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Effects of cranberry beverages on oxidative stress and gut microbiota in subjects with Helicobacter pylori infection: a randomized, double-blind, placebo-controlled trial.
Gao, T, Hou, M, Zhang, B, Pan, X, Liu, C, Sun, C, Jia, M, Lin, S, Xiong, K, Ma, A
Food & function. 2021;(15):6878-6888
Abstract
Helicobacter pylori-induced oxidative stress plays an important role in gastric diseases. H. pylori disturbs gut microbiota. The objective is to investigate the effects of cranberry beverages on oxidative stress biomarkers and gut microbiota in H. pylori positive subjects. 171 H. pylori positive participants were randomly assigned to one of the three groups: high-dose (HCb; 480 mL cranberry beverage), low-dose (LCb; 240 mL cranberry beverage plus 240 mL placebo) and placebo (480 mL). Subjects consumed the beverages daily for 4 weeks. Fasting blood samples were analyzed for oxidative stress biomarkers. The intestinal microbiome was analyzed by 16S rRNA sequencing. Compared with the placebo, HCb resulted in a significantly higher increase of total antioxidant capacity (mean ± SD: 1.39 ± 1.69 IU mL-1vs. 0.34 ± 1.73 IU mL-1; p < 0.001) and a higher decrease of the lipid peroxidation product malondialdehyde (-7.29 ± 10.83 nmol mg-1vs. -0.84 ± 15.66 nmol mg-1; p = 0.025). A significant dose-dependent effect on the elevation of superoxide dismutase was observed (p < 0.001). Microbiome data showed that consuming HCb and LCb led to a significant reduction of Pseudomonas (p < 0.05). In conclusion, the current research showed that consuming cranberry beverages significantly improved the antioxidant status in H. pylori positive subjects, which may be related to the reshaping of gut microbiota.
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Identifying the best regimen for primary eradication of Helicobacter pylori: analysis of 240 cases.
Chen, Y, Liu, Q, Hu, F, Ma, J
MicrobiologyOpen. 2020;(11):e1120
Abstract
The treatment regimen for the eradication of Helicobacter pylori may be best when therapy is susceptibility guided. However, it is unrealistic to use a strategy based on susceptibility testing to prioritize therapy for every patient in China. Empirical therapy of H. pylori is still widely used. The study was designed to discuss the best first-line treatment regimen depending on empirical therapy. The focal point of the study was the optimal length of the therapy. Also, the selection of antibiotics was discussed in the article. This was a prospective, randomized, non-inferiority trial. H. pylori-infected patients who have no previous eradication therapy were randomly assigned to the following: 20 mg of rabeprazole, 1000 mg of amoxicillin, 500 mg of clarithromycin, and 220 mg of bismuth potassium citrate (BACPPI), administered twice a day for 10 or 14 days. The efficacy, side effects, and remission rate of clinical symptoms were determined. A total of 240 subjects were included in the study. The eradication rate with 14 and 10 days was essentially identical in both intention-to-treat (90.83% [95% CI, 86%-96%] vs. 87.50% [95% CI, 82%-93%]) and per-protocol (94.78% [95% CI, 91%-99%] vs. 92.11% [95% CI, 87%-97%]) analyses. Loss of appetite and belching symptoms were significantly better in the BACPPI-10 group than those in the control group after treatment. Side effects were generally mild and similar between groups. Our results showed that a 10-day amoxicillin-clarithromycin-containing bismuth quadruple therapy may be recommended for the primary empirical treatment of H. pylori infection in Beijing, China.
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Vonoprazan-Based Regimen Is More Useful than PPI-Based One as a First-Line Helicobacter pylori Eradication: A Randomized Controlled Trial.
Maruyama, M, Tanaka, N, Kubota, D, Miyajima, M, Kimura, T, Tokutake, K, Imai, R, Fujisawa, T, Mori, H, Matsuda, Y, et al
Canadian journal of gastroenterology & hepatology. 2017;:4385161
Abstract
Background. A new agent, potassium-competitive acid blocker vonoprazan (VPZ) has potent acid-inhibitory effects and may offer advantages over conventional H. pylori eradication therapies. We aimed to compare the eradication rate between VPZ-based treatment and PPI-based one. Methods. This randomized controlled trial was designed to assign 141 patients with H. pylori-positive gastritis to VPZ group (VPZ 20 mg, amoxicillin 750 mg, and clarithromycin 200 or 400 mg twice daily for 7 days) or PPI group (rabeprazole 20 mg or lansoprazole 30 mg, amoxicillin 750 mg, and clarithromycin 200 or 400 mg twice daily for 7 days). Primary endpoints were eradication rates and adverse events. Results. Seventy of 72 patients in VPZ group and 63 of 69 patients in PPI group completed the treatment after 7 days. The eradication rate was significantly higher in VPZ group than PPI group by intention-to-treat analysis (95.8% versus 69.6%, P = 0.00003, 95% confidence interval [CI] 88.3-99.1% versus 57.3-80.1%) and per-protocol analysis (95.7% versus 71.4%, P = 0.0002, 95% CI 88.0-99.1% versus 58.7-82.1%). The incidence of adverse events was not different between the groups (26.3% in VPZ group versus 37.7% in PPI group, P = 0.15). Conclusion. VPZ-based regimen is more useful than that PPI-based regimen as a first-line H. pylori eradication therapy.
