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Helicobacter Pylori Infection clinical trials

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NCT ID: NCT01265069 Recruiting - Clinical trials for Helicobacter Pylori Infection

Efficacy of 10-day Concomitant Regimen Versus High Dose Dual Therapy in Anti-Helicobacter Pylori Rescue Therapy

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

Currently, a 10-day concomitant therapy has been reported to be equally effective and safe to the 10-day sequential therapy for 1st-line anti-Helicobacter pylori(H. pylori) therapy. To our knowledge, there has been no report concerning the efficacy of this regimen used as a rescue therapy. The aims of this study are: 1. to compare the efficacy of high dose dual therapy and concomitant therapy as rescue regimen in H. pylori eradication; 2. to compare the patient adherence and adverse effects of these treatment regimens; 3. to investigate factors that may influence H. pylori eradication by these treatment regimens.

NCT ID: NCT01252108 Withdrawn - Clinical trials for Helicobacter Pylori Infection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

NCT ID: NCT01071759 Recruiting - Pregnancy Clinical Trials

Effects of Dietary Heme/Non-heme Iron and Helicobacter Pylori (Hp) Infection on Maternal Iron-deficiency Anemia and Fetal Growth Outcomes

Start date: February 2009
Phase: N/A
Study type: Observational

Iron deficiency is considered one of the main nutritional deficiency disorders despite the apparent availability of a high-quality diet even in developed countries, and Iron deficiency anemia (IDA) is the most common form of anemia in the world. IDA during pregnancy has been associated with adverse health consequences for both the mother and her developing fetus. Helicobacter pylori (Hp) may be the most common bacterial infection worldwide, infecting almost half of people in developed countries and 80% of people in developing countries. The available data on the prevalence of Hp infection in Taiwan population was 54.4%. We all know that infection with Hp is strongly associated with peptic ulcer and gastric cancer, but recent evidence suggests that Hp is associated with iron deficiency and anemia, although the mechanisms remain unclear. Till now, only few previous studies specifically have addressed a potential role of Hp infection on anemia or iron deficiency during pregnancy. Our previous Research showed, between the Hp infection (+) and Hp infection (-) gravidas, the associations between the Hp infection and iron deficiency were stronger, although not statistically significant. This might be due to that we needed more cases and evidences to prove the relationship between maternal Hp infection and serum iron, ferritin and hemoglobin levels, or we should further consider the interactions of the particular customs or diet preference of the Taiwanese gravidas. This longitudinal study will recruit 140 women from the antenatal care clinics of E-Da Hospital to examine the association between Hp infection and maternal IDA. The standardized interviews of mothers (anthropometric data, socioeconomic status, medical history, obstetric history, alcohol consumption during pregnancy, and history and duration of iron supplementation during pregnancy) will be conducted, Hp infection status will be determined by the urea breath test and IgG enzyme immunoassay, and the measurement of hemoglobin, iron, and ferritin levels will be obtained 5 times at various antepartum and postpartum points of time during pregnancy (routine prenatal visits of 1st, 2nd, and 3rd trimester, puerperium and 2 weeks after delivery). We hope that we could investigate the possible role of Hp infection in iron deficiency and iron-deficiency anemia during pregnancy in Taiwan, and that early detection and treatment of anemia may reduce the risk of blood transfusion and perinatal and maternal mortality.

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: 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