- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00985608
Efficacy of Acetilcysteine in 'Rescue' Therapy for Helicobacter Pylori Infection. Pilot 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Rome, Italy, 00168
- Recruiting
- Institute of Internal Medicine - Catholic University
-
Contact:
- Giovanni Cammarota, MD
- Phone Number: 0039-06-30155948
- Email: gcammarota@rm.unicatt.it
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Principal Investigator:
- Giovanni Cammarota, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group B: antibiotic treatment (control)
patients receiving solely a culture-guided one-week antibiotic treatment including a PPI plus two antibiotics
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patients receiving solely a culture-guided one-week antibiotic treatment including a PPI plus two antibiotics
|
Active Comparator: Group A: NCA 600mg +antibiotics
NCA 600mg once a day for a week and subsequently a culture-guided one-week regimen including a PPI plus two antibiotics
|
NCA 600mg once a day for a week and subsequently a culture-guided one-week regimen including a PPI plus two antibiotics
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Giovanni Cammarota, MD, Catholic University, Institute of Internal Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 253/09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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