Overview

Efficacy of Acetilcysteine in 'Rescue' Therapy for Helicobacter Pylori Infection. Pilot Study

Status:
Unknown status

Trial end date:
2009-09-01

Target enrollment:
0

Participant gender:
All

Summary

H pylori gastric infection is one of the most prevalent infectious diseases worldwide. The discovery that most upper gastrointestinal diseases are related to H pylori infection and therefore can be treated with antibiotics is an important medical advance. Currently, a first-line triple therapy based on proton pump inhibitor (PPI) or ranitidine bismuth citrate (RBC) plus two antibiotics (clarithromycin and amoxicillin or nitroimidazole) is recommended by all consensus conferences and guidelines. Even with the correct use of this drug combination, infection can not be eradicated in up to 23% of patients. Therefore, several second line therapies have been recommended. A 7 d quadruple therapy based on PPI, bismuth, tetracycline and metronidazole is the more frequently accepted. However, with second-line therapy, bacterial eradication may fail in up to 40% of cases. When H pylori eradication is strictly indicated the choice of further treatment is controversial. When available, endoscopy with culture and consequent antibiotic susceptibility testing remains the most appropriate option for patients with two eradication failures to avoid a widespread use of expensive antibiotics. The use of these drugs may also induce severe side-effects and development of H pylori resistant strains. Resistant strains of Helicobacter pylori can display a dense biofilm with mucus and microorganisms in a coccoid shape on the mucosal surface of stomach that may have a role in determining the resistance to the antibiotic therapies. Possibly, N-acetil-cysteine (NAC) may dissolve biofilm architecture and help to eradicate resistant strains of H pylori.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Catholic University of the Sacred Heart

Treatments:

Anti-Bacterial Agents
Antibiotics, Antitubercular

Criteria

Inclusion Criteria:

- Both genders

- Age > 18 years

- Persistent infection from Helicobacter pylori, at gastroscopy or 13C urea breath test,
after at least two antibiotic unsuccessful eradication attempts

Exclusion Criteria:

- Verified allergies to the acetylcysteine or to the antibiotics to cure Helicobacter
pylori

- Pregnancy, nursing