Helicobacter Pylori Infection | Efficacy of Acetilcysteine in 'Rescue' Therapy for Helicobacter Pylori Infection. Pilot Study
Helicobacter Pylori Infection research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Helicobacter Pylori Infection
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Group A: NCA 600 mg+antibioticsNCA 600mg once a day for a week and subsequently a culture-guided one-week regimen including a PPI plus two antibiotics
Drug:Group B: antibiotic treatment (control)patients receiving solely a culture-guided one-week antibiotic treatment including a PPI plus two antibiotics
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Group B: antibiotic treatment (control)patients receiving solely a culture-guided one-week antibiotic treatment including a PPI plus two antibiotics
Group A: NCA 600mg +antibioticsNCA 600mg once a day for a week and subsequently a culture-guided one-week regimen including a PPI plus two antibiotics
Start Date: April 2009
Completed Date: September 2009
Phase: Phase 2
Primary Outcome: To evaluate the usefulness of NAC as pre-treatment attempt associated with a culture-guided antibiotic therapy as rescue therapy after multi-attempts antibiotic failure
Study sponsors, principal investigator, and references
Principal Investigator: Giovanni Cammarota, MD
Lead Sponsor: Catholic University of the Sacred Heart