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Helicobacter Infections clinical trials

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NCT ID: NCT01061437 Completed - Clinical trials for Helicobacter Pylori Infection

S0701, Trial of Three Antibiotic Regimens to Eradicate Helicobacter Pylori (H. Pylori)

Start date: June 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effectiveness of three different antibiotic regimens against Helicobacter pylori (H. pylori).

NCT ID: NCT01042184 Completed - H. Pylori Infection Clinical Trials

Efficacy of 10-day and 14-day Sequential Therapy Versus Triple Therapy on the Eradication of Helicobacter Pylori

Start date: December 2009
Phase: Phase 4
Study type: Interventional

Background: Helicobacter pylori infection has been shown to be associated with the development of gastric cancer and peptic ulcer diseases. Eradication of H. pylori infection could reduce the occurence or recurrence of these diseases. However, the eradication rate of clarithromycin-based triple therapy has been declining in recent years, probably related to the increasing resistant rate to clarithromycin. It was estimated that 15-20% of patients would fail from first line standard eradication therapy and need second line rescue therapy. About 15-30% of patient would fail from second line therapy and need to be rescued with third line therapy. In recent years, the concept of sequential therapy has been advocated in the treatment of H. pylori infection. The regimen includes a PPI plus amoxicillin for five days, followed by a PPI plus clarithromycin and tinidazole for another five days. The eradication rate in the first line treatment of sequential therapy had been reported to be as high as 90%. More importantly, it has been demonstrated that the eradication rate among patients with clarithromycin-resistant strains could be as high as 89%. However, tinidazole is not available in many countries. Whether metronidazole would be an effective alternative to tinidazole in the sequential therapy remains unknown. Besides, whether extending the duration of sequential therapy from 10-day to 14-day would result in higher eradication rate also deserves further investigation. Furthermore, data on the efficacy of rescue regimens for patients who failed from first line sequential therapy are also lacking. The impact of clarithromycin, metronidazole resistance and CYP2C19 polymorphism on the sequential therapy containing metronidazole (rather than tinidazole) also has not been reported. Aims: Therefore, we aim to assess 1. whether the substitution of metronidazole for tinidazole in the sequential therapy is also more effective than clarithromycin-based triple therapy 2. whether extending the duration of sequential therapy from 10-day to 14-day would achieve higher eradication rate 3. whether levofloxacin-based sequential therapy for 14-days is effective as second line rescue regimen for those who failed from first line sequential therapy 4. the impact of antibiotic resistance and CYP2C19 polymorphism on the eradication rate of sequential therapy

NCT ID: NCT01032655 Completed - Clinical trials for Helicobacter Pylori Infection

The Efficacy of Susceptibility Test -Driven Sequential Therapy as the Third Line Therapy for Refractory Helicobacter Pylori Infection

Start date: April 2009
Phase: Phase 4
Study type: Interventional

Background: Helicobacter pylori infection has been shown to be associated with the development of gastric cancer and peptic ulcer diseases. Eradication of H. pylori infection could reduce the occurence or recurrence of these diseases. However, it was estimated that 15-20% of patients would fail from first line standard eradication therapy and need second line rescue therapy. About 15-30% of patient would fail from second line therapy and need to be rescued with third line therapy. The commonly used salvage regimens include (1) Bismuth based quadruple therapy (combined with ranitidine or PPI plus two antibiotics) (2) Levofloxacin or moxifloxacin or rifabutin based triple therapy. However, Bismuth is not available in many countries and the administration method is complex. Its usage is limited by the high pill number and low compliance rate. In recent years, the concept of sequential therapy has been advocated in the treatment of H. pylori infection. The regimen includes a PPI plus amoxicillin for five days, followed by a PPI plus clarithromycin and metronidazole for another five days. The eradication rate in the first line treatment of sequential therapy had been reported to be as high as 90%. More importantly, it has been demonstrated that the eradication rate among patients with clarithromycin-resistant strains could be as high as 89%. According to the Maastricht III consensus meeting, it was recommended that susceptibility test should be done for patients who failed two treatments. Therefore, we aimed to assess the efficacy of susceptibility test driven sequential therapy as the third line therapy for those who fail from two standard eradication therapies. Methods: This will be a multi-center, open labeled pilot study 1. Patients: - Open labeled, non-comparative pilot study 2. Testing for H. pylori infection: - Before salvage treatment: either (1) any two positive of CLO test, histology, and culture or (2) a positive C13-UBT will be considered as failure of previous eradication treatment EGD with gastric biopsy will be done for H. pylori culture and susceptibility test - After salvage treatment: C13-UBT will be used to assess the existence of H. pylori after 2nd or 3rd line salvage therapy 3. Treatment regimens and assignment: - D1-7: Nexium (40 mg, bid), Amolin (1 gm, bid) - D8-14: Nexium (40 mg, bid), Flagyl (500 mg, bid) plus either one of the following according to antibiotic susceptibility test (1) Klaricid, 500 mg, bid or (2) Cravit, 250 mg, bid or (3) Tetracycline, 500 mg, bid 4. Outcome Measurement: - Primary End Point: Eradication rate will be evaluated according to Intent-to-treat (ITT) and per-protocol (PP) analyses - Secondary End Point: the eradication rate according to antibiotic susceptibility before salvage therapy

