Immunization against Natural Helicobacter pylori Infection in Nonhuman Primates

ABSTRACT Helicobacter pylori infection is widespread in some breeding groups of a rhesus monkey colony (71% H. pyloripositive by 1 year), and the rate of seroconversion is also high. As a result, these groups can be used to test the safety and efficacy of an anti-H. pylori vaccine. Nine-month-old female animals were randomized to receive either 8 mg of recombinant urease (rUre) plus 25 μg of Escherichia coli heat-labile enterotoxin (LT) (n = 26) or placebo plus LT (n = 29), given four times at 1-week intervals followed by a booster 1 month later. Ten months after the start of the immunization, the animals were subjected to endoscopy and biopsy samples were obtained. H. pylori negativity was defined as no H. pylori growth by culture and no H. pylori observed at histology. By this criterion, 2 (7%) of 29 animals receiving placebo and 8 (31%) of 26 immunized animals were H. pylori negative (P < 0.035). In addition, antral gastritis score was significantly less in H. pylori-negative immunized monkeys than in H. pylori-positive animals, whether they were given rUre plus LT or placebo plus LT (P < 0.02 orP < 0.01, respectively). Interestingly, antral gastritis was also significantly less in H. pylori-positive animals given rUre plus LT than in H. pylori-positive animals given placebo plus LT (P < 0.02). However, quantitative cultures did not demonstrate significant differences between the two latter groups. It is concluded that oral administration of rUre vaccine plus LT significantly protects nonhuman primates against H. pylori infection while not causing undesirable side effects.

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Helicobacter pylori eradication using tetracycline and furazolidone versus amoxicillin and azithromycin in lansoprazole based triple therapy: an open randomized clinical trial

Arquivos de Gastroenterologia ◽

10.1590/s0004-28032005000200009 ◽

2005 ◽

Vol 42 (2) ◽

pp. 111-115 ◽

Cited By ~ 9

Author(s):

Laura Cidrão Frota ◽

Maria do Perpétuo Socorro Saldanha da Cunha ◽

Carlos René Lima Luz ◽

Antonio Haroldo de Araujo-Filho ◽

Luciano A. S. Frota ◽

...

Keyword(s):

Helicobacter Pylori ◽

Triple Therapy ◽

Protocol Analysis ◽

Urea Breath Test ◽

Test Results ◽

Suitable Alternative ◽

Helicobacter Pylori Eradication ◽

Helicobacter Pylori Treatment ◽

H Pylori ◽

To Receive

BACKGROUND: Optimal anti-Helicobacter pylori treatment has not yet been established. AIM: To evaluate H. pylori eradication using tetracycline and furazolidone versus amoxicillin and azithromycin in lansoprazole based triple therapy in northeastern of Brazil. PATIENTS AND METHODS: One hundred and four patients with H. pylori infection, as determined by rapid urease testing and histology, were randomly assigned to receive either: lansoprazole (30 mg q.d.), tetracycline (500 mg q.i.d.), and furazolidone (200 mg t.i.d.) for 7 days (LTF; n = 52); or lansoprazole (30 mg b.i.d.) and amoxicillin (1 g b.i.d.) for 1 week, plus azithromycin (500 mg q.d.) for the first 3 days (LAAz; n = 52). H. pylori eradication was assessed 3 months following completion of therapy by means of rapid urease testing, histology and a 14C-urea breath test. RESULTS: H. pylori eradication was achieved in 46 of 52 (88.4%, 95% CI: 77.5%-95.1%) patients in LTF group and in 14 of 52 (26.9%, 95% CI: 16.2%-40,1%) patients in LAAz group. On a per-protocol analysis, eradication rates were 91.8% (95% CI: 81.4%-97.3%) and 28.5% (95% CI: 17.2%-42.3%), respectively in LTF and LAAz groups. CONCLUSION: The LAAz regimen yielded unacceptably low eradication rates. On the other hand, the LTF scheme represents a suitable alternative for H. pylori eradication.

