Valeriu V. Lupu

Helicobacter pylori infection and gastroesophageal reflux in children

Some studies suggest that Helicobacter pylori (H. pylori) infection would be a protective factor for the gastroesophageal reflux. The aim of this study was to explore this fact. A group of 72 children, admitted in a pediatric gastroenterology regional center in Northeast Romania, diagnosed with gastroesophageal reflux by 24-hour continuous esophageal pH monitoring (results were interpreted using the Boix-Ochoa score), underwent upper endoscopy with gastric biopsy to detect the presence of H. pylori by the rapid urease testing and for bacteriological and histologic examination. 19 children (26.39%) had H. pylori infection, while 53 (73.61%) did not. The grade of esophagitis was classified according to the Los Angeles classification system. Out of 47 children with esophagitis A, 16 (34.04%) had H. pylori infection, while out of the 25 children with esophagitis B, only 3 (12%) had H. pylori infection, with statistic significance (χ2 = 54.69, P << 0.05, 95% confidence interval [CI]). Regarding the value of the Boix-Ochoa score, it appears that the presence of the H. pylori determines lower pH-metry scores (F = 8.13, P = 0.0015, 95% CI). The presence of the H. pylori was not an important factor in the gastroesophageal reflux. On the other hand its relationship with esophagitis appears to be inverse ratio. The fact that the H. pylori presence is statistically greater in the grade A esophagitis could confirm the hypothesis that the bacteria would slow down the development of the esophagitis.

Effects of prophylactic ibuprofen and paracetamol administration on the immunogenicity and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugated vaccine (PHiD-CV) co-administered with DTPa-combined vaccines in children: An open-label, randomized, controlled, non-inferiority trial

ABSTRACT Prophylactic paracetamol administration impacts vaccine immune response; this study (www.clinicaltrials.gov: NCT01235949) is the first to assess PHiD-CV immunogenicity following prophylactic ibuprofen administration. In this phase IV, multicenter, open-label, randomized, controlled, non-inferiority study in Romania (November 2010–December 2012), healthy infants were randomized 3:3:3:1:1:1 to prophylactically receive immediate, delayed or no ibuprofen (IIBU, DIBU, NIBU) or paracetamol (IPARA, DPARA, NPARA) after each of 3 primary doses (PHiD-CV at age 3/4/5 months co-administered with DTPa-HBV-IPV/Hib at 3/5 and DTPa-IPV/Hib at 4 months) or booster dose (PHiD-CV and DTPa-HBV-IPV/Hib; 12–15 months). Non-inferiority of immune response one month post-primary vaccination in terms of percentage of infants with anti-pneumococcal antibody concentrations ≥0.2 µg/mL (primary objective) was demonstrated if the upper limit (UL) of the 98.25% confidence interval of difference between groups (NIBU vs IIBU, NIBU vs DIBU) was <10% for ≥7/10 serotypes. Immunogenicity and reactogenicity/safety were evaluated, including confirmatory analysis of difference in fever incidences post-primary vaccination in IBU or DIBU group compared to NIBU. Of 850 infants randomized, 812 were included in the total vaccinated cohort. Non-inferiority was demonstrated for both comparisons (UL was <10% for 9/10 vaccine serotypes; exceptions: 6B [NIBU], 23F [IIBU]). However, fever incidence post-primary vaccination in the IIBU and DIBU groups did not indicate a statistically significant reduction. Prophylactic administration (immediate or delayed) of paracetamol decreased fever incidence but seemed to reduce immune response to PHiD-CV, except when given only at booster. Twenty-seven serious adverse events were reported for 15 children; all resolved and were not vaccination-related.