{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,13]],"date-time":"2026-02-13T07:35:47Z","timestamp":1770968147454,"version":"3.50.1"},"reference-count":33,"publisher":"Becaris Publishing Limited","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. Comp. Eff. Res."],"published-print":{"date-parts":[[2017,3]]},"abstract":"<jats:p>\n            <jats:bold>Aim:<\/jats:bold>\n            Comparing efficacy and safety of APT198K (xyloglucan plus heat-killed\n            <jats:italic>Lactobacillus reuteri<\/jats:italic>\n            SGL01 and\n            <jats:italic>Bifidobacterium brevis<\/jats:italic>\n            SGB01) versus a lactase dietary supplement as first-line treatment of infantile colic.\n            <jats:bold>Methods:<\/jats:bold>\n            Randomized, multicenter, open-label, parallel group, active-controlled study, in 46 infants aged 3\u201316 weeks with infantile colic, receiving APT198K or a lactase dietary supplement for 10 days.\n            <jats:bold>Results:<\/jats:bold>\n            Number and duration of crying episodes decreased significantly versus baseline in both groups. On day 8, the mean duration of crying per episode was significantly shorter in the APT198K group compared with the lactase group (9.14 \u00b1 5.34 vs 13.22 \u00b1 5.29 min; p = 0.014) and remained so up to day 11.\n            <jats:bold>Conclusion:<\/jats:bold>\n            APT198K decreased the mean duration per crying episode significantly more than a lactase dietary supplement in infants with colic. Further evaluation in larger studies is warranted.\n            <jats:bold>Clinical trial registry:<\/jats:bold>\n            EudraCT number 2014-002860-334;\n            <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/eudract.ema.europa.eu\" xlink:type=\"simple\">https:\/\/eudract.ema.europa.eu<\/jats:ext-link>\n            .\n          <\/jats:p>","DOI":"10.2217\/cer-2016-0059","type":"journal-article","created":{"date-parts":[[2017,1,24]],"date-time":"2017-01-24T09:04:52Z","timestamp":1485248692000},"page":"137-144","source":"Crossref","is-referenced-by-count":26,"title":["Efficacy and safety of APT198K for the treatment of infantile colic: a pilot study"],"prefix":"10.57264","volume":"6","author":[{"given":"Yvan","family":"Vandenplas","sequence":"first","affiliation":[{"name":"Department of Pediatrics, UZ Brussel, Vrije Universiteit Brussel, Brussels, Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anca","family":"Bacarea","sequence":"additional","affiliation":[{"name":"University of Medicine &amp; Pharmacy T\u00e2rgu Mure\u015f City, Romania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marius","family":"Marusteri","sequence":"additional","affiliation":[{"name":"University of Medicine &amp; Pharmacy T\u00e2rgu Mure\u015f City, Romania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vlad","family":"Bacarea","sequence":"additional","affiliation":[{"name":"University of Medicine &amp; Pharmacy T\u00e2rgu Mure\u015f City, Romania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mariana","family":"Constantin","sequence":"additional","affiliation":[{"name":"Private Practice of Family Medicine, Pitesti City, Romania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mihai","family":"Manolache","sequence":"additional","affiliation":[{"name":"CEBIS International