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Pharmacokinetics and Safety of Triple Therapy with Vonoprazan, Amoxicillin, and Clarithromycin or Metronidazole: A Phase 1, Open-Label, Randomized, Crossover Study.
Sakurai, Y, Shiino, M, Okamoto, H, Nishimura, A, Nakamura, K, Hasegawa, S
Advances in therapy. 2016;(9):1519-35
Abstract
INTRODUCTION Vonoprazan (TAK-438) is a novel potassium-competitive acid blocker that inhibits gastric H(+), K(+)-ATPase. The objectives of this study were to evaluate the influence of triple therapy with vonoprazan-amoxicillin-clarithromycin or vonoprazan-amoxicillin-metronidazole on the pharmacokinetics of each component of the triple therapies (primary) and to evaluate the safety and tolerability of vonoprazan-based triple therapies (secondary) in healthy adults. METHODS In this single-center, phase 1, open-label, randomized, four-way crossover study, Helicobacter pylori-negative, healthy Japanese male subjects were randomly assigned to 1 of 4 treatment sequences in two cohorts (12 subjects per cohort). Each treatment sequence comprised four treatment periods separated by a washout period of 7 or 14 days. Pharmacokinetic parameters for vonoprazan, amoxicillin, clarithromycin and metronidazole in single therapy or triple therapies were assessed. All adverse events were recorded. RESULTS Compared with single therapy, triple therapy with vonoprazan-amoxicillin-clarithromycin increased the area under the plasma concentration-time curve from time 0-12 h (AUC0-12) and maximum plasma concentration (C max) of plasma vonoprazan free base by 1.846- and 1.868-fold, respectively, and increased the AUC0-12 and C max of plasma clarithromycin by 1.450- and 1.635-fold, respectively. Triple therapy with vonoprazan-amoxicillin-metronidazole had no influence on the pharmacokinetics of vonoprazan or metronidazole. The pharmacokinetics of amoxicillin was not influenced by vonoprazan-based triple therapies. Seven adverse events were reported. Two subjects discontinued because of an adverse event (rash, liver function test abnormal); both events were considered to be study drug-related. CONCLUSION In healthy Japanese male subjects, triple therapy with vonoprazan-amoxicillin-clarithromycin increased vonoprazan and clarithromycin exposure. The safety and tolerability profile of triple therapy with vonoprazan-amoxicillin-clarithromycin or vonoprazan-amoxicillin-metronidazole was favorable in this population. FUNDING Takeda Pharmaceutical Company Ltd. TRIAL REGISTRATION JapicCTI-153102.
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Bismuth, lansoprazole, amoxicillin and metronidazole or clarithromycin as first-line Helicobacter pylori therapy.
Zhang, W, Chen, Q, Liang, X, Liu, W, Xiao, S, Graham, DY, Lu, H
Gut. 2015;(11):1715-20
Abstract
OBJECTIVE To evaluate the efficacy and tolerability of replacing tetracycline with amoxicillin in bismuth quadruple therapy. DESIGN Subjects who were infected with Helicobacter pylori and naïve to treatment were randomly (1:1) assigned to receive a 14-day modified bismuth quadruple therapy: lansoprazole 30 mg, amoxicillin 1 g, bismuth potassium citrate 220 mg (elemental bismuth), twice a day with metronidazole 400 mg four times a day (metronidazole group) or clarithromycin 500 mg twice a day (clarithromycin group). Six weeks after treatment, H. pylori eradication was assessed by 13C-urea breath test. Antimicrobial susceptibility was assessed by the twofold agar dilution method. This was a non-inferiority trial. RESULTS Two hundred and fifteen subjects were randomised. Metronidazole and clarithromycin containing regimens achieved high cure rates: 94 of 97 (96.9%, 95% CI 93.5% to 100%) and 93 of 98 (94.9%, 95% CI 90.5% to 99.3%) by per-protocol and 88.9% (95% CI 83.0% to 94.8%) and 88.8% (95% CI 82.8% to 94.8%) by intention-to-treat, respectively. Amoxicillin, metronidazole and clarithromycin resistance rates were 1.5%, 45.5% and 26.5%, respectively. Only clarithromycin resistance reduced treatment success (e.g., susceptible 98.6%, resistant 76.9%, p=0.001). Adverse events were more common in the metronidazole group. CONCLUSIONS These results suggest that amoxicillin can substitute for tetracycline in modified 14 day bismuth quadruple therapy as first-line treatment and still overcome metronidazole resistance in areas with high prevalence of metronidazole and clarithromycin resistance. Using clarithromycin instead of metronidazole was only effective in the presence of susceptible strains. TRIAL REGISTRATION NUMBER NCT02175901.
