Piotr Albrecht

Saccharomyces boulardii in the prevention of antibiotic‐associated diarrhoea in children: a randomized double‐blind placebo‐controlled trial

Background : Co‐treatment with Saccharomyces boulardii appears to lower the risk of antibiotic‐associated diarrhoea in adults receiving broad‐spectrum antibiotics.

Randomized, Double-blind, Placebo-controlled Trial : Effect of Lactobacillus GG Supplementation on Helicobacter Pylori Eradication Rates and Side Effects During Treatment in Children

Objective: To determine the effectiveness of Lactobacillus GG (LGG) in children with Helicobacter pylori infection undergoing eradication therapy. Materials and Methods: We conducted a double-blind, placebo-controlled, randomized trial comparing a 7-day, triple eradication regimen consisting of 2 antibiotics (amoxicillin tablets, 25 mg/kg twice per day, and clarithromycin tablets, 10 mg/kg twice per day) plus a proton pump inhibitor (omeprazole capsules, 0.5 mg/kg twice per day) supplemented with LGG (109 colony-forming units) or placebo in 83 children with H pylori infection confirmed by 2 of 3 tests (13C-urea breath test, histopathology, rapid urease test). The primary outcome measure was the H pylori eradication rate. The secondary outcome measure was the proportion of patients who experienced therapy-related adverse effects during anti–H pylori treatment. Results: The groups did not differ with respect to H pylori eradication rates. Of the 34 children in the LGG group, 23 (69%) experienced eradication, compared with 22 of 32 children (68%) in the placebo group (RR 0.98, 95% CI 0.7–1.4). The groups did not differ with respect to adverse effects. Conclusions: In children with H pylori infection, supplementation of standard triple therapy with LGG did not significantly alter the eradication rate or side effects.

Extensive and Partial Protein Hydrolysate Preterm Formulas: The Effect on Growth Rate, Protein Metabolism Indices, and Plasma Amino Acid Concentrations

Background The use of protein hydrolysate preterm formulas is restricted because data on their nutritional adequacy are scarce. The authors evaluated the rate of growth and indices of protein metabolism in low-birth weight infants fed extensive and partial protein hydrolysate preterm formula followed for 12 weeks. Methods A total of 61 low-birth weight infants were assigned randomly to receive extensive protein hydrolysate preterm formula (EH; n = 16), partial protein hydrolysate preterm formula (PH; n = 15), and standard preterm formula (SF; n = 15), or were fed their own mothers fortified breast milk (FBM; n = 15). The infants were investigated at study entry, and at 4, 8, and 12 weeks after study entry. Results There were no differences with respect to growth rate (weight gain, increments in length and head circumference), urea, albumin, prealbumin, transferrin, and plasma amino acid concentrations (except for tyrosine on a single occasion) according to the degree of hydrolysis. There were also no differences between groups fed hydrolyzed formulas and SF. However, several differences were found when EH and PH were compared with FBM. Weight gain from the entry to 12 weeks, serum urea at 12 weeks, and total plasma essential amino acids at 8 weeks were significantly higher in groups fed EH and PH than in those fed FBM. In addition, valine was significantly higher in groups fed PH (P < 0.05) than in the group fed FBM at 8 and 12 weeks, tyrosine was higher in EH and PH in comparison with FBM at 4 weeks, and in PH versus FBM at 12 weeks after study entry. Conclusions This study suggests that experimental EH and PH are at least nutritionally equivalent to SFs.

Immunogenecity of hepatitis A vaccine in pediatric patients with inflammatory bowel disease.

Background: There are only a few studies on immune response to routine vaccinations in children with inflammatory bowel disease (IBD), despite a strong need for this kind of study. The aim of the study was to evaluate the immunogenicity of an inactivated hepatitis A vaccine (HAV) in IBD pediatric patients compared with healthy controls. Methods: This was an open, prospective, and controlled study on anti‐HAV‐negative children and adolescents age 2‐18 years with IBD. HAV using 720 enzyme‐linked immunosorbent assay (ELISA) units were administered at 0 months and at 6‐12 months. Seroconversion and geometric mean titers were measured after each vaccine dose. The evidence of local and systemic adverse effects for 3 days after the first and second dose of vaccine was registered. Results: A total of 134 subjects (66 patients and 68 controls) completed the whole study course consisting of two doses of vaccine and six serum samples. There was no significant difference in the rate of seroconversion between IBD patients and controls when measured after the second dose of vaccine (97% versus 100%, P = 0.2407), but the rate was significantly lower in the IBD group when measured after the first dose (39% versus 64%, P = 0.00001). The mean geometric titers were statistically significantly lower in the IBD group than in the control group at all of the measured timepoints. There were no serious adverse events related to HAV during the study. Conclusions: HAV is both immunogenic and safe in pediatric patients with IBD. (Inflamm Bowel Dis 2010;)

Epidemiology of inflammatory bowel disease among children in Poland. A prospective, population-based, 2-year study, 2002-2004.