Ltd, Bucharest, Romania"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"36897","reference":[{"issue":"5","key":"e_1_3_3_3_2","doi-asserted-by":"crossref","first-page":"531","DOI":"10.1097\/MPG.0000000000000949","article-title":"Prevalence and health outcomes of functional gastrointestinal symptoms in infants from birth to 12 months of age","volume":"61","author":"Vandenplas Y","year":"2015","unstructured":"Vandenplas Y , Abkari A , Bellaiche M Prevalence and health outcomes of functional gastrointestinal symptoms in infants from birth to 12 months of age . J. Pediatr. Gastroenterol. Nutr. 61 ( 5 ), 531 \u2013 537 ( 2015 ).","journal-title":"J. Pediatr. Gastroenterol. Nutr."},{"issue":"1","key":"e_1_3_3_4_2","doi-asserted-by":"crossref","first-page":"S27","DOI":"10.1097\/01.mpg.0000441931.07469.c0","article-title":"Treatments for infant colic","volume":"57","author":"Bellaiche M","year":"2013","unstructured":"Bellaiche M , Levy M , Jung C . Treatments for infant colic . J. Pediatr. Gastroenterol. Nutr. 57 ( Suppl. 1 ), S27 \u2013 S30 ( 2013 ).","journal-title":"J. Pediatr. Gastroenterol. Nutr."},{"key":"e_1_3_3_5_2","doi-asserted-by":"crossref","first-page":"1443","DOI":"10.1053\/j.gastro.2016.02.016","article-title":"Childhood functional gastrointestinal disorders: neonate\/toddler","volume":"150","author":"Benninga MA","year":"2016","unstructured":"Benninga MA , Nurko S , Faure C Childhood functional gastrointestinal disorders: neonate\/toddler . Gastroenterology 150 , 1443 \u2013 1455 ( 2016 ).","journal-title":"Gastroenterology"},{"issue":"4","key":"e_1_3_3_6_2","first-page":"735","article-title":"Infantile colic","volume":"70","author":"Roberts DM","year":"2004","unstructured":"Roberts DM , Ostapchuk M , O'Brien JG . Infantile colic . Am. Fam. Physician 70 ( 4 ), 735 \u2013 740 ( 2004 ).","journal-title":"Am. Fam. Physician"},{"key":"e_1_3_3_7_2","doi-asserted-by":"crossref","first-page":"53","DOI":"10.1186\/1824-7288-40-53","article-title":"Looking for new treatments of infantile colic","volume":"40","author":"Savino F","year":"2014","unstructured":"Savino F , Ceratto S , De Marco A , di Montezemolo LC . Looking for new treatments of infantile colic . Ital. J. Pediatr. 40 , 53 ( 2014 ).","journal-title":"Ital. J. Pediatr."},{"issue":"5","key":"e_1_3_3_8_2","doi-asserted-by":"crossref","first-page":"668","DOI":"10.1097\/MPG.0000000000001075","article-title":"Infant colic \u2013 what works: a systematic review of interventions for breastfed infants","volume":"62","author":"Harb T","year":"2016","unstructured":"Harb T , Matsuyama M , David M , Hill R . Infant colic \u2013 what works: a systematic review of interventions for breastfed infants . J. Pediatr. Gastroenterol. Nutr. 62 ( 5 ), 668 \u2013 686 ( 2016 ).","journal-title":"J. Pediatr. Gastroenterol. Nutr."},{"key":"e_1_3_3_9_2","doi-asserted-by":"crossref","first-page":"84","DOI":"10.1186\/s13052-015-0193-8","article-title":"Advances in pediatrics in 2014: current practices and challenges in allergy, gastroenterology, infectious diseases, neonatology, nutrition, oncology and respiratory tract illnesses","volume":"41","author":"Caffarelli C","year":"2015","unstructured":"Caffarelli C , Santamaria F , Cesari S Advances in pediatrics in 2014: current practices and challenges in allergy, gastroenterology, infectious diseases, neonatology, nutrition, oncology and respiratory tract illnesses . Ital. J. Pediatr. 41 , 84 ( 2015 ).","journal-title":"Ital. J. Pediatr."},{"issue":"3","key":"e_1_3_3_10_2","doi-asserted-by":"crossref","first-page":"e32495","DOI":"10.1371\/journal.pone.0032495","article-title":"Compositional development of Bifidobacterium and Lactobacillus microbiota is linked with crying and fussing in early infancy","volume":"7","author":"P\u00e4rtty A","year":"2012","unstructured":"P\u00e4rtty A , Kalliom\u00e4ki M , Endo A , Salminen S , Isolauri E . Compositional development of Bifidobacterium and Lactobacillus microbiota is linked with crying and fussing in early infancy . PLoS ONE 7 ( 3 ), e32495 ( 2012 ).","journal-title":"PLoS ONE"},{"issue":"10","key":"e_1_3_3_11_2","doi-asserted-by":"crossref","first-page":"1582","DOI":"10.1111\/j.1651-2227.2009.01419.x","article-title":"Molecular identification of coliform bacteria from colicky breastfed infants","volume":"98","author":"Savino F","year":"2009","unstructured":"Savino F , Cordisco L , Tarasco V , Calabrese R , Palumeri E , Matteuzzi D . Molecular identification of coliform bacteria from colicky breastfed infants . Acta Paediatr. 98 ( 10 ), 1582 \u2013 1588 ( 2009 ).","journal-title":"Acta Paediatr."},{"issue":"10","key":"e_1_3_3_12_2","doi-asserted-by":"crossref","first-page":"e0141445","DOI":"10.1371\/journal.pone.0141445","article-title":"The efficacy and safety of the probiotic bacterium Lactobacillus reuteri DSM 17938 for infantile colic: a meta-analysis of randomized controlled trials","volume":"10","author":"Xu M","year":"2015","unstructured":"Xu M , Wang J , Wang N , Sun F , Wang L , Liu XH . The efficacy and safety of the probiotic bacterium Lactobacillus reuteri DSM 17938 for infantile colic: a meta-analysis of randomized controlled trials . PLoS ONE 10 ( 10 ), e0141445 ( 2015 ).","journal-title":"PLoS ONE"},{"issue":"9","key":"e_1_3_3_13_2","doi-asserted-by":"crossref","first-page":"546","DOI":"10.1111\/j.1753-4887.2009.00226.x","article-title":"Probiotic microbes: do they need to be alive to be beneficial?","volume":"67","author":"Kataria J","year":"2009","unstructured":"Kataria J , Li N , Wynn JL , Neu J . Probiotic microbes: do they need to be alive to be beneficial? Nutr. Rev. 67 ( 9 ), 546 \u2013 550 ( 2009 ).","journal-title":"Nutr. Rev."},{"issue":"1","key":"e_1_3_3_14_2","doi-asserted-by":"crossref","first-page":"37","DOI":"10.1017\/S0954422410000090","article-title":"The probiotic paradox: live and dead cells are biological response modifiers","volume":"23","author":"Adams CA","year":"2010","unstructured":"Adams CA . The probiotic paradox: live and dead cells are biological response modifiers . Nutr. Res. Rev. 23 ( 1 ), 37 \u2013 46 ( 2010 ).","journal-title":"Nutr. Res. Rev."},{"issue":"5","key":"e_1_3_3_15_2","doi-asserted-by":"crossref","first-page":"359","DOI":"10.1046\/j.1365-277X.2001.00304.x","article-title":"Improvement of symptoms in infant colic following reduction of lactose load with lactase","volume":"14","author":"Kanabar D","year":"2001","unstructured":"Kanabar D , Randhawa M , Clayton P . Improvement of symptoms in infant colic following reduction of lactose load with lactase . J. Hum. Nutr. Diet 14 ( 5 ), 359 \u2013 363 ( 2001 ).","journal-title":"J. Hum. Nutr. Diet"},{"issue":"5","key":"e_1_3_3_16_2","doi-asserted-by":"crossref","first-page":"725","DOI":"10.1136\/adc.64.5.725","article-title":"Breath hydrogen excretion in infants with colic","volume":"64","author":"Miller JJ","year":"1989","unstructured":"Miller JJ , McVeagh P , Fleet GH , Petocz P , Brand JC . Breath hydrogen excretion in infants with colic . Arch. Dis. Child. 