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The efficacy and safety of quadruple therapy without bismuth (concomitant therapy) in the treatment of patients with Helicobacter pylori - associated gastric and duodenal peptic ulcer disease

Terapevticheskii arkhiv ◽

10.26442/00403660.2019.08.000382 ◽

2019 ◽

Vol 91 (8) ◽

pp. 28-33 ◽

Cited By ~ 1

Author(s):

A M Veliev ◽

I V Maev ◽

D N Andreev ◽

D T Dicheva ◽

A V Zaborovskii ◽

...

Keyword(s):

Duodenal Ulcer ◽

Helicobacter Pylori ◽

Side Effects ◽

Triple Therapy ◽

Eradication Therapy ◽

Test System ◽

Efficacy And Safety ◽

Concomitant Therapy ◽

Quadruple Therapy ◽

H Pylori

Aim. Evaluation of the efficacy and safety of quadrupletherapy without bismuth (concomitant therapy) in patients with Helicobacter pylori - associated gastric ulcer and duodenal ulcer in the framework of a comparative research in the population of patients in Russia. Materials and methods. A prospective randomized trial was conducted, which included 210 patients with H. pylori - associated gastric/duodenal ulcer without complications. During the process of randomization, the patients were divided into three equal groups (n=70) depending on the prescribed 10-day scheme of eradication therapy (ET): the first group received the classic triple scheme (Omeprazole 20 mg 2 times a day, Amoxicillin 1000 mg 2 times a day and Clarithromycin 500 mg 2 times a day); the second group received quadruple therapy with bismuth drugs (Omeprazole 20 mg 2 times a day, Tetracycline 500 mg 4 times a day, Metronidazole 500 mg 3 times a day, Bismuth subcitrate potassium 120 mg 4 times a day); the third group received quadruple therapy without bismuth - concomitant therapy (Omeprazole 20 mg 2 times a day, Amoxicillin 1000 mg 2 times a day, Clarithromycin 500 mg 2 times a day and Metronidazole 500 mg 2 times a day). Diagnostics of H. pylori infection during screening and control of eradication was carried out via the fast urease biopsy sample test and urea breath test system. Control of the effectiveness of ET of the microorganism was carried out not earlier than 4 weeks after the end of the treatment. During the course of therapy, the frequency of development of side effects was assessed using a special questionnaire. Results and discussion. The effectiveness of triple therapy was 72.8% (ITT; 95% CI of 62.17-83.54) and 78,4% (PP; 95% CI 68.19-88.72); quadruple therapy with the preparation of bismuth - 80.0% (ITT; 95% CI 70.39-89.6) and 84,8% (PP; 95% CI, 75.96-93.73); quadruple therapy without bismuth - concomitant therapy - 84.2% (ITT; 95% CI 75.54-93.02) and 92.1% (PP; 95% CI 85.43-98.94). Quadruple therapy without bismuth was reliably more effective than the classical triple therapy in the PP selection (p=0.044883). Statistical analysis showed a tendency to poorer effectiveness of ET in patients who had previously used antibiotic therapy (OR 0.4317; 95% CI 0.1776-1.049), and in individuals with a rapid metabolism genotype - CYP2C19*1/*1 (OR 0.12; 95% CI 0.005848-2.4624). The frequency of development of side effects during the use of triple therapy was 18.5% (95% CI of 9.23-27.91), when using quadruple therapy with bismuth - 20.0% (95% CI 10.39-29.6), and with the use of quadruple therapy without bismuth - concomitant therapy - 24.2% (95% CI 13.98-34.58). Conclusion. This prospective randomized study demonstrated the high efficiency of quadruple therapy without bismuth (concomitant therapy) in the framework of eradication of H. pylori infection in Russia.

