Phase III Randomized Non-Inferiority Study of OSS Versus PEG + Electrolyte Colonoscopy Preparation in Adolescents.

OBJECTIVES: Many protocols and preparations are used for bowel cleansing before pediatric colonoscopy but few are based on scientific evidence. We evaluated efficacy, safety, tolerability, and patient preference of oral sulfate solution (OSS) at 75% of the adult dose versus polyethylene glycol (PEG)-electrolyte solution in adolescents presenting for diagnostic colonoscopy. METHODS: Phase III, randomized, evaluator-blinded, non-inferiority study of OSS and PEG in adolescents aged 12-17 years. OSS and PEG were administered in 2 doses on the day before colonoscopy. Primary endpoint included proportion of patients with successful overall preparation (4-point scale). Secondary endpoints included overall and segmental bowel cleansing (Boston Bowel Preparation Scale; BBPS), completed colonoscopies, duration of examination, time to cecal intubation, proportion of nasogastric tubes (NGTs), adverse events (AEs) and acceptability. RESULTS: Successful cleansing was achieved in 71.4% and 79.0% of patients receiving OSS and PEG, respectively [adjusted difference -7.61 (95% confidence interval, CI, -18.45 to 3.24); P = 0.0907]. Segmental BBPS score for the left and transverse colon were similar between treatment groups, but better for the right colon with PEG than OSS [2.2 (95% CI, 2.0-2.4) and 1.9 (95% CI, 1.7-2.1), respectively; P = 0.0015]. Significantly fewer OSS patients needed NGT placement to ingest the whole solution [9/125 (7.2%)] than PEG patients [36/116 (31.0%); P < 0.0001]. Treatment acceptability was significantly higher with OSS than PEG ( P < 0.0001). Duration of examination, completed colonoscopies, and time to cecal intubation were similar between preparations. Gastrointestinal AEs including nausea, vomiting, abdominal pain, and distension were similar in both groups but more patients receiving PEG had AEs assessed as incapacitating. CONCLUSIONS: Non-inferiority of OSS to PEG was not demonstrated, but OSS was associated with a lower requirement for NGT, better acceptability, and less frequent severe AEs than with PEG.

The Precision Allergy Molecular Diagnosis (PAMD@) in Monitoring the Atopic March in a Child with a Primary Food Allergy: Case Report.

The case of a 9-month-old boy with an initial diagnosis of atopic dermatitis and confirmed allergy to hen's egg, cow's milk allergens with episodes of anaphylaxis who developed birch allergy whilst under observation with asthma symptoms was presented. The precision allergy molecular diagnosis (PAMD @) allowed for individualisation of dietary recommendations and observing the early progression of food sensitisation to the main birch molecule. The presented identification of major allergic molecules with PAMD@ in the preclinical phase of asthma contributes to the discussion related to early specific immunotherapy to suppress molecular spread and allergic march. However, more research is needed to verify this hypothesis.

Assessment of induction therapy with infliximab in children with moderate to severe ulcerative colitis: a multi-center study.

THE AIM OF THE STUDY: Assessment of clinical and endoscopic efficacy of induction therapy with infliximab in children with ulcerative colitis. MATERIAL AND METHODS: This is a retrospective analysis of medical records of pediatric patients with moderate to severe UC who had received at least one infusion of infliximab in Polish pediatric academic clinical centers from 2003 to 2013. The primary endpoint was clinical remission rate at week 10, (PUCAI score <10 points) while the secondary endpoints were: clinical response rate (>19-points decrease in PUCAI), mucosal response rate (defined as an improvement of the Baron score), and mucosal healing rate (Baron score 0 or 1). RESULTS: 44 patients, at mean age of 14±3.9 years, were included into the study. 38 (86%) patients completed induction therapy regimen with infliximab and were finally included into the analysis. Clinical response and remission rates at week 10 there were 36% and 25% respectively. There was significant drop of PUCAI (58.31±15.5 vs. 24.23±23.83) and Baron score (2.63±0.49 vs. 1.44±0.99) at this time point. Mucosal response and mucosal healing rate were 57% and 48% respectively. Infliximab failure defined as non-clinical and non-mucosal response at week 10, occurred in 16 patients. Infliximab-associated adverse events occurred in 3 patients, with all severe hypersensitivity reactions to infliximab. CONCLUSIONS: Infliximab induction therapy was safe and effective in Polish moderate to severe UC pediatric patients with 50% rate of mucosal improvement. However, clinical response rate was lower than previously reported.

High- versus low-volume polyethylene glycol plus laxative versus sennosides for colonoscopy preparation in children.

OBJECTIVE: Many protocols of bowel preparation are available for use in children; however, none of them is commonly accepted. The aim of the study was to evaluate the efficacy and acceptability of high-volume polyethylene glycol (PEG) versus low-volume PEG combined with bisacodyl (BPEG) versus sennosides for colonoscopy preparation in children. METHODS: Participants ages 10 to 18 years were randomly assigned to receive either PEG 60 or PEG 30 mL kg⁻¹ day⁻¹ plus oral bisacodyl 10 to 15 mg/day or sennosides 2 mg kg⁻¹ day⁻¹ for 2 days. A blinded assessment of bowel cleansing was made by the endoscopist according to the Aronchick and Ottawa scales. Patient acceptability was evaluated with the visual-analog scale. Analysis was done on an available case analysis basis. RESULTS: Of 240 patients enrolled in the study 234 patients were available for analysis of the efficacy of colon cleansing. There were no significant differences found among the 3 groups for the proportions of participants with excellent/good (PEG: 35/79, BPEG: 26/79, sennosides 25/76) and poor/inadequate (PEG: 20/79, BPEG: 28/79, sennosides 28/76) bowel preparation evaluated with the Aronchick scale and for the mean Ottawa total score (PEG: 5.47 ±â€Š3.63, BPEG: 6.22 ±â€Š3.3, sennosides: 6.18 ±â€Š3.53). Acceptability of bowel cleansing protocol was similar in all of the groups (P = 0.8). CONCLUSIONS: All 3 cleansing methods showed similar efficacy and tolerability; however, none of them was satisfactory.