Early this year, an article reporting the results of a European Consensus Conference on the Management of Helicobacter pylori infection in children was published in this journal (1). The majority of statements regarding the diagnostic methods to be used when infection is suspected, and which children should be treated, were quite similar to those reported in an analogous conference held in Canada in the previous year (2) and to those recently published as a medical position statement of the North American Society for Pediatric Gastroenterology and Nutrition (NASPGN) (3) except for one important issue: how to treat children with the infection.
The Canadians suggested a 2-week course of a triple therapy encompassing a proton pump inhibitor plus two antibiotics, the North Americans triple or quadruple therapies given for 1 or 2 weeks, whereas the European group thought that there are not enough strong data in published studies to support a consensus. The few studies available for analysis have several limitations, and, in particular, all data come from open studies, because no randomized or double-blind studies in the pediatric population are available. Furthermore, a recent review on this issue, although based on small series, came to the conclusion that, in children, dual therapies could be as effective as triple therapies (providing the resistance rate of H. pylori remains low in that area) and also that longer courses of proton pump inhibitor-based triple therapies do not seem to be better than shorter duration ones (4).
Treatment studies involving large series of children are necessary but multicenter European studies are difficult to implement because of the following: 1) funding problems (pharmaceutical companies usually work on national budgets), 2) varying drug availability in different countries, 3) different availability of pediatric forms in various countries and packages for children are often missing, 4) lack of data on antibiotic resistance in many countries, and 5) concern about placebo-controlled studies in children.
The combined efforts of the European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) members and the European Helicobacter pylori Study Group (EHPSG) resulted in creating a “task force” of European pediatric gastroenterologists (approximately one from each European country) who held regular annual meetings. A meeting was held in Tuusula (Finland) with epidemiologists and microbiologists in October 1999 to discuss the problem. It was thought that data on a large series of children should be collected through a register in which each investigator who is treating Helicobacter-infected children can choose the treatment schedule, implement it, and provide results to be analyzed by the group. The idea of creating a register to collect all data on treatment from each pediatrician, suggested by F. Gottrand, was extensively discussed, and was approved by the “steering committee” of the group (S. Cadranel, B. Drumm, S. Koletzko, and G. Oderda). Instructions on how to build the register with all of the data needed were sent to M. Lentze who created the register, which is now available on the ESPGHAN Web site.
The aims of the project are to collect data on efficacy of different regimens with comparable protocols, to find out what is practiced in the field, and to subsequently try to reach a consensus on treatment. Because bias in the data collected by the register cannot be excluded, they will be interpreted with caution. All ESPGHAN members or any European pediatrician, sponsored by an ESPGHAN member, who are treating Helicobacter pylori-infected children are invited to use the register.
Inclusion criteria to enter data on treatment given are the following:
- Children to be treated should be younger than 14 years.
- The treatment regimen should be chosen from among those suggested.
- Duration of treatment should be 1 or 2 weeks.
- Each child should be entered as a consecutive number for each center.
- All data requested by the register must be provided.
- Endoscopy and histology on gastric antrum and gastric body must be performed at entry (before any treatment is planned).
- Susceptibility testing before therapy is suggested but not mandatory.
- If a “second” treatment is planned, endoscopy, histology, and culture on gastric antrum and gastric body with sensitivity profile of H. pylori to Clarithromycin and Metronidazole is highly warranted (1).
- Follow-up data (histology or 13 C–urea–breath test) should be collected at least 4 weeks or more after the end of treatment.
- Only prospective data will be accepted (or treatment started after January 2001).
- Informed and signed consent from the parents for the anonymous use of their children's data must be obtained. (This could be obtained with the consent to perform endoscopy.)
- Access to Internet and to the ESPGHAN Web site is necessary.
Only descriptive analyses will be made, considering a nonrandomized design. Comparison between different treatment schedules will be made by means of the exact test based on the comparison between proportion of eradication. Crude and corrected analyses will be carried out. In the adjusted model, age, gender, area of residence, and area of birth will be included as covariate variables. Stratified analyses according to nationality will be carried out.
The register is protected by passwords: one for each pediatrician to enter data, a different one for investigators to read and analyze collected data. The register is available at the following address: http://www.meb.uni-bonn.de/espghan/. To access the site, a password and an identification number must be requested from Professor Michael Lentze by e-mail at his address: email@example.com. The authors thank all pediatricians willing to cooperate.
1. Drumm B, Koletzko S, Oderda G, et al. Helicobacter pylori
infection in children. Report of a consensus conference held in Budapest, September 1998. J Pediatr Gastroenterol Nutr 2000; 30: 207–13.
2. Canadian Helicobacter
Study Group. Consensus conference on the approach to Helicobacter pylori
infections in children and adolescents. Can J Gastroenterol
3. Gold B, Colletti RB, Abbott M, et al. Helicobacter pylori
infection in children: Recommendations for diagnosis and treatment. J Pediatr Gastroenterol Nutr 2000; 31: 490–7.
4. Oderda G, Rapa A, Bona G. A systematic review of Helicobacter pylori
eradication treatment schedules in children. Aliment Pharmacol Ther 2000; 14 (suppl 3): 1–8.