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

NCT00985608 | Unknown Phase 2

• 1 other identifier: 253/09
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Helicobacter Pylori Infection

Keywords

H pylori; eradication therapy

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Study Arms (2)

Group B: antibiotic treatment (control)

ACTIVE COMPARATOR

patients receiving solely a culture-guided one-week antibiotic treatment including a PPI plus two antibiotics

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

Drug: Group A: NCA 600 mg+antibiotics

Interventions

Group A: NCA 600 mg+antibiotics DRUG

NCA 600mg once a day for a week and subsequently a culture-guided one-week regimen including a PPI plus two antibiotics

Group A: NCA 600mg +antibiotics

Group B: antibiotic treatment (control) DRUG

patients receiving solely a culture-guided one-week antibiotic treatment including a PPI plus two antibiotics

Group B: antibiotic treatment (control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Verified allergies to the acetylcysteine or to the antibiotics to cure Helicobacter pylori
• Pregnancy, nursing

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Institute of Internal Medicine - Catholic University

Rome, 00168, Italy

RECRUITING

MeSH Terms

Interventions

Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Giovanni Cammarota, MD

  Catholic University, Institute of Internal Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 25, 2009
• First Posted: September 28, 2009
• Study Start: April 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: September 1, 2009
• Last Updated: January 26, 2010

Record last verified: 2009-09

Locations

IT (1)