Maria Kotowska

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.

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;)

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.

Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine in Pediatric Patients with Inflammatory Bowel Disease.

Background:There are only a few studies on immune response to pneumococcal vaccines in patients with inflammatory bowel disease (IBD); all of them assessed polysaccharide vaccines only. The aim of the study was to evaluate the immunogenicity and safety of 13-valent pneumococcal conjugate vaccine (PCV13) in IBD pediatric patients compared with healthy controls. Methods:This was a multicenter, prospective, and controlled study on children and adolescents aged 5 to 18 years with IBD with no history of pneumococcal immunization. The subjects for the study belonged to one of the following groups: patients with IBD on no immunosuppressive therapy (group A), those on tumor necrosis factor agents or immunomodulators (group B), and healthy controls (group C). The study population received 1 intramuscular injection of PCV13. The primary outcome measure was adequate vaccine response defined as postvaccination titer ≥0.35 &mgr;g/mL to all 13 serotypes. Geometric mean titers and geometric mean titer rises were measured for all serotypes. The evidence of local and systemic adverse effects for 5 days after the vaccine was registered. Results:A total of 178 subjects (122 patients and 56 controls) completed the study course. There was no significant difference in the rate of adequate vaccine response between patients with IBD and controls measured 4 to 8 weeks after vaccination (90.4% versus 96.5%, P = 0.5281). Children in group A had higher geometric mean titer rises than children in group B (P = 0.0369). There were no serious adverse events related to PCV13 during the study. Conclusions:PCV13 is both immunogenic and safe in pediatric patients with IBD.

Indirect effects of a 7 year PCV7/PCV13 mass vaccination program in children on the incidence of pneumonia among adults: a comparative study based on two Polish cities.

Abstract Background and objectives: In 2006 the city of Kielce, Poland, introduced a mandatory PCV7 (replaced by PCV13 in 2011) vaccination program against S. pneumoanie for all children under 2 years old. At that time, the neighboring city of Ostrowiec Świętokrzyski had no such large-scale vaccination program in place. This created an opportunity to observe the results of the vaccination by comparing the incidence of pneumonia in these two cities. The aim of this study was to analyze how the incidence of pneumonia among adults was indirectly affected by the PCV7/PCV13 vaccination program in children during the 7 year follow-up period. Methods: We performed a retrospective study. PCV7/PCV13 vaccinations were delivered according to a 2 + 1 schedule. The vaccination rate in the analyzed period amounted to almost 99%. The following age groups were analyzed: 30–49, 50–64 and 65+. The Cochran–Armitage test was used to investigate the significance of the observed trend in pneumonia morbidity. The significance of deviations from a linear trend was also tested. In addition, the importance of the trend (in the case of deviations from linearity) was confirmed with the use of the Mantel test. Results: In the 65+ age group there was a decrease of 66.5% in the incidence of diagnosed pneumonia (p < 0.0001). This was followed by smaller, but statistically significant, declines in the other age groups: 30.75% in the 30–49 age group (p = 0.001) and 56.8% in the 50–64 age group (p < 0.0001). This decreasing trend continued for seven consecutive years of observation. In addition, we demonstrated a statistically significant higher rate of pneumonia in all age groups in the City of Ostrowiec Świętokrzyski. Conclusions: The results clearly indicate that the indirect effectiveness of the PCV7/PCV13 vaccine program, performed according to the 2 + 1 schedule and applied in Kielce, Poland, is statistically significant.

Value of Antral Nodularity for the Diagnosis of Helicobacter pylori Infection in Children

Background The aim of this study was to confirm the role of antral nodularity in the diagnosis of Helicobacter pylori (H. pylori) infection in children. Material/Methods This prospective study included 107 children (58 male; 54.2%), between the ages of 3 and 18 years, infected with H. pylori, which was confirmed if the patient had at least 2 of 4 positive test results (urea breath test, urease test in gastric biopsy, histopathology – positive hematoxylin and eosin and Giemsa staining, and/or monoclonal stool ELISA test – Amplified IDEIA™ Hp StAR™). The control group consisted of 234 children with abdominal pain, of similar age, in whom urease test in gastric tissue and histopathology were negative. In both groups, photographs of the gastric antrum taken during endoscopy were evaluated for nodularity by 3 independent endoscopists, blinded to the results of other tests. Sensitivity, specificity, and negative and positive predictive value of nodularity were assessed. Indication for upper endoscopy was chronic abdominal pain not considered to be functional. Results There were no statistical differences between groups regarding sex (chi-square test with Yates’s correction: p=0.8763) or age (mean ±SD) 11.77±3.49 and 12.43±3.32, study and control groups, respectively (Mann-Whitney test: p=0.1352). The sensitivity of the presence of nodularity as an indication of H. pylori infection was 91.6% and specificity was 91%. PPV of gastric nodularity was 81% and NPV was 96%. Conclusions Antral nodularity is reliable test. Physicians could start treatment of H. pylori infection whenever gastric nodularity is observed and the urease test result is positive, without waiting for histopathology results.

Dotychczasowe doświadczenia i obserwacje ze szczepieniami za pomocą skoniugowanych szczepionek przeciwpneumokokowych w schemacie 2+1 ☆

Streszczenie W pracy podsumowano dotychczasowy stan wiedzy nad efektami klinicznymi szczepien skoniugowanymi szczepionkami pneumokokowymi (PCV7, PCV10 i PCV13) w schemacie 2+1 oraz dostepne dane porejestracyjne dla szczepionki PCV7. Przedstawione badania wskazują na efektywnośc schematu 2+1 w szczepieniach populacyjnych dla PCV7 i dobrą immunogennośc PCV10 i PCV13 w tym samym schemacie. Dla obu tych nowych szczepionek brak jest jednak jeszcze badan populacyjnych, ktore wykazalyby, jak w praktyce immunogennośc przeklada sie na efektywnośc, co jak uczy doświadczenie, nie zawsze musi byc rownoznaczne, gdyz w stosunku do roznych serotypow i chorob wywolywanych przez pneumokoki stezenia ochronne przeciwcial nie są takie same.

Kliniczne i praktyczne efekty szczepień skoniugowaną szczepionką pneumokokową w zapobieganiu inwazyjnej chorobie pneumokokowej, zapaleniom płuc i ucha środkowego u dzieci w świetle doświadczeń światowych i polskich

Streszczenie Cel W pracy przedstawiono polskie i światowe doświadczenia blisko 10-letniego stosowania skoniugowanej szczepionki pneumokokowej w zapobieganiu inwazyjnej chorobie pneumokokowej, zapaleniom pluc i ucha środkowego. Omowiono takze bezpośrednie i pośrednie efekty powszechnych szczepien przeciwpneumokokowych. Wskazano rowniez na obecne i przyszle ekonomiczne korzyści masowych szczepien przeciwpneumokokowych.