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Significant Reduction in Helicobacter pylori Load in Humans with Non-viable Lactobacillus reuteri DSM17648: A Pilot Study.
Holz, C, Busjahn, A, Mehling, H, Arya, S, Boettner, M, Habibi, H, Lang, C
Probiotics and antimicrobial proteins. 2015;(2):91-100
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Abstract
Reducing the amount of Helicobacter pylori in the stomach by selective bacterial-bacterial cell interaction was sought as an effective and novel method for combating the stomach pathogen. Lactobacillus reuteri DSM17648 was identified as a highly specific binding antagonist to H. pylori among more than 700 wild-type strains of Lactobacillus species. Applying a stringent screening procedure, the strain DSM17648 was identified as selective binder to H. pylori cells under in vivo gastric conditions. The strain DSM17648 co-aggregates the pathogen in vivo and in vitro. The specific co-aggregation occurs between Lact. reuteri DSM17648 and different H. pylori strains and serotypes, as well as H. heilmannii, but not with Campylobacter jejuni or other commensal oral and intestinal bacteria. Lact. reuteri DSM17648 was shown in a proof-of-concept single-blinded, randomized, placebo-controlled pilot study to significantly reduce the load of H. pylori in healthy yet infected adults. Reducing the amount of H. pylori in the stomach by selective bacterial-bacterial cell interaction might be an effective and novel method for combating the stomach pathogen. Lact. reuteri DSM17648 might prove useful as an adhesion blocker in antibiotic-free H. pylori therapies.
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Phytomedicine-based and Quadruple Therapies in Helicobacter pylori Infection: A Comparative, Randomized Trial.
Asif, HM, Zaidi, SF, Sugiyama, T, Akhtar, N, Usmanghani, K
Alternative therapies in health and medicine. 2015;:33-9
Abstract
CONTEXT Helicobacter pylori (H pylori) is strongly associated with the development of gastritis, duodenal and gastric ulcers, gastric mucosa-associated lymphoid tissue (MALT) lymphomas and gastric carcinoma. Emerging antibiotic resistance and patients' poor compliance with modern therapies have resulted in increasing eradication failure. OBJECTIVES The current trial was conducted to evaluate the efficacy of current quadruple and phytomedicine-based therapies for the eradication of H pylori infection and relief of its associated symptoms in Pakistan. DESIGN The study was a randomized, controlled, multicenter clinical trial. Setting • The study was conducted in high-risk areas of Pakistan, including at Shifa-Ul-Mulk Memorial Hospital in Karachi, at Bahawalpur Victoria Hospital in Bahawalpur, and at Nawaz Salik Hospital in Rawalpindi. PARTICIPANTS The study enrolled 210 patients who tested positive for H pylori, 118 males and 92 females. INTERVENTION Participants were divided into 2 groups according to treatment regimens. One group of participants received quadruple therapy-20 mg of omeprazole, 1g of amoxicillin, 500 mg of metronidazole, and 400 mg of bismuth compound-that was prescribed for 7 d, and another group received an alternate, phytomedicine-based, quadruple formulation-500 mg of Pylorex Plus-that was prescribed for 15 d. OUTCOME MEASURES The eradication rate for H pylori was the primary outcome measure. Eradication was considered to be achieved on the basis of a negative C-urea breath test (UBT) and a negative stool antigen test for H pylori (HpSAg) at 4 wk after the end of treatment. The secondary outcome measure was the improvement in the clinical features as assessed by dyspepsia scores. RESULTS In an intention-to-treat (ITT) analysis, the study found that H pylori was eradicated in 56 of the 90 participants in the quadruple therapy group who completed the study (62.2%) and in 48 of the 86 participants in the Pylorex Plus group who completed the study (55.8%). Therefore, Pylorex Plus had an eradication rate comparable with quadruple therapy. However, Pylorex Plus had significantly reduced gastrointestinal (GI) symptoms at the second wk and at 1 mo after treatment, both for participants in whom H pylori was eradicated and for those in whom it was not eradicated. The quadruple therapy group also showed reduced GI symptoms at the second wk and at 1 mo after treatment, but that result occurred only for those participants in whom H pylori was eradicated, and no significant improvement was observed for participants in whom it was not eradicated. CONCLUSIONS Current quadruple and alternate therapies yielded poor eradication rates (<70%), but the latter produced marked symptomatic improvement, both for participants in whom H pylori was eradicated and for those in whom it was not eradicated, pointing out its potential use with patients with functional dyspepsia (FD) who are both positive and negative for H pylori.