64 ( 5 ), 725 \u2013 729 ( 1989 ).","journal-title":"Arch. Dis. Child."},{"issue":"5","key":"e_1_3_3_17_2","doi-asserted-by":"crossref","first-page":"421","DOI":"10.1542\/peds.14.5.421","article-title":"Paroxysmal fussing in infancy, sometimes called colic","volume":"14","author":"Wessel MA","year":"1954","unstructured":"Wessel MA , Cobb JC , Jackson EB , Harris GS , Detwiler AC . Paroxysmal fussing in infancy, sometimes called colic . Pediatrics 14 ( 5 ), 421 \u2013 435 ( 1954 ).","journal-title":"Pediatrics"},{"issue":"1","key":"e_1_3_3_18_2","doi-asserted-by":"crossref","first-page":"14","DOI":"10.1177\/0009922808323116","article-title":"Management of infantile colic: a review","volume":"48","author":"Cohen-Silver J","year":"2009","unstructured":"Cohen-Silver J , Ratnapalan S . Management of infantile colic: a review . Clin. Pediatr. (Phila.) 48 ( 1 ), 14 \u2013 17 ( 2009 ).","journal-title":"Clin. Pediatr. (Phila.)"},{"issue":"6","key":"e_1_3_3_19_2","doi-asserted-by":"crossref","first-page":"e1857","DOI":"10.1542\/peds.2012-3316","article-title":"Inconsolable infant crying and maternal postpartum depressive symptoms","volume":"131","author":"Radesky JS","year":"2013","unstructured":"Radesky JS , Zuckerman B , Silverstein M Inconsolable infant crying and maternal postpartum depressive symptoms . Pediatrics 131 ( 6 ), e1857 \u2013 e1864 ( 2013 ).","journal-title":"Pediatrics"},{"issue":"4","key":"e_1_3_3_20_2","first-page":"391","article-title":"Psychosocial status and quality of life in mothers of infants with colic","volume":"55","author":"Abac\u0131 FB","year":"2013","unstructured":"Abac\u0131 FB , G\u00f6k\u00e7e S , Tuygun N , Karacan CD , \u0150ner \u0150 . Psychosocial status and quality of life in mothers of infants with colic . Turk. J. Pediatr. 55 ( 4 ), 391 \u2013 395 ( 2013 ).","journal-title":"Turk. J. Pediatr."},{"issue":"1","key":"e_1_3_3_21_2","doi-asserted-by":"crossref","first-page":"47","DOI":"10.1093\/pch\/16.1.47","article-title":"Infantile colic: is there a role for dietary interventions?","volume":"16","author":"Critch J","year":"2011","unstructured":"Critch J . Infantile colic: is there a role for dietary interventions? Paediatr. Child Health 16 ( 1 ), 47 \u2013 49 ( 2011 ).","journal-title":"Paediatr. Child Health"},{"issue":"2","key":"e_1_3_3_22_2","doi-asserted-by":"crossref","first-page":"e550","DOI":"10.1542\/peds.2012-1449","article-title":"Intestinal microbiota of infants with colic: development and specific signatures","volume":"131","author":"de Weerth C","year":"2013","unstructured":"de Weerth C , Fuentes S , Puylaert P , de Vos WM . Intestinal microbiota of infants with colic: development and specific signatures . Pediatrics 131 ( 2 ), e550 \u2013 e558 ( 2013 ).","journal-title":"Pediatrics"},{"issue":"1","key":"e_1_3_3_23_2","doi-asserted-by":"crossref","first-page":"72","DOI":"10.1111\/j.1399-3038.2005.00207.x","article-title":"Bacterial counts of intestinal Lactobacillus species in infants with colic","volume":"16","author":"Savino F","year":"2005","unstructured":"Savino F , Bailo E , Oggero R Bacterial counts of intestinal Lactobacillus species in infants with colic . Pediatr. Allergy Immunol. 16 ( 1 ), 72 \u2013 75 ( 2005 ).","journal-title":"Pediatr. Allergy Immunol."