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EP20 Long term safety and efficacy of denosumab and zoledronate

Rheumatology ◽

10.1093/rheumatology/keaa109.019 ◽

2020 ◽

Vol 59 (Supplement_2) ◽

Author(s):

Ziad Alkutobi ◽

Deena Laila ◽

Mohammad Tariq

Keyword(s):

Side Effects ◽

Neck Of Femur ◽

Dxa Scan ◽

Safety And Efficacy ◽

Oral Bisphosphonate ◽

Retrospective Audit ◽

Number Of Patients ◽

Gastrointestinal Side Effects ◽

To Receive

Abstract Background Denosumab and zoledronate are increasingly prescribed for primary and secondary osteoporosis long-term management. Methods A retrospective audit was conducted at Basildon Hospital during 2012-2019 using the NICE guidelines standards to evaluate the long term safety and efficacy of denosumab and zoledronate. Number of patients was 84, diagnosed with osteoporosis or osteopenia, 34 of them received 10 or more denosumab injections and 50 patients planned to receive 5 zoledronate infusions (9 patients received 5 and 38 patients received 4). Results Forty percent of the patients were at their 8th decade followed by 28.57% and 21.42 % at their 9th and 7th decades respectively. More than 90% were Caucasian females. Primary prevention was in 39.28% and secondary prevention in 60.71%. The commonest sites of fracture were the wrist and vertebrae at 34.37% for each; followed by the neck of femur and humerous at 12.5% for each. Denosumab was the 1st, 2nd, 3rd or 4th line of treatment in 9.52%, 13.09%, 16.66% and 1.19% respectively; whereas zoledronate was the 1st, 2nd or 3rd line of treatment in 13.09%, 40.47% and 5.95% respectively. The commonest reason for choosing denosumab as the first line was chronic kidney disease, whereas the reason for choosing it as the 2nd or 3rd line was inefficacy of bisphosphonate in 69% or gastrointestinal side effects in 14%. Zoledronate was chosen in all cases because of intolerability to oral bisphosphonate or gastrointestinal side effects. Repeat DXA scan was performed after the 5th, 10th denosumab injections and the 3rd zoledronate infusions. After the 5th Denosumab, DXA scan showed improvement or stability in 100% and 85.29% at the spine and hip respectively whilst deterioration was seen in 14.7% at the hip. After the 10th denosumab, the rate of improvement or stability at the spine was reduced to 88.23% and decline was seen in 2.94%. At the hip area, 73.52% continued to show improvement or stability, whilst 17.66 % showed deterioration. After the 3rd zoledronate, 98% and 88% showed improvement or stability at the spine and hip respectively whilst deterioration seen in 2% and 12% at the spine and hip respectively. One patient on zoledronate experienced dental issues after the 4th injection and stopped treatment. There were no jaw osteonecrosis, no new fractures and no significant side effects with either denosumab or zoledronate. Ninety percent of patients who completed 10 denosumab injections were planned to continue for another 5 injections. Conclusion After the period of 3-5 years, denosumab and zoledronate were well tolerated and BMD was either stable or improved at both spinal and hip sites. There were few cases of deterioration mainly at the hip area with both zoledronate and denosumab. Future researches are needed to stratify guidelines on discontinuation of denosumab. Disclosures Z. Alkutobi None. D. Laila None. M. Tariq None. A. Nandagudi None.

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Antibacterial Activity of Geraniol in Combination with Standard Antibiotics against Staphylococcus aureus, Escherichia coli and Helicobacter pylori

Natural Product Communications ◽

10.1177/1934578x1801300701 ◽

2018 ◽

Vol 13 (7) ◽

pp. 1934578X1801300 ◽

Cited By ~ 1

Author(s):

Subrat Kumar Bhattamisra ◽

Chew Hui Kuean ◽

Lee Boon Chieh ◽

Vivian Lee Yean Yan ◽

Chin Koh Lee ◽

...