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Probiotics for standard triple Helicobacter pylori eradication: a randomized, double-blind, placebo-controlled trial.
Hauser, G, Salkic, N, Vukelic, K, JajacKnez, A, Stimac, D
Medicine. 2015;(17):e685
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Abstract
The primary objective in the study is determination of efficacy of probiotic preparation as a supportive therapy in eradication of Helicobacter pylori.The study was multicenter, prospective, randomized, placebo controlled, and double-blind. The subjects first filled out a specially designed questionnaire to assess the severity of the 10 symptoms, which can be related to eradication therapy to be monitored during the trial. Each subject then received 28 capsules of probiotic preparation or matching placebo capsules, which they were supposed to take over the following 14 days, twice a day, at least 2 hours prior to or after the antibiotic therapy administration.A total of 804 patients were enrolled in the trial, of which 650 (80.85%) were included in the analysis. The results show a significantly larger share of cured subjects in the probiotic arm versus the placebo arm (87.38% vs 72.55%; P < 0.001). Additionally, presence and intensity of epigastric pain, bloating, flatulence, taste disturbance, loss of appetite, nausea, vomiting, heartburn, rash, and diarrhea were monitored over the study period. At 15 days postinclusion, probiotic treatment was found superior to placebo in 7 of 10 mentioned symptoms. Average intensity for symptoms potentially related to antibiotic therapy was significantly higher in the placebo group, 0.76 vs 0.55 (P < 0.001).Adding probiotics to the standard triple therapy for H pylori eradication significantly contributes to treatment efficacy and distinctly decreases the adverse effects of therapy and the symptoms of the underlying disease.
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[Lactobacillus rhamnosus GG supplementation to reduce side-effects of anti-Helicobacter pylori treatment].
Padilla Ruiz, M, Fernández Aguiar, ME, Arce Nuñez, M, Polo Amorín, R
Revista de gastroenterologia del Peru : organo oficial de la Sociedad de Gastroenterologia del Peru. 2013;(2):121-30
Abstract
BACKGROUND Helicobacter pylori (Hp) eradication fails in about 10% of patients because of the occurrence of resistance to antibiotics and side-effects. During anti H.pylori therapy, probiotics have been used to reduce the incidence of side-effects. OBJECTIVES To determine whether adding the probiotic Lactobacillus rhamhousus GG to an anti-H. pylori regimen could help to prevent or minimize the gastrointestinal side-effect burden. MATERIAL AND METHODS 66 subjects screening positive for H. pylori infection (male/female: 45/21, mean age 56,6 DS ± 16,7 year ), 59 subjects receiving 7 days of Omeprazole 20 mg b.i.d, Amoxicillin 1000 mg b.i.d and Clarithromycin 500 mg b.i.d were randomly assigned to Lactobacillus rhamnosus GG (6 x 9 ufc b.i.d ) (n = 29) or placebo (n = 30). Patients completed questionnaires after the treatment to determine the type and 10 severity of side-effects. RESULTS Side effects occurred mainly during the eradication therapy; none of them caused therapy discontinuation. Bloating, diarrhea, taste disturbance and epigastric discomfort were the most frequent side effects: (10.3% versus 16%, 13.8% versus 20%, 13.7% versus 20% and 13.7 % versus 20% respectively). No significant differences were found between the two groups for individual symptoms. CONCLUSION In this study, probiotic supplementation did not diminish significantly the frequency of new or aggravated symptoms during H. pylori eradication.
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Non-viable Lactobacillus reuteri DSMZ 17648 (Pylopass™) as a new approach to Helicobacter pylori control in humans.
Mehling, H, Busjahn, A
Nutrients. 2013;(8):3062-73
Abstract
Prevalence of infections by Helicobacter pylori, a pathogen involved in a number of gastrointestinal diseases, remains high in developing countries. Management of infections by eradication is not always an option. Lactobacillus reuteri (L. reuteri) DSMZ17648 (Pylopass™/Lonza) specifically co-aggregates H. pylori in vitro and was shown to reduce ¹³C urea breath test in vivo. In this pilot study, we tried to replicate previous findings in an independent sample and to evaluate effects of spray-drying vs. freeze-drying of cultures. A single-blinded, placebo-controlled study was done in 22 H. pylