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Helicobacter Infections clinical trials

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NCT ID: NCT01252108 Withdrawn - Clinical trials for Helicobacter Pylori Infection

Evaluation of SQ109 Plus PPI in Urea Breath Test-Positive Volunteers

Start date: March 2012
Phase: Phase 2
Study type: Interventional

Helicobacter pylori infection of the gastric epithelium is the most common bacterial infection worldwide. Its global prevalence is estimated at 50%, though the burden falls disproportionately on the developing world, where the prevalence in some areas is 80%. H. pylori infection is generally acquired during childhood, and without specific antibiotic treatment can persist for life. The infection is generally clinically asymptomatic during childhood, and even in adulthood 80-90% of infected individuals will remain asymptomatic (although they may transmit the bacteria). SQ109 is a new, small molecule antibiotic with characteristics that make it particularly attractive to evaluate against H. pylori. In brief, SQ109 is orally bioavailable, acid-stable, has in vitro activity against H. pylori and achieves high intracellular concentration (which may be important to effect bacterial eradication). Based on the antimicrobial activity and clinical safety, SQ109 will be evaluated in this clinical trial to assess safety and antimicrobial activity in adults infected with H. pylori. Data from this study will help determine whether larger safety and efficacy studies in individuals with H. pylori-associated duodenal ulcer disease are warranted.

NCT ID: NCT01234389 Completed - H. Pylori Infection Clinical Trials

Immediate Detection of Helicobacter Infection With a New Electrochemical System.

Start date: October 2009
Phase: N/A
Study type: Interventional

Helicobacter pylori-infection (H. pylori) affects about fifty percent of the general population and is associated with peptic ulcer disease, non-cardia gastric adenocarcinoma and gastric lymphoma. Currently, diagnostic methods include breath tests, serology, stool antigen tests, histology or the Helicobacter urease test (HUT). The aim of our study is to access the clinical reliability of a new, electrochemical device for rapid H. pylori detection.

NCT ID: NCT01219764 Completed - Clinical trials for Helicobacter Infections

A Trial of Standard vs Half Dose Rabeprazole, Clarithromycin, Metronidazole and Amoxicillin in the Treatment of Helicobacter Pylori Infection

Start date: October 2010
Phase: Phase 4
Study type: Interventional

The proposed study will test the hypothesis that H. pylori can be eradicated successfully (>85%) using half-or full-dose "concomitant" non-bismuth quadruple therapy regimen: rabeprazole, amoxicillin, clarithromycin and metronidazole twice daily for 7 days in patients with peptic ulcers and H. pylori related gastritis. Two hundred patients from the outpatient department and the endoscopy unit at AUBMC will be enrolled in this open-label trial. Patients with positive CLO tests or urea breath tests, documenting H.pylori infection, will be randomized into one of two groups: Full dose or half dose the concomitant regimen, with 100 patients in each group. Compliance and side effects will be assessed, and a urea breath test will be done for all patients after 4 weeks of therapy completion to evaluate eradication rates. Success of therapy will be evaluated according to intent-to treat and per-protocol analyses.

NCT ID: NCT01168063 Completed - Clinical trials for Helicobacter Pylori Infection

Molecular Detection of Antibiotic Resistance and H Pylori Eradication

HELICOSTIC
Start date: February 2010
Phase: N/A
Study type: Interventional

H pylori eradication failure with recommended triple therapy is mainly related to antibiotic resistance. However,IN VITRO culture of H pylori is uneasy and is not performed in routine practice. A molecular test of antibiotic resistance easy to perform is now available. The aim of the study was to compare eradication rates obtained with the standard treatment and with a treatment guided by the results of the molecular detection of antibiotic resistance.

NCT ID: NCT01163435 Completed - Clinical trials for Helicobacter Infection

Efficacy of High Dose Dual Therapy, Sequential Therapy and Triple Therapy in H. Pylori Eradication

Start date: August 2010
Phase: Phase 4
Study type: Interventional

Up to now, to our knowledge, there is few randomized, large scale study prospectively and simultaneously comparing the efficacy, adverse effects and patient adherence of these current recommended 1st-line or 2nd-line regimens for H. pylori eradication in and out of our country. The aims of this study are: 1. to compare the efficacy of high dose dual therapy, sequential therapy and clarithromycin-based triple therapy as 1st-line regimen in H. pylori eradication; 2. to compare the efficacy of high dose dual therapy, sequential therapy and levofloxacin-based triple therapy as rescue regimen in H. pylori eradication; 3. to compare the patient adherence and adverse effects of these treatment regimens; 4. to investigate factors that may influence H. pylori eradication by these treatment regimens; 5. to investigate and analyze the prevalence and trend of antibiotic resistance.