},{"issue":"6","key":"e_1_3_3_24_2","doi-asserted-by":"crossref","first-page":"823","DOI":"10.1016\/j.jpeds.2009.05.012","article-title":"Altered fecal microflora and increased fecal calprotectin in infants with colic","volume":"155","author":"Rhoads JM","year":"2009","unstructured":"Rhoads JM , Fatheree NY , Norori J Altered fecal microflora and increased fecal calprotectin in infants with colic . J. Pediatr. 155 ( 6 ), 823 \u2013 828.e1 ( 2009 ).","journal-title":"J. Pediatr."},{"issue":"3","key":"e_1_3_3_25_2","doi-asserted-by":"crossref","first-page":"310","DOI":"10.1097\/00005176-199410000-00009","article-title":"Intestinal microflora in colicky and noncolicky infants: bacterial cultures and gas-liquid chromatography","volume":"19","author":"Lehtonen L","year":"1994","unstructured":"Lehtonen L , Korvenranta H , Eerola E . Intestinal microflora in colicky and noncolicky infants: bacterial cultures and gas-liquid chromatography . J. Pediatr. Gastroenterol. Nutr. 19 ( 3 ), 310 \u2013 314 ( 1994 ).","journal-title":"J. Pediatr. Gastroenterol. Nutr."},{"key":"e_1_3_3_26_2","doi-asserted-by":"crossref","first-page":"301053","DOI":"10.1155\/2014\/301053","article-title":"The probiotic Bifidobacterium breve B632 inhibited the growth of Enterobacteriaceae within colicky infant microbiota cultures","volume":"2014","author":"Simone M","year":"2014","unstructured":"Simone M , Gozzoli C , Quartieri A The probiotic Bifidobacterium breve B632 inhibited the growth of Enterobacteriaceae within colicky infant microbiota cultures . Biomed. Res. Int. 2014 , 301053 ( 2014 ).","journal-title":"Biomed. Res. Int."},{"key":"e_1_3_3_27_2","doi-asserted-by":"crossref","first-page":"157","DOI":"10.1186\/1471-2180-11-157","article-title":"Antagonistic effect of Lactobacillus strains against gas-producing coliforms isolated from colicky infants","volume":"11","author":"Savino F","year":"2011","unstructured":"Savino F , Cordisco L , Tarasco V Antagonistic effect of Lactobacillus strains against gas-producing coliforms isolated from colicky infants . BMC Microbiol. 11 , 157 ( 2011 ).","journal-title":"BMC Microbiol."},{"issue":"1","key":"e_1_3_3_28_2","doi-asserted-by":"crossref","first-page":"74","DOI":"10.1016\/j.jpeds.2014.09.020","article-title":"Probiotics for infantile colic: a randomized, double-blind, placebo-controlled trial investigating Lactobacillus reuteri DSM 17938","volume":"166","author":"Chau K","year":"2015","unstructured":"Chau K , Lau E , Greenberg S Probiotics for infantile colic: a randomized, double-blind, placebo-controlled trial investigating Lactobacillus reuteri DSM 17938 . J. Pediatr. 166 ( 1 ), 74 \u2013 78 ( 2015 ).","journal-title":"J. Pediatr."},{"key":"e_1_3_3_29_2","doi-asserted-by":"crossref","first-page":"g2107","DOI":"10.1136\/bmj.g2107","article-title":"Treating infant colic with the probiotic Lactobacillus reuteri: double blind, placebo controlled randomised trial","volume":"348","author":"Sung V","year":"2014","unstructured":"Sung V , Hiscock H , Tang ML Treating infant colic with the probiotic Lactobacillus reuteri: double blind, placebo controlled randomised trial . BMJ 348 , g2107 ( 2014 ).","journal-title":"BMJ"},{"key":"e_1_3_3_30_2","volume-title":"United European Gastroenterology Week","author":"Bueno L","year":"2014","unstructured":"Bueno L , Theodorou V , Sekkal S . Xyloglucan: a new agent to protect the intestinal mucosa and to prevent bacterially-mediated alteration of tight junction permeability [Abstract P1675] . Presented at : United European Gastroenterology Week . Vienna, Austria , 18\u201322 October 2014 ."