Gastroesophageal Reflux Disease in Children with Interstitial Lung Disease.

Gastroesophageal reflux disease is common in adult patients with interstitial lung disease. However, no data currently exist regarding the prevalence and characteristics of the disease in pediatric patients with interstitial lung disease. The aim of the present study was to prospectively assess the incidence of gastroesophageal reflux disease and characterize its features in children with interstitial lung disease. Gastroesophageal reflux disease was established based on 24 h pH-impedance monitoring (MII-pH). Gastroesophageal reflux episodes (GERs) were classified according to widely recognized criteria as acid, weakly acid, weakly alkaline, or proximal. Eighteen consecutive patients (15 boys, aged 0.2-11.6 years) were enrolled in the study. Gastroesophageal reflux disease was diagnosed in a half (9/18) of children. A thousand GERs were detected by MII-pH (median 53.5; IQR 39.0-75.5). Of these, 585 (58.5 %) episodes were acidic, 407 (40.7 %) were weakly acidic, and eight (0.8 %) were weakly alkaline. There were 637 (63.7 %) proximal GERs. The patients in whom gastroesophageal reflux disease was diagnosed had a significantly higher number of proximal and total GERs. We conclude that the prevalence of gastroesophageal reflux disease in children with interstitial lung disease is high; thus, the disease should be considered regardless of presenting clinical symptoms. A high frequency of non-acid and proximal GERs makes the MII-pH method a preferable choice for the detection of reflux episodes in this patient population.

Switching Between Infliximab Originator and Biosimilar in Paediatric Patients with Inflammatory Bowel Disease. Preliminary Observations.

BACKGROUND AND AIMS: The growing incidence of inflammatory bowel disease (IBD) in children necessitates the use of biological treatments. Recently, an infliximab biosimilar was authorized in the European Union, which may result in switching patients. We present our preliminary experiences with such switches. METHODS: The prospective study included 32 paediatric patients diagnosed with Crohn's disease (CD) and 7 children with ulcerative colitis (UC) at 3 academic hospitals, who were switched from infliximab originator to its biosimilar (Remsima). Patient characteristics, disease severity, laboratory parameters and adverse events were recorded. Means, medians and ranges were calculated. RESULTS: Mean age at diagnosis of CD and UC was 11.1 (2.7-15.3) and 12.3 years (8.5-14.8), respectively. Mean number of infliximab originator infusions before switching to the biosimilar was 9.9 (median 8, range 4-29) and 5.1 (5, 1-12) for the CD and UC group, respectively. Evaluation efficacy of last biosimilar doses of all patients revealed rates of clinical remission of 88 and 57% for CD and UC patients, respectively. Last follow-up assessment of patients who continued with biosimilar therapy showed that 16/20 (80%) CD patients and all 4 UC individuals were in remission. One infusion reaction to infliximab biosimilar was observed in a CD patient, which led to treatment discontinuation. The incidence of sporadic mild adverse events prior to and after switching did not differ significantly and was consistent with the safety profile of the infliximab molecule. CONCLUSION: Switching from infliximab originator to its biosimilar seems to be a safe option in children with CD. After the switch the biosimilar was just as effective as the originator.

Lack of effect of Lactobacillus GG in breast-fed infants with rectal bleeding: a pilot double-blind randomized controlled trial.

OBJECTIVES: For breast-fed infants with rectal bleeding, maternal restriction of dietary protein such as cow's milk proteins is often recommended; however, poor response to dietary protein restriction is of concern. This pilot study was designed to assess the effectiveness of Lactobacillus GG (LGG) in breast-fed infants with rectal bleeding. PATIENTS AND METHODS: Breast-fed infants <6 months of age with rectal bleeding (defined as the presence of visible specks or streaks of blood mixed with mucus in the stool in otherwise healthy infants) were enrolled in a double-blind randomized controlled trial in which they received LGG 3 x 10 colony-forming units (n = 14) or placebo (n = 15) twice daily for 4 weeks as an adjunct to cow's milk restriction in the mother's diet. Analyses were based on allocated treatment and included data from 26 infants. RESULTS: Mean duration of rectal bleeding was similar in the LGG and control groups (17.3 +/- 10.6 vs 15.4 +/- 11 days; mean difference -1.9 (95% confidence interval [CI] -4 to 7). No difference was found in the number of infants with clinical resolution of rectal bleeding within 72 hours and no relapse afterward (2/11 vs 3/15, relative risk [RR] 0.9, 95% CI 0.2-3.9) and the number of infants with clinical resolution of rectal bleeding within 72 hours followed by relapse of symptoms (5/11 vs 5/15, RR 1.4, 95% CI 0.5-3.5). Breast-feeding cessation was not needed in any infant. CONCLUSIONS: These results do not support the use of LGG as an adjunct to maternal cow's milk restriction in breast-fed infants with rectal bleeding.

A randomized double-blind placebo-controlled trial of Lactobacillus GG for abdominal pain disorders in children.

BACKGROUND: Functional abdominal pain disorders (FAPD) are common in school-aged children; however, there is no reliable treatment. AIM: To determine the efficacy of Lactobacillus rhamnosus GG (LGG) for treating FAPD in children. METHODS: A total of 104 children who fulfilled the Rome II criteria for functional dyspepsia (FD), or irritable bowel syndrome (IBS), or functional abdominal pain (FAP) were enrolled in a double-blind, randomized controlled trial in which they received LGG (n = 52), or placebo (n = 52) for 4 weeks. RESULTS: For the overall study population, those in the LGG group were more likely to have treatment success (no pain) than those in the placebo group (25% vs. 9.6%, relative benefit (RB) 2.6, 95% confidence interval (CI): 1.05-6.6, number needed to treat (NNT) 7, 95% CI: 4-123). For children with IBS (n = 37), those in the LGG group were more likely to have treatment success than those in the placebo group (33% vs. 5%, RB 6.3, 95% CI: 1.2-38, NNT 4, 95% CI: 2-36) and reduced frequency of pain (P = 0.02), but not pain severity (P = 0.10). For the FD group (n = 20) and FAP group (n = 47), no differences were found. CONCLUSION: The LGG appears to moderately increase treatment success, particularly among children with IBS.