Background/Aims: The incidence of pediatric inflammatory bowel disease (IBD) in Western countries is on the rise. No prospective studies have been conducted on the epidemiology of pediatric IBD in Poland. The aim of the study was to define the characteristics of new pediatric IBD and assess the incidence of new IBD among children in Poland between 2002 and 2004. Methods: Patient records from 24 pediatric gastroenterology centers servicing the whole population of Poland were collected. IBD diagnosis was based on clinical, radiological, endoscopic and histological features. Results: There were 491 new IBD patients, representing an overall incidence of IBD of 2.7 cases/100,000 children/year. The incidence of Crohn’s disease (CD) was 0.6, ulcerative colitis (UC) 1.3, and indeterminate colitis (IC) 0.8. The age-related incidence of IBD was 1.8 in the 0- to 10-year-old age group, rising to 3.7 for the 11- to 18-year age group. Conclusions: The overall incidence of IBD (as well as CD, UC and IC) in Poland is lower than that in Western countries. The relative contribution of UC and IC to the overall IBD incidence is higher in Poland than in most Western countries. These findings may suggest a tendency towards under- or misdiagnosis.

Sequential therapy compared with standard triple therapy for Helicobacter pylori eradication in children: a double-blind, randomized, controlled trial.

OBJECTIVE To determine the effectiveness of sequential therapy compared with standard triple therapy for Helicobacter pylori eradication in children. STUDY DESIGN In 107 children with H pylori infection confirmed with 2 of 3 tests ((13)C-urea breath test, histopathology, rapid urease test), we conducted a double-blind, randomized, controlled trial comparing a sequential treatment (amoxicillin and omeprazole for 5 days followed by clarithromycin, tinidazole, and omeprazole for 5 days) to a 7-day standard triple eradication regimen (amoxicillin and clarithromycin plus omeprazole) followed by placebo for 3 days. RESULTS In the experimental group (n=52) compared with the control group (n=51), there was a significant difference in the H pylori eradication rate at 6 to 8 weeks after the completion of treatment (primary outcome), as confirmed with negative results on (13)C-urea breath test (45/52 or 86.5% versus 35/51 or 68.6%; relative risk, 1.26; 95% CI, 1.02-1.60). Groups did not differ in any of the secondary outcomes (ie, adverse effects, the need for discontinuation of the H pylori therapy, compliance with therapy). CONCLUSIONS In children with H pylori infection, sequential eradication therapy compared with standard triple therapy resulted in a higher eradication rate, although the difference was of borderline statistical significance.

The role of dietary fibre in inflammatory bowel disease.

The aetiology of inflammatory bowel diseases (IBD), which are primarily Crohns disease and ulcerative colitis, still remains unclear, while the incidence of IBD is constantly increasing, especially in the industrialised countries. Among genetic, environmental, and immunological factors, changes in the composition of the intestinal microflora and diet are indicated as very important in initiating and sustaining inflammation in patients with IBD. Above all nutrients dietary fibre is an especially important component of diet in the context of IBD. A potentially protective effect of high-fibre diet on intestinal disorders was described as early as in 1973. Several trials performed in animal models of IBD and human studies have reported that supplementation of some types of dietary fibre can prolong remission and reduce lesions of the intestinal mucosa during the course of the disease. This paper presents the current state of knowledge on the effects of dietary fibre in IBD.

Phase 3 trial evaluating the immunogenicity, safety, and tolerability of manufacturing scale 13-valent pneumococcal conjugate vaccine

13-valent pneumococcal conjugate vaccine (PCV13) includes polysaccharide conjugates from six pneumococcal serotypes in addition to those in the licensed 7-valent vaccine, thereby offering expanded protection against pneumococcal disease. The phase 3 trial reported here was conducted per a regulatory requirement to evaluate the immunogenicity, safety, and tolerability of two lots of the final PCV13 formulation that differed with respect to production scale but not the manufacturing process. The anti-pneumococcal polysaccharide immunogenicity and safety/tolerability were found to be similar between the two PCV13 vaccine lots.

Invasive pneumococcal disease in children up to 5 years of age in Poland

Streptococcus pneumoniae is one of the leading pathogens causing invasive disease in children worldwide. We have previously published a study on nasopharyngeal carriage in children from different settings in Poland [1]. Here, we present results of the prospective study on laboratoryconfirmed invasive pneumococcal disease (IPD) and S. pneumoniae serotype distribution in children up to 5 years of age in Poland. Objectives

Enterotoxigenic Clostridium perfringens infection and pediatric patients with inflammatory bowel disease.

BACKGROUND AND AIMS Clostridium difficile is the major cause of antibiotic-associated diarrhea and is the most well known bacterial pathogen associated with inflammatory bowel disease (IBD). Enterotoxigenic Clostridium perfringens has also been detected in up to 15% of antibiotic-associated diarrhea cases, and it has not been found in healthy people. The aim of this study was to investigate the prevalence of C. perfringens infection in pediatric patients with IBD. METHODS This was a prospective, controlled study evaluating pediatric IBD patients in the Department of Pediatric Gastroenterology and Nutrition in Warsaw, Poland. All of the patients were diagnosed according to the Porto criteria. There were two control groups: (1) non-IBD patients that were suspected for bacterial diarrhea and (2) healthy children. Stool samples were collected on the day of admission. C. perfringens infection diagnosis was based on a positive stool enzyme immunoassay (C. perfringens enterotoxin test kit TechLab). RESULTS 91 fecal specimens from patients with IBD were collected. The average patient age was 11.7 years in IBD group, 7.4 years in non-IBD patients with diarrhea, and 7.4 years in healthy children. The prevalence of C. perfringens infection was 9% (8/91; CI 95% 4.6-16.4). There were more Crohns patients (6/8) in the C. perfringens positive group. There was no C. perfringens infection in the two control groups. CONCLUSION Our pilot data add evidence to the hypothesis that Clostridia other than C. difficile may play a significant role in the clinical course of IBD. However, further studies are needed to confirm this.