},{"issue":"1","key":"e_1_3_3_31_2","doi-asserted-by":"crossref","first-page":"153","DOI":"10.1186\/s12876-015-0386-z","article-title":"Xyloglucan for the treatment of acute diarrhea: results of a randomized, controlled, open-label, parallel group, multicentre, national clinical trial","volume":"15","author":"Gnessi L","year":"2015","unstructured":"Gnessi L , Bacarea V , Marusteri M , Picqu\u00e9 N . Xyloglucan for the treatment of acute diarrhea: results of a randomized, controlled, open-label, parallel group, multicentre, national clinical trial . BMC Gastroenterol. 15 ( 1 ), 153 ( 2015 ).","journal-title":"BMC Gastroenterol."},{"issue":"12","key":"e_1_3_3_32_2","doi-asserted-by":"crossref","first-page":"1232","DOI":"10.1136\/adc.61.12.1232","article-title":"Infantile colic and feeding","volume":"61","author":"St\u00e5hlberg MR","year":"1986","unstructured":"St\u00e5hlberg MR , Savilahti E . Infantile colic and feeding . Arch. Dis. Child. 61 ( 12 ), 1232 \u2013 1233 ( 1986 ).","journal-title":"Arch. Dis. Child."},{"issue":"2","key":"e_1_3_3_33_2","doi-asserted-by":"crossref","first-page":"261","DOI":"10.1016\/S0022-3476(05)80542-6","article-title":"Effect of yeast lactase enzyme on \u201ccolic\u201d in infants fed human milk","volume":"117","author":"Miller JJ","year":"1990","unstructured":"Miller JJ , McVeagh P , Fleet GH , Petocz P , Brand JC . Effect of yeast lactase enzyme on \u201ccolic\u201d in infants fed human milk . J. Pediatr. 117 ( 2 Pt 1 ), 261 \u2013 263 ( 1990 ).","journal-title":"J. Pediatr."},{"issue":"4","key":"e_1_3_3_34_2","doi-asserted-by":"crossref","first-page":"281","DOI":"10.1046\/j.1365-277X.1998.00108.x","article-title":"A trial of lactase in the management of infant colic","volume":"11","author":"Kearney PJ","year":"1998","unstructured":"Kearney PJ , Malone AJ , Hayes T , Cole M , Hyland M . A trial of lactase in the management of infant colic . J. Hum. Nutr. Dietet. 11 ( 4 ), 281 \u2013 285 ( 1998 ).","journal-title":"J. Hum. Nutr. Dietet."},{"key":"e_1_3_3_35_2","unstructured":"National Institute for Health and Care Excellence (NICE)\n                                            . \n                                            Clinical knowledge summaries: colic \u2013 infantile (November 2014)\n                                            . \n                                            http:\/\/cks.nice.org.uk\/colic-infantile\n                                            ."}],"container-title":["Journal of Comparative Effectiveness Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.futuremedicine.com\/doi\/pdf\/10.2217\/cer-2016-0059","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,2,17]],"date-time":"2023-02-17T14:59:16Z","timestamp":1676645956000},"score":1,"resource":{"primary":{"URL":"https:\/\/becarispublishing.com\/doi\/10.2217\/cer-2016-0059"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,3]]},"references-count":33,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2017,3]]}},"alternative-id":["10.2217\/cer-2016-0059"],"URL":"https:\/\/doi.org\/10.2217\/cer-2016-0059","relation":{},"ISSN":["2042-6305","2042-6313"],"issn-type":[{"value":"2042-6305","type":"print"},{"value":"2042-6313","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,3]]}}}