NCT ID: NCT00885417 Completed - H. Pylori Infection Clinical Trials

The Efficacy of Sequential Therapy as Second Line Therapy for Refractory Helicobacter Pylori Infection - A Pilot Study

Start date: April 2009
Phase: Phase 4
Study type: Interventional

Helicobacter pylori infection has been shown to be associated with the development of gastric cancer and peptic ulcer diseases. Eradication of H. pylori infection could reduce the occurence or recurrence of these diseases. However, it was estimated that 15-20% of patients would fail from first line standard eradication therapy and need second line rescue therapy. About 15-30% of patient would fail from second line therapy and need to be rescued with third line therapy. The commonly used salvage regimens include: 1. Bismuth based quadruple therapy (combined with ranitidine or proton-pump inhibitor (PPI) plus two antibiotics) 2. Levofloxacin or moxifloxacin or rifabutin based triple therapy. However, Bismuth is not available in many countries and the administration method is complex. Its usage is limited by the high pill number and low compliance rate. In recent years, the concept of sequential therapy has been advocated in the treatment of H. pylori infection. The regimen includes a PPI plus amoxicillin for five days, followed by a PPI plus clarithromycin and metronidazole for another five days. The eradication rate in the first line treatment of sequential therapy had been reported to be as high as 90%. More importantly, it has been demonstrated that the eradication rate among patients with clarithromycin-resistant strains could be as high as 89%. Aims: Therefore, the investigators aim to assess the efficacy of levofloxacin-based sequential therapy as second line therapy for those who fail from one standard eradication therapy.

NCT ID: NCT00867867 Completed - Clinical trials for Healthy Participants

Ferrous Fumarate and Ferric Pyrophosphate as Food Fortificants in Developing Countries

Start date: October 2003
Phase: Phase 1
Study type: Interventional

Iron fortification of foods is usually considered the most cost-effective approach to prevent iron deficiency. However, iron is the most difficult mineral to add to foods. When added as water-soluble, highly bioavailable compounds such as ferrous sulfate, the soluble iron rapidly catalyzes fat oxidation resulting in rancid products. In addition, water-soluble iron compounds can cause unacceptable color reactions during storage and food preparation. Thus, food manufacturers are often obliged to use water-insoluble iron compounds to fortify foods and fortification compounds such as elemental Fe powder and ferric pyrophosphate are widely used to fortify cereal flours and infant cereals. However, these compounds never dissolve completely in the gastric juice and are usually far less well absorbed than ferrous sulfate (Hurrell 1997). Ferrous fumarate on the other hand, although almost insoluble in water, readily dissolves in the gastric juice and has been shown to have an equivalent absorption to ferrous sulfate in healthy, Western adults (Hurrell et al. 1989, 2000). Because it is non-water soluble, it causes relatively few sensory problems in the fortified foods and is therefore an interesting food fortificant. Iron absorption from ferrous fumarate has been demonstrated to be significantly higher than from ferric pyrophosphate in European infants (Davidsson et al. 2000) and this compound is currently used to fortify blended cereal flours for food aid programs and commercial infant cereals in Europe. However, based on our recent study in Bangladeshi children, there is now concern that due to lower gastric acid output, young children in developing countries may not be able to absorb ferrous fumarate as well as Western adults (Davidsson et al. 2001a, Sarker et al. 2001, 2003). Clearly, there is a need to evaluate the efficacy of water insoluble iron compounds to prevent the development of iron deficiency/iron deficiency anemia in infants and young children living in developing countries. The aim of this study is to evaluate the efficacy of ferrous fumarate and ferric pyrophosphate, as compared to ferrous sulfate, as food fortificants in preventing development of anemia/IDA in Bangladeshi infants and young children (part I). A potential cause of low gastric acid secretion in Bangladesh and many developing countries is Helicobacter pylori infection. Although H. pylori-infection appeared to have no influence on absorption of ferrous fumarate in children, the impact of chronic H. pylori infection in adults could be expected to be more pronounced due to long time effects on the gastric mucosa, resulting in reduced gastric acid output. The other aim of the study is therefore, to assess of iron absorption and gastric acid output in adult women of child-bearing age with H. pylori infection (part II). Two hundred and forty non-anemic Children (Hb>105 g/L) will be randomized to three study groups; ferrous fumarate, ferric pyrophosphate or ferrous sulfate (n=80 per group) in wheat flour- and cow milk-based infant formula and will be fed for 9 months. Hemoglobin, serum ferritin, and transferin receptor will be analyzed at baseline and after 4.5 and 9 months of intervention. Prevalence of anemia and iron deficiency during and after the intervention among the three groups will be compared (part I). We furthermore propose a complementary study to determine the relative absorption of ferrous fumarate (relative to ferrous sulfate) in H. pylori infected and non-infected adult Bangladeshi women (15 each) of 20-40 year of age with IDA using stable isotope technique based on the incorporation of iron stable isotopes into erythrocytes 14 days after administration. Assessment of gastric acid output will also be performed. Iron stature and absorption, and assessment of gastric acid output will be compared before and after therapy in H. pylori infected women (part II). The results of this study are expected to have implications in the prevention and treatment of iron deficiency anemia in developing countries