Keyword(s):

Escherichia Coli ◽

Staphylococcus Aureus ◽

Helicobacter Pylori ◽

Antibacterial Activity ◽

Synergistic Effect ◽

Inhibitory Concentration ◽

Therapeutic Potential ◽

E Coli ◽

Checkerboard Assay ◽

H Pylori

The antibacterial activity of geraniol and its effect in combination with ampicillin, amoxicillin and clarithromycin against Staphylococcus aureus, Escherichia coli and Helicobacter pylori was tested. The minimum inhibitory concentrations (MICs) and combinatory effects of geraniol against the bacteria were assessed by using the modified broth microdilution and checkerboard assay, respectively. The combinatory effect is expressed as fractional inhibitory concentration index (FICI). The MIC of geraniol against S. aureus, E. coli and H. pylori was found to be 11200, 5600, and 7325 μg/mL, respectively. A significant synergistic effect was observed with geraniol and ampicillin against S. aureus with FICI in the range 0.19 to 0.32. Geraniol and ampicillin exhibited a partial synergistic effect against E. coli. A similar effect was observed with geraniol and clarithromycin against S. aureus. A partial synergistic effect was observed with clarithromycin and geraniol against H. pylori with the FICI value in the range 0.86 to 0.89. An additive effect was observed with geraniol and amoxicillin combination against H. pylori. However, the amoxicillin and clarithromycin dose was reduced by thirty-two fold when combined with geraniol against H. pylori. The anti- H. pylori effect of geraniol with clarithromycin and amoxicillin could be of potential interest in the treatment of H. pylori infection and associated ulcers in humans. Further, geraniol, in combination with other antibiotics, has substantial therapeutic potential against S. aureus and E.coli infection.

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Verrucous antral gastritis in relation to Helicobacter pylori infection, nutrition, and gastric atrophy

Gastroenterology Report ◽

10.1093/gastro/goz057 ◽

2019 ◽

Vol 8 (4) ◽

pp. 293-298

Author(s):

Naoko Tsuji ◽

Yasuko Umehara ◽

Mamoru Takenaka ◽

Yasunori Minami ◽

Tomohiro Watanabe ◽

...

Keyword(s):

Helicobacter Pylori ◽

Reflux Esophagitis ◽

English Literature ◽

Indigo Carmine ◽

Gastric Atrophy ◽

Helicobacter Pylori Infection ◽

Antral Gastritis ◽

Numerous Type ◽

History Of ◽

H Pylori

Abstract Background There have been few studies in the English literature regarding verrucous gastritis (VG). The present study investigated the clinical and endoscopic features of verrucous antral gastritis, especially focusing on Helicobacter pylori infection, nutrition, and gastric atrophy. Methods We performed a retrospective study of patients who underwent routine endoscopy with indigo carmine chromoendoscopy and a comparative study was conducted between VG-positive and VG-negative groups. VG was subdivided into classical and numerous types based on the number and distribution of verrucous lesions. Demographic, clinical, and endoscopic data including body mass index (BMI), serum albumin and cholesterol, gastric atrophy, reflux oesophagitis, Barrett’s oesophagus, and H. pylori status were collected. Univariate and multivariable analyses were performed to identify factors associated with VG. Results We analysed the data of 621 patients undergoing routine endoscopy and found that VG (n = 352) was significantly associated with increased BMI (1.12 [1.05–1.18], P < 0.01), reflux esophagitis (1.96 [1.10–3.28], P < 0.01), and H. pylori negativity with or without a history of eradication (9.94 [6.00–16.47] and 6.12 [3.51–10.68], P < 0.001, respectively). Numerous-type (n = 163) VG was associated with both closed- and open-type gastric atrophy (9.9 [4.04–21.37] and 8.10 [3.41–19.24], P < 0.001, respectively). There were no statistical differences between groups regarding age, sex, total cholesterol, albumin, and bile-colored gastric juice. Conclusions Verrucous antral gastritis was related to increased BMI, reflux esophagitis, and H. pylori negativity. Numerous-type verrucous lesions were associated with gastric atrophy. These indicate that VG may be a physiological phenomenon due to high gastric acidity, mechanical overload, and vulnerability of background mucosa.

