Mixed Strain H. Pylori Infection in Patients Who Have Problems With Eradication of H. Pylori
16 juillet 2010 mis à jour par: University Medical Centre Ljubljana
Multi Locus Sequence Typing (MLST) Used as Tool to Confirm Ability of Susceptible Helicobacter Pylori Strains to Gain Resistance to Clarithromycin During Eradication Therapy Independently of Mixed Strain Helicobacter Pylori Infection
The purpose of this study is to determine whether mixed H. pylori strain infection is the reason for eradication failure during treatment of H. pylori infection.
The investigators present the results got from extensive sampling of biopsy samples taken from individuals diagnosed with H. pylori connected disease.
The investigators were looking for individuals that were not able to eradicate H. pylori although they had susceptibility testing tailored antibiotic therapy.
On their control visit after 2 months they presented again with H. pylori although at their first visit they had H. pylori isolated from biopsy sample sensitive to all antibiotics prescribed.
Multi Locus Sequence Typing (MLST) was used to prove the sequence type of H. pylori and E test was used to determine susceptibility of H. pylori to antibiotics.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Observationnel
Inscription (Réel)
10
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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-
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Ljubljana, Slovénie, 1000
- Institute of microbiology and immunology
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
The investigators invited people who were not able to eradicate H. pylori although at their first visit they had H. pylori sensitive to all antibiotics tested.
At first visit all patients had stomach biopsy sample taken and H. pylori isolated and therapy prescribed.
If they did not eradicate bacteria after 2 months they were again invited to control visit to define the problem and appropriate therapy prescribed.
They were again invitation to control visit at the end of June 2010 to see the outcome of therapy.
La description
Inclusion Criteria:
- People who have H. pylori sensitive to all antibiotics before therapy and and do not eradicate H. pylori after appropriate antibiotic therapy.
Exclusion Criteria:
- People who did not eradicate H. pylori because of primary resistance to antibiotics.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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H. pylori eradication failure
People who are not able to eradicate H. pylori although the appropriate antibiotic therapy taken.
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Amoxicillin, metronidazole and tetracyclin as primary drugs to treat H. pylori infection in duration of 10 days.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Sequence type of H.pylori determined with MLST as a good evidence that people are infected with only one strain of H. pylori
Délai: Six months after first visit the strains from before/after therapy will be inspected with MLST to see if people have mixed strain infection.
|
The investigators assume that people that are not able to eradicate infection with H. pylori although they have never been treated for such infection and they have taken appropriate therapy, have such problems because H. pylori is capable to escape from immune response.
The investigators will define if patients have the same H. pylori sequence type through longer period and that such H. pylori is capable to develope resistance to clarithromycin very quickly.Such patients can eliminate H. pylori if we check the infection status more often and give them more suitable antibiotic therapy.
|
Six months after first visit the strains from before/after therapy will be inspected with MLST to see if people have mixed strain infection.
|
|
Sequence type of H.pylori determined with MLST as a good evidence that people are infected with only one strain of H. pylori
Délai: 9 months after first visit to see if people still have H. pylori due to insufficient immune response.
|
The investigators assume that people that are not able to eradicate infection with H. pylori although they have never been treated for such infection and they have taken appropriate therapy, have such problems because H. pylori is capable to escape from immune response.
The investigators will define if patients have the same H. pylori sequence type through longer period and that such H. pylori is capable to develope resistance to clarithromycin very quickly.Such patients can eliminate H. pylori if we check the infection status more often and give them more suitable antibiotic therapy.
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9 months after first visit to see if people still have H. pylori due to insufficient immune response.
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Alojz Ihan, MD. PhD, Institute of mircobiology and immunology, Slovenia
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 novembre 2008
Achèvement primaire (Réel)
1 décembre 2009
Achèvement de l'étude (Réel)
1 juillet 2010
Dates d'inscription aux études
Première soumission
13 juillet 2010
Première soumission répondant aux critères de contrôle qualité
16 juillet 2010
Première publication (Estimation)
19 juillet 2010
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
19 juillet 2010
Dernière mise à jour soumise répondant aux critères de contrôle qualité
16 juillet 2010
Dernière vérification
1 juillet 2010
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IMI2010-2
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