NCT ID: NCT00854451 Completed - Clinical trials for Helicobacter Pylori Infection

Relation of Metabolic Rate of Omeprazole and Eradication of Helicobacter Pylori Infection

Start date: August 1996
Phase: Phase 4
Study type: Interventional

The aims of this study are (1) to evaluate the prevalence rate of PM of CYP2C19 in our country; (2) to evaluate the efficacy of dual therapy with different dose of omeprazole and amoxicillin; (3) to judge the relationship of genotype of CYP2C19 and the eradication rate of dual therapy in the peptic ulcer patients; (4) to try to find out a predictor of success of dual therapy and an optimal dose of dual therapy as first-line and rescue anti-Helicobacter pylori regimen.

NCT ID: NCT00841854 Completed - Clinical trials for Helicobacter Infection

Comparison of 7-day and 14-day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication

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

At present, triple therapy are recommended by various guidelines for the treatment of Helicobacter pylori (H. pylori) infection. Recent studies have shown worldwide high treatment failure rates with one week first line clarithromycin based triple therapy necessitating salvage strategy to eradicate H. pylori in primary treatment failure. However, the exact duration of bismuth based second line treatment is not determined. Therefore, the investigators performed this study to evaluate the eradication rate of 1 or 2-week quadruple regimen as a second-line therapy.

NCT ID: NCT00841490 Completed - Clinical trials for Helicobacter Pylori Infection

Oral H. Pylori Prevalence in Intellectually & Developmentally Disabled Adults

Start date: September 2008
Phase: N/A
Study type: Observational

The purpose of this study is to determine if the bacteria that cause gastric infections can be found in the mouths of intellectually and developmentally disabled persons. If the bacteria that causes gastric infections is found in the mouth it may be swallowed and contribute to gastric infections.

NCT ID: NCT00816140 Completed - Clinical trials for Helicobacter Infections

Levofloxacin Versus Clarithromycin Triple Therapy in First-Line Treatment for Helicobacter Pylori Eradication

Start date: June 2007
Phase: Phase 4
Study type: Interventional

Clarithromycin-based triple therapy containing a proton-pump inhibitor (PPI) twice daily, amoxicillin 1g twice daily, and clarithromycin 500 mg twice daily for 7 days is one of the standard firs-line therapy for Helicobacter pylori eradication. However, because of unsatisfactory eradication rate (80-85%), the Maastricht III guideline recommended extending the treatment duration to increase the eradication rate. Recently, levofloxacin (500 mg qd)-based triple therapy has been shown to achieve an eradication rate of 90% for both the first- and second-line treatment for H. pylori eradication. Several studies have demonstrated that high dose (750mg) and short-course (5 days) levofloxacin is as effective and well tolerated as traditional dose (500mg) and course (10 days) for treatment of mild-to-severe community acquired pneumonia. The high dose and short-course therapy has the potential to increase patient compliance and reduce bacterial resistance to fluoroquinolones. However, whether increasing the dosage of levofloxacin from 500mg to 750 mg qd can augment the efficacy of triple therapy in eradication of H. pylori and shorten the duration of therapy remains unknown. Although levofloxacin-based regimen was presumed to be more effective, previous reports pointed the concern that resistance to fluoroquinolone and other antibiotics which susceptible to the pumping efflux of bacteriae would increase among the gut flora.

NCT ID: NCT00772837 Completed - Clinical trials for Helicobacter Pylori Infection

Effect of Eradication of Helicobacter Pylori on the Dyspeptic Symptoms

EEHPDS
Start date: August 2006
Phase: N/A
Study type: Interventional

Helicobacter pylori eradication and its impact on symptoms in patients with non-ulcer dyspepsia remain controversial . Many studies have examined the effect of H. pylori eradication on dyspeptic symptoms, but the results have been conflicting and inconclusive, with as many studies yielding positive as negative results. Some studies have shown a significant (although weak) symptomatic improvement after H. pylori eradication, and while other yielding negative results. A recent Cochrane review has comprehensively demonstrated that H.pylori eradication therapy has a small but statistically significant effect in H.pylori positive non-ulcer dyspepsia. An economic model suggests this modest benefit may still be cost effective . However it is difficult to reconcile these results in areas with very high prevalence of H. pylori infection such as Pakistan since no such studies have been conducted in developing countries. The investigators hypothesize that eradication of Helicobacter pylori (H. pylori) leads to a sustained improvement in symptoms of patients diagnosed with H. pylori associated functional (non-ulcer) dyspepsia.