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Bacterial killing in gastric juice – effect of pH and pepsin on Escherichia coli and Helicobacter pylori

Journal of Medical Microbiology ◽

10.1099/jmm.0.46611-0 ◽

2006 ◽

Vol 55 (9) ◽

pp. 1265-1270 ◽

Cited By ~ 59

Author(s):

H. Zhu ◽

C. A. Hart ◽

D. Sales ◽

N. B. Roberts

Keyword(s):

Escherichia Coli ◽

Helicobacter Pylori ◽

Gastric Juice ◽

Bacterial Killing ◽

E Coli ◽

Test Organisms ◽

H Pylori ◽

Ph Range ◽

K 12 ◽

Rough Mutant

The susceptibility of Escherichia coli and Helicobacter pylori to pH and the effect of pepsin-mediated proteolysis were investigated. This was to establish the relative importance of their bacterial killing properties in gastric juice. Solutions in the pH range 1.5–7.4 with or without pig pepsin A were used, together with seven gastric juice samples obtained from patients undergoing routine gastric collection. Escherichia coli C690 (a capsulate strain), E. coli K-12 (a rough mutant) and Helicobacter pylori E5 were selected as the test organisms. Suspensions of bacteria (1×106 E. coli ml−1 and 1×108 H. pylori ml−1) were pre-incubated with test solutions at 37 °C for up to 2 h, and then cultured to establish the effect on subsequent growth. Survival of bacteria was diminished at pHs of less than 3.5, whereas killing required a pH of less than 2.5. Pre-incubation with pig pepsin at 0.5, 1.0 and 2.0 mg ml−1 at pH 3.5 reduced viable counts by 100 % for E. coli 690 and E. coli K-12 after 100 min incubation. With H. pylori, the viable counts decreased to 50 % of the control after 20 min incubation in 1 mg pepsin ml−1 at pH 2.5, 3.0 and 3.5. The gastric juices showed bactericidal activity at pH 3.5, and the rate of killing was juice dependent, with complete death of E. coli 690 occurring between 5 and 40 min post-incubation. Thus, killing of E. coli and H. pylori occurs optimally at pHs of less than 2.5. At pH 3.5, little effect is observed, whereas addition of pepsin alone or in gastric juice causes a marked increase in bacterial susceptibility, suggesting an important role for proteolysis in the killing of bacteria.

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16S rRNA Mutations That Confer Tetracycline Resistance in Helicobacter pylori Decrease Drug Binding in Escherichia coli Ribosomes

Journal of Bacteriology ◽

10.1128/jb.187.11.3708-3712.2005 ◽

2005 ◽

Vol 187 (11) ◽

pp. 3708-3712 ◽

Cited By ~ 27

Author(s):

Lisa Nonaka ◽

Sean R. Connell ◽

Diane E. Taylor

Keyword(s):

