468R. Berni Canani et al. / Digestive and Liver Disease 36 (2004) 467–470Table 1Main demographic characteristics of the study subjectsNo.MaleMedian age,months (range)Controls763578.6 (13–216))Functional disorders441660.3 (13–151)Crohn’s disease6846150.0 (137–209)Ulcerative colitis4533159.0 (101–216)Allergic colitis371243.6 (24–96)Coeliac disease381737.4 (15–81)Polyposis52125.0 (81–168)Acute Gastroenteritis14524.8 (14–38)Gastroesophageal reflux disease17669.5 (13–123)Pouchitis54122.0 (105–210)Hirshsprung’s disease4321.0 (13–32)Congenital chloride diarrhoea2286.0 (70–103)Bile salt malabsorption2214 (13–15)was to assess FC values in common gastrointestinal diseasesin paediatric clinical practice comparing them with thoseobtained in healthy subjects. In addition, reference FC val-ues for healthy children were also presented for convenientuse in clinical practice.2. Patients and methodsChildren (age range 13–216 months) consecutively re-ferred to our department for gastrointestinal symptomswere invited to participate in the study. Two hundred andeighty-one children with gastrointestinal diseases were en-rolled. As controls, a faecal sample was obtained from 76healthy children. These subjects were recruited from chil-dren visiting our department for routine examination andalso from families of our staff. The exclusion criteria werethe following: any known underlying chronic disease ora history of abdominal pain, diarrhoea, acute respiratorytract infection, intake of non-steroidal anti-inflammatorydrugs, gastric acidity inhibitors, antibiotics, drugs influenc-ing gut motility, and menstrual or nasal bleeding in the last3 weeks. The main demographic characteristics of the en-rolled children are reported inTable 1. In children affectedby IBD, coeliac disease or allergic colitis, established clin-ical, laboratory, endoscopic and histological criteria wereused in the initial diagnosis and to assess disease activity[9–11]. In children affected by functional disorders thediagnosis was made using the Rome II criteria[12]. Onestool specimen was collected by each subject using a dis-posable plastic bucket-type device to avoid contact withtoilet water and simplify laboratory sampling. In childrenwith diapers, stools were collected directly from the bottominto a test tube to avoid water absorption by the diaperswhich may increase FC value[2]. Only pre-endoscopy fae-cal samples were analyzed. Samples were stored at−20◦Cand thawed at room temperature before testing. The FCvalues were analyzed by a commercially available ELISAassay (Calprest®, Eurospital Spa, Trieste, Italy), as previ-Table 2Faecal calprotectin values in paediatric gastrointestinal diseasesDiseaseNMedian faecal calprotectinvalues (range)Gastroesophageal reflux disease17138∗(49–300)Acute gastroenteritis14110∗(0.3–244)Polyposis5229∗(157–240)Hirschprung’s disease513.7 (8–36)Pouchites4256.7∗(125–318)Bile salt malabsorption214.5 (3–28)Congenital chloride diarrhoea220.4 (7–41)Controls7628 (1–113)∗P<0.001 vs. controls.ously reported[3,13]. Using this method a coefficient of19.1% of day-to-day variation in FC values was previouslyreported in a paediatric population[4]. Informed consentwas obtained from the parents of all subjects. The protocolwas approved by the Ethics Committee of our Institution.The statistical analysis was performed using the SPSSsoftware package for Windows (release 11.5.2.1, 4 Apr2003; SPSS Inc., Chicago, Ill., USA). Faecal calpro-tectin values in the different groups were compared byMann–WhitneyUtest and by the Kruskal–WallisHtestwith the Dunn test for the post hoc analysis. All tests ofsignificance were two-sided. APvalue of 0.05 or less wasconsidered significant. Simple regression analysis was usedto assess the correlation between FC concentration andage in healthy controls. The ROC curve was obtained withStatsDirect statistical software (release 2.3.3, 15 September2003).3. ResultsThe FC values in healthy children and in patients withvarious gastrointestinal disorders are reported inFig. 1andinTable 2. In healthy children the median FC value was28.0g/g (15–57 interquartile range). There were no dif-ferences in FC values attributable to age or sex. The 5th,50th and 95th percentile FC values in healthy controls were3.0, 28.0 and 95.3g/g, respectively. Children with activeIBD, defined by clinical, endoscopic and histological pa-rameters, showed significantly higher FC values comparedwith those obtained in healthy children(P<0.001)or inIBD subjects in remission(P<0.001). In addition, in fivechildren affected by active pouchitis we observed a sig-nificant increase of FC values, as reported inTable 2.Onthe contrary, IBD children in clinical remission showed FCvalues not statistically different from the controls (Fig. 1).Similarly, children with active allergic colitis or coeliac dis-ease showed significantly higher FC values compared withcontrols(P<0.001)and a reducing pattern toward normalvalues after at least 4 weeks of exclusion diet (P<0.001active versus remission), as shown inFig. 1. Patients withacute gastroenteritis (10Rotavirus,2Salmonella enteritidis,