NCT ID: NCT01133951 Active, not recruiting - Stomach Neoplasms Clinical Trials

Helicobacter Pylori Eradication to Prevent Gastric Cancer

Start date: June 2010
Phase: N/A
Study type: Interventional

Gastric cancer is the fourth most common type of cancer and the second leading cause of cancer-related death in the world. In China, more than 390,000 new patients are diagnosed with gastric cancer and more than 300,000 patients are killed by the terrible disease annually. Although gastric cancer has a multifactorial etiology, infection with H. pylori is highly associated with gastric carcinogenesis. Therefore, eradication of H. pylori infection appears to reduce the risk of gastric cancer. However, several recent controlled interventional trials by H. pylori eradication to prevent gastric cancer have yielded disappointing results. The exact effect of H.pylori eradication on prevention of gastric cancer is unclear up to now. To clarify this problem, the investigators conducted a prospective, randomized, double-blind, placebo-controlled, population-based study to determine whether H pylori eradication would reduce the incidence of gastric cancer in a high-risk population in China.

NCT ID: NCT01131026 Completed - Clinical trials for Helicobacter Pylori Infection

Efficacy and Safety Evaluation of Levofloxacin Triple Therapy for Helicobacter Pylori Eradication

Start date: June 2010
Phase: Phase 3
Study type: Interventional

Today, although the triple treatment with clarithromycin accepted as the primary treatment for Helicobacter pylori infection eradication is well tolerated, the eradication has been decreased to 65 %. However, the eradication resulting from TRIOL treatment with levofloxacin is expected to be 75 % or higher. If the target results can be reached, it will be concluded that TRIOL treatment with levofloxacin will be an alternative to the triple treatment with clarithromycin as the primary treatment.

NCT ID: NCT01115296 Recruiting - Clinical trials for Helicobacter Pylori Infection

Control of Helicobacter Pylori Infection by Probiotics

Start date: January 2010
Phase: N/A
Study type: Interventional

Helicobacter pylori colonises an estimated 50% of the world´s population (Taylor & Blaser, 1991; Go, 2002). Despite clear clinical guidelines on the treatment of this infection (Malfertheiner et al. 2007) there is a drive to find alternative ways to control this infection in a wider perspective without the complications of induction of antibiotic resistance in the pathogen. L. reuteri has been widely studied in clinical trials and has been shown to have probiotic, health-promoting effects in both adults and children (Connolly 2004; Casas & Dobrogosz, 2000). L. reuteri has been shown in numerous studies to be safe for human consumption and it has been shown to colonise the human gastrointestinal tract (Wolf et al., 1995, Valeur et al., 2004). Studies using supplementation with L. reuteri in both symptomatic and non-symptomatic H. pylori-infected subjects show a clear reduction of infection load after 4 weeks of use and this was concomitant with a reduction in symptoms associated with the infection (Imase et al. 2007; Francavilla et al. 2007, unpublished data). Further, dietary supplementation with L. reuteri during and after the period of H. pylori eradication therapy has also been shown to reduce the side effects of this therapy without affecting the degree of eradication (Lionetti et al., 2007). It is also feasible, through the inhibitory action of L. reuteri on H. pylori, that pre-exposure to L. reuteri may weaken H. pylori and make it more susceptible to antibiotic attack during eradication. However, an earlier pilot study was not been able to demonstrate a reduction in gastric inflammation caused by H. pylori. This pilot study was performed with L. reuteri ATCC 55730 that has since been found to lack anti-inflammatory activity in in vitro screens. Recent selection of natural, human L. reuteri strains has identified a specific strain with strong anti-inflammatory properties in vitro (Lin et al, 2007 and submitted 2007). A combination of this strain, together with the earlier proven L. reuteri strain, is expected to lead to both a reduction of H. pylori load as well as a reduction in the gastric inflammation related to the pathogen.

NCT ID: NCT01109381 Terminated - Clinical trials for Helicobacter Pylori Infection

Safety and Efficacy Study of a Non-antibiotic Treatment for the Eradication of Helicobacter Pylori

Start date: May 2010
Phase: Phase 1/Phase 2
Study type: Interventional

At present, triple therapy is recommended by various guidelines for the treatment of Helicobacter pylori (H.pylori) infection. Recent studies have shown increasing resistance of H.pylori to commonly used antibiotics used in triple therapy. This study explores a non-antibiotic treatment regime for H.pylori that uses lauric acid as the primary anti-microbial agent. The study hypothesis is that Lauric acid works synergistically with omeprazole following administration of a mucolytic agent to kill H.pylori topically in the stomach.

NCT ID: NCT01085786 Completed - Clinical trials for Helicobacter Pylori Infection

Sequential and Hybrid Therapies for H Pylori Infection

Start date: August 2008
Phase: Phase 4
Study type: Interventional

Primary: To evaluate efficacy of 14 day 2-phase sequential therapy given in two forms. One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days. The alternate will be similar with the exception that the amoxicillin will be continued throughout the 14 days. The secondary endpoint is to evaluate the effectiveness of therapy in relation to antibiotic resistance.