Escherichia Coli ◽

Helicobacter Pylori ◽

16S Rrna ◽

Binding Site ◽

Tetracycline Resistance ◽

Drug Binding ◽

Multicopy Plasmid ◽

Wild Type ◽

E Coli ◽

H Pylori

ABSTRACT Tetracycline resistance in clinical isolates of Helicobacter pylori has been associated with nucleotide substitutions at positions 965 to 967 in the 16S rRNA. We constructed mutants which had different sequences at 965 to 967 in the 16S rRNA gene present on a multicopy plasmid in Escherichia coli strain TA527, in which all seven rrn genes were deleted. The MICs for tetracycline of all mutants having single, double, or triple substitutions at the 965 to 967 region that were previously found in highly resistant H. pylori isolates were higher than that of the mutant exhibiting the wild-type sequence of tetracycline-susceptible H. pylori. The MIC of the mutant with the 965TTC967 triple substitution was 32 times higher than that of the E. coli mutant with the 965AGA967 substitution present in wild-type H. pylori. The ribosomes extracted from the tetracycline-resistant E. coli 965TTC967 variant bound less tetracycline than E. coli with the wild-type H. pylori sequence at this region. The concentration of tetracycline bound to the ribosome was 40% that of the wild type. The results of this study suggest that tetracycline binding to the primary binding site (Tet-1) of the ribosome at positions 965 to 967 is influenced by its sequence patterns, which form the primary binding site for tetracycline.

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Helicobacter Pylori Associated Antral Gastritis in Peptic Ulcer Disease Patients and Normal Healthy Population of Kashmir, India

Diagnostic and Therapeutic Endoscopy ◽

10.1155/dte.4.135 ◽

1998 ◽

Vol 4 (3) ◽

pp. 135-139 ◽

Cited By ~ 2

Author(s):

Gh. Jeelani Romshoo ◽

G. M. Malik ◽

M. Youssuf Bhat ◽

Ab. Rashid rather ◽

Javaid Ahmad Basu ◽

...

Keyword(s):

Helicobacter Pylori ◽

Peptic Ulcer ◽

Gastric Ulcer ◽

Peptic Ulcer Disease ◽

Healthy Volunteers ◽

Chronic Gastritis ◽

Healthy Population ◽

Ulcer Disease ◽

Antral Gastritis ◽

H Pylori

Aim: To study the association of Helicobacter pylori infection with chronic antral gastritis in peptic ulcer disease patients and healthy population of Kashmir.Methods: 50 peptic ulcer patients (duodenal ulcer = 46, gastric ulcer = 2 and combined duodenal and gastric ulcer = 2) and 30 asymptomatic healthy volunteers were included in this study. Peptic ulcer was diagnosed on endoscopic examination. 4–6 punch biopsies were taken from gastric antrum in all the individuals and in case of gastric ulcer an additional biopsy was taken from the edge of the ulcer to exclude its malignant nature. Helicobacter pylori (H. pylori) organism was diagnosed using three different test methods, viz. Histology (using Giemsa Stain), Microbiology (Gram Stain) and Biochemistry (using one minute Endoscopy Room Test). Histological diagnosis of H. pylori was taken as the “gold standard” for the presence of H. pylori organism. Histological diagnosis of gastritis was made using Hematoxylin and Eosin Stain and the gastritis was classified as active chronic gastritis and superficial chronic gastritis.Results: Out of 30 peptic ulcer disease patients with associated antral gastritis, 27 (90%) were positive for H. pylori on histological examination (13 superficial chronic gastritis and 14 active chronic gastritis) whereas out of 8 healthy volunteers with histological evidence of chronic antral gastritis, H. pylori was observed in 7 individuals (87.50%) (4 active chronic gastritis and 3 superficial chronic gastritis).Conclusion: A highly significant association between H. pylori infection with chronic antral gastritis both in peptic ulcer disease patients and healthy volunteers of Kashmir was found in this study. Association between H. pylori infection and chronic gastritis was 90% in peptic ulcer group and 87.50% in healthy population (P<0.005).

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The efficacy, safety, and tolerability of levofloxacin quadruple therapy for helicobacter pylori eradication: a randomized, double-blind clinical trial

10.21203/rs.3.rs-53307/v1 ◽

2020 ◽

Author(s):

Fariborz Mansour-Ghanaei ◽

Behnam Masihypour ◽

Mohammad Fathalipour ◽

Soheil Hassanipour ◽

Homayoon Sokhanvar ◽

...

