Helicobacter Pylori InfectionPhase 2NCT00985608
Efficacy of Acetilcysteine in 'Rescue' Therapy for Helicobacter Pylori Infection. Pilot Study
A Phase 2 study testing Group A: NCA 600 mg+antibiotics in people with Helicobacter Pylori Infection, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Group A: NCA 600 mg+antibiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2009to Sep 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Verified allergies to the acetylcysteine or to the antibiotics to cure Helicobacter pylori
- Pregnancy, nursing
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Institute of Internal Medicine - Catholic University
Rome, 00168
Giovanni Cammarota, MD, 0039-06-30155948, gcammarota@rm.unicatt.it
Giovanni Cammarota, MD
About 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.
Read the 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, in the first phase of the study, the effect of NAC on biofilm formation and on its demolition will be tested in vitro by adding NAC in cultured H pylori isolates from a limited number of patients (n10) with an history of at least 4 failed eradicating attempts. Two biopsy samples of gastric mucosa will be obtained during endoscopy for microbiological purpose. Specimens will be used for H pylori culture. In specimens from 5 patients, H pylori will be cultured together with NAC 2 mg, while in the other 5 cases, H pylori culture will be carried out without NAC. In these latter, after the biofilm formation, H pylori isolates will be faced with different doses of NAC (2 mg, 10 mg, and 20 mg) to observe the behavior of biofilm. In the second phase of the study, 40 patients, after at least four unsuccessful H pylori eradication attempts, will be consecutively recruited. During endoscopy, in each patient, at least 4 mucosal biopsies will be obtained from the gastric body. Two of these biopsies will be used for biofilm study at the scanning electron microscopy (SEM). The remaining biopsies will be used for H pylori culture. From culture, the in vitro antibiotic susceptibility testing together with genetic analysis of H pylori isolates will be performed. On the basis of antibiotic susceptibility testing alone, patients will then randomly assigned to receiving two different eradication schedules: Group A, patients receiving NCA 600 mg once a day for a week and subsequently a culture-guided one-week regimen including a PPI plus two antibiotics against H pylori; group B (control), 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. all patients will have a diary to record the side effects and symptoms during therapy. Compliance will measured by counting the tablets returned after the 7-day treatment. Patients will take a control C13 urea breath test at least two months after the end of therapy. They will be also invited to repeat endoscopic examination for monitoring biofilm persistence or absence. Finally, results obtained with the two treatment arms will be compared and evaluated also on the light of genetic analyses of H pylori isolates.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Group A: NCA 600 mg+antibiotics, Group B: antibiotic treatment (control)
- Keywords
- H pylori, eradication therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A: NCA 600 mg+antibioticsDrug
NCA 600mg once a day for a week and subsequently a culture-guided one-week regimen including a PPI plus two antibiotics
Group B: antibiotic treatment (control)Drug
patients receiving solely a culture-guided one-week antibiotic treatment including a PPI plus two antibiotics
| Study group | Role | What they receive |
|---|---|---|
| Group B: antibiotic treatment (control) | Active comparator | patients receiving solely a culture-guided one-week antibiotic treatment including a PPI plus two antibiotics Receives: Drug: Group B: antibiotic treatment (control) |
| Group A: NCA 600mg +antibiotics | Active comparator | NCA 600mg once a day for a week and subsequently a culture-guided one-week regimen including a PPI plus two antibiotics Receives: Drug: Group A: NCA 600 mg+antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2009 (estimated)
- Study startApr 2009
- Primary completionJul 2009
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Investigators
- Giovanni Cammarota, MD, Principal investigator, Catholic University, Institute of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985608
- Sponsor's protocol ID
- 253/09
- Status last verified
- Sep 2009
- First submitted
- 25 Sep 2009
- Last updated
- 26 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Acetilcysteine in 'Rescue' Therapy for Helicobacter Pylori Infection. Pilot Study
- ClinicalTrials.gov ID
- NCT00985608
- Acronym / sponsor ID
- 253/09
- Conditions
- Helicobacter Pylori Infection
- Keywords
- H pylori, eradication therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Sep 2009 (estimated)
- First posted
- 28 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, in the first phase of the study, the effect of NAC on biofilm formation and on its demolition will be tested in vitro by adding NAC in cultured H pylori isolates from a limited number of patients (n10) with an history of at least 4 failed eradicating attempts. Two biopsy samples of gastric mucosa will be obtained during endoscopy for microbiological purpose. Specimens will be used for H pylori culture. In specimens from 5 patients, H pylori will be cultured together with NAC 2 mg, while in the other 5 cases, H pylori culture will be carried out without NAC. In these latter, after the biofilm formation, H pylori isolates will be faced with different doses of NAC (2 mg, 10 mg, and 20 mg) to observe the behavior of biofilm. In the second phase of the study, 40 patients, after at least four unsuccessful H pylori eradication attempts, will be consecutively recruited. During endoscopy, in each patient, at least 4 mucosal biopsies will be obtained from the gastric body. Two of these biopsies will be used for biofilm study at the scanning electron microscopy (SEM). The remaining biopsies will be used for H pylori culture. From culture, the in vitro antibiotic susceptibility testing together with genetic analysis of H pylori isolates will be performed. On the basis of antibiotic susceptibility testing alone, patients will then randomly assigned to receiving two different eradication schedules: Group A, patients receiving NCA 600 mg once a day for a week and subsequently a culture-guided one-week regimen including a PPI plus two antibiotics against H pylori; group B (control), 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. all patients will have a diary to record the side effects and symptoms during therapy. Compliance will measured by counting the tablets returned after the 7-day treatment. Patients will take a control C13 urea breath test at least two months after the end of therapy. They will be also invited to repeat endoscopic examination for monitoring biofilm persistence or absence. Finally, results obtained with the two treatment arms will be compared and evaluated also on the light of genetic analyses of H pylori isolates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group B: antibiotic treatment (control) | Active comparator | Drug: 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 +antibiotics | Active comparator | 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Verified allergies to the acetylcysteine or to the antibiotics to cure Helicobacter pylori
- Pregnancy, nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 A: NCA 600mg +antibiotics |
| Group B: antibiotic treatment (control)patients receiving solely a culture-guided one-week antibiotic treatment including a PPI plus two antibiotics | Drug | Group B: antibiotic treatment (control) |
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
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Institute of Internal Medicine - Catholic University
Rome, Italy
Giovanni Cammarota, MD principal investigator
Catholic University, Institute of Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Group A: NCA 600 mg+antibiotics in people with Helicobacter Pylori Infection, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2010.