Efficacy of Acetilcysteine in 'Rescue' Therapy for Helicobacter Pylori Infection. Pilot Study
Information source: Catholic University of the Sacred Heart
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Helicobacter Pylori Infection
Intervention: Group A: NCA 600 mg+antibiotics (Drug); Group B: antibiotic treatment (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Catholic University of the Sacred Heart Official(s) and/or principal investigator(s):
Giovanni Cammarota, MD, Principal Investigator, Affiliation: Catholic University, Institute of Internal Medicine
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.
Clinical Details
Official title: Efficacy of Acetilcysteine in 'Rescue' Therapy for Helicobacter Pylori Infection. Pilot Study
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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
Detailed description:
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, 20 patients,
after at least two antibiotic unsuccessful eradication attempts for H pylori, will be
consecutively recruited. In all patients antibiotic susceptibility testing will be
performed. Patients will be randomized in two groups: Group A, patients receiving NCA 600mg
once a day for a week and subsequently a culture-guided one-week regimen including a PPI
plus two antibiotics; group B, patients receiving solely a culture-guided one-week
antibiotic treatment including a PPI plus two antibiotics. Sensitive antibiotics will be
always chosen on the basis of the more favorable minimum inhibiting concentration value.
Patients will take a control C13 urea breath test two months after the end of therapy.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Institute of Internal Medicine - Catholic University, Rome 00168, Italy; Recruiting
Giovanni Cammarota, MD, Phone: 0039-06-30155948, Email: gcammarota@rm.unicatt.it
Giovanni Cammarota, MD, Principal Investigator
Additional Information
Starting date: April 2009
Ending date: September 2009
Last updated: September 25, 2009
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