Keyword(s):

Clinical Trial ◽

Helicobacter Pylori ◽

Alternative Therapy ◽

Double Blind ◽

Intention To Treat ◽

Bismuth Subcitrate ◽

Double Blind Clinical Trial ◽

End Of Treatment ◽

H Pylori ◽

To Receive

Abstract BackgroundThe incidence of microbial resistance is increasing, and new rescue regimens are needed in order to treat Helicobacter pylori (H. pylori) infection. To evaluate the efficacy, safety, and tolerability of levofloxacin based quadruple therapies in the eradication of H. pylori.MethodsIn a randomized, double-blind clinical trial, 220 patients with dyspepsia and H. pylori infection were randomly assigned to receive either bismuth subcitrate 240 mg, pantoprazole 20 mg, amoxicillin 1000 mg twice a day, and levofloxacin 500 mg daily for seven days (BPAL-7), or ten days (BPAL-10). The eradication of H. pylori was evaluated two months after the end of treatment, and adverse drug reactions (ADRs) were assessed during the intervention.ResultsAccording to intention-to-treat and per-protocol, the eradication rate was significantly lower in the BPAL-7 regimen 49.1% (95% CI: 39.3–57.8) and 47.6% (95% CI: 39.7–58.4), respectively compared to the BPAL- 10 regimen 62.7% (95% CI: 53.6–72.8) and 62.4% (95% CI: 55.1–72.8), respectively. The incidence of ADRs was not statistically significant between BPAL-7 (33.6%) and BPAL-10 (36.7%) groups.ConclusionAlthough the ADRs were negligible in both groups, these regimens could not be an ideal alternative therapy for H. pylori because of low eradication rates compared to standard regimens.Trial registration: The study reviewed and approved by the Iranian Registry of Clinical Trials (IRCT201406141155N19). This trial was retrospectively registered on July 10, 2015.

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The Efficacy, Safety, And Tolerability of Levofloxacin Quadruple Therapy For Helicobacter Pylori Eradication: A Randomized, Double-Blind Clinical Trial

10.21203/rs.3.rs-53307/v2 ◽

2021 ◽

Author(s):

Fariborz Mansour-Ghanaei ◽

Behnam Masihypour ◽

Mohammad Fathalipour ◽

Soheil Hassanipour ◽

Homayoon Sokhanvar ◽

...

Keyword(s):

Clinical Trial ◽

Helicobacter Pylori ◽

Alternative Therapy ◽

Double Blind ◽

Intention To Treat ◽

Bismuth Subcitrate ◽

Double Blind Clinical Trial ◽

End Of Treatment ◽

H Pylori ◽

To Receive

Abstract The incidence of microbial resistance is increasing, and new rescue regimens are needed in order to treat Helicobacter pylori (H. pylori) infection. To evaluate the efficacy, safety, and tolerability of levofloxacin based quadruple therapies in the eradication of H. pylori. In a randomized, double-blind clinical trial, 220 patients with dyspepsia and H. pylori infection were randomly assigned to receive either bismuth subcitrate 240 mg, pantoprazole 20 mg, amoxicillin 1000 mg twice a day, and levofloxacin 500 mg daily for seven days (BPAL-7), or ten days (BPAL-10). The eradication of H. pylori was evaluated two months after the end of treatment, and adverse drug reactions (ADRs) were assessed during the intervention. According to intention-to-treat and per-protocol, the eradication rate was significantly lower in the BPAL-7 regimen 49.1 % (95 % CI: 39.3-57.8) and 47.6 % (95 % CI: 39.7-58.4), respectively compared to the BPAL- 10 regimen 62.7 % (95 % CI: 53.6-72.8) and 62.4 % (95 % CI: 55.1-72.8), respectively. The incidence of ADRs was not statistically significant between BPAL-7 (33.6 %) and BPAL-10 (36.7 %) groups. Although the ADRs were negligible in both groups, these regimens could not be an ideal alternative therapy for H. pylori because of low eradication rates compared to standard regimens.Trial registration: The study reviewed and approved by the Iranian Registry of Clinical Trials (IRCT201406141155N19).

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