bienenstock J. Differential effects of two probiotic strains on pain perception of gastric and colonic distension in sprague dawley rats. Gastroenterology 2009, 136:A771. Conference:Digestive Disease Week.
59. Kunze WA, Mao YK, Wang B, Huizinga JD, Ma X, Forsythe P, Bienenstock J, Kunze WA, Mao Y-K, Wang B, et al. Lactobacillus reuteri enhances excitability of colonic AH neurons by inhibiting calcium-dependent potassium channel opening. J Cell Mol Med 2009, 13:2261-2270. 10.1111/j.1582-4934.2009.00686.x, 19210574.
60. Savino F, Pelle E, Palumeri E, Oggero R, Miniero R. Lactobacillus reuteri (American Type Culture Collection Strain 55730) versus simethicone in the treatment of infantile colic: a prospective randomized study. Pediatrics 2007, 119:e124-e130. 10.1542/peds.2006-1222, 17200238.
61. Savino F, Cordisco L, Tarasco V, Palumeri E, Calabrese R, Oggero R, Roos S, Matteuzzi D. Lactobacillus reuteri DSM 17 938 in Infantile Colic: A Randomized, Double-Blind, Placebo-Controlled Trial. Pediatrics 2010, 126:e526-e533. 10.1542/peds.2010-0433, 20713478.
62. Dupont C, Rivero M, Grillon C, Belaroussi N, Kalindjian A. Marin V: alpha-Lactalbumin-enriched and probiotic supplemented infant formula in infants with colic: growth and gastrointestinal tolerance. Eur J Clin Nutr 2010, 64:767.
63. GraphPad Statistics Guide Sample size for nonparametric tests http://www.graphpad.com/guides/prism/6/statistics/index.htm?stat_sample_size_for_nonparametric_.htmAccessed 13th August 2012, GraphPad Statistics Guide.
64. Lehmann E. Nonparametrics: Statistical Methods Based on Ranks, Revised 1998,
65. Barr RG, Kramer MS, Leduc DG, Boisjoly C, McVey-White L, Pless IB. Parental diary of infant cry and fuss behavior. Arch Dis Child 1988, 63:380-387. 10.1136/adc.63.4.380, 1778809, 3365007.
66. Barr RG, Kramer MS, Pless IB, Boisjoly C, Leduc D. Feeding and temperament as determinants of early infant crying/fussing behavior. Pediatrics 1989, 84:514-521.
67. Hunziker UA, Barr RG. Increased carrying reduces infant crying: a randomized controlled trial. Pediatrics 1986, 77:641-648.
68. Cox JL, Holden JM, Sagovski R. Detection of postnatal depression: development of a 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry 1987, 150:1172-1175.
69. Varni JW, Sherman SA, Burwinkle TM, Dickinson PE, Dixon P. The PedsQLTM Family Impact Module: Preliminary reliability and validity. Health Qual Life Outcomes 2004, 2:1-6. 10.1186/1477-7525-2-1, 333432, 14713317.
70. Varni JW, Burwinkle TM, Seid M, Skarr D. The PedsQL 4.0 as a pediatric population health measure: feasibility, reliability, and validity. Ambul Pediatr 2003, 3:329-341. 10.1367/1539-4409(2003)003<0329:TPAAPP>2.0.CO;2, 14616041.
71. Hawthorne G, Richardson J. Atherton Day M: A comparison of the Assessment of Quality of LIfe (AQoL) with four other generic utility instruments. Ann Med 2001, 33:358-370. 10.3109/07853890109002090, 11491195.
72. Osborne CA, Rees GN, Bernstein Y, Janssen PH. New threshold and confidence estimates for terminal restriction fragment length polymorphism analysis of complex bacterial communities. Appl Environ Microbiol 2006, 72:1270-1278. 10.1128/AEM.72.2.1270-1278.2006, 1392978, 16461676.
73. CALPRO CalproLab ELISA kit http://www.calpro.no/uploads/pdf/110831_CalproLab%20ALP%20ELISA.pdf Accessed 14th August 2012. 2012, CALPRO.
74. Chern EC, Siefring S, Paar J, Doolittle M, Haugland RA. Comparison of quantitative PCR assays for Escherichia coli targeting ribosomal RNA and single copy genes. Lett Appl Microbiol 2011, 52:298-306. 10.1111/j.1472-765X.2010.03001.x, 21204885.
75. Orenstein SR, Cohn JF, Shalaby TM, Kartan R. Reliability and validity of an infant gastroesophageal reflux questionnaire. Clin Pediatr 1993, 32:472-484.
76. Kleinman L, Rothman M, Strauss R, Orenstein SR, Nelson S, Vandenplas Y, Cucchiara S, Revicki DA. The Infant Gastroesophageal Reflux Questionnaire Revised: development and validation as an evaluative instrument. Clin Gastroenterol Hepatol 2006, 4:588-596. 10.1016/j.cgh.2006.02.016, 16678075.
77. Million MMM, Henry M, Armougom F, Richet H, Carrieri P, Valero R, Raccah D. Vialettes B, Raoult D: Obesity-associated gut microbiota is enriched in Lactobacillus reuteri and depleted in Bifidobacterium animalis and Methanobrevibacter smithii. Int J Obes (Lond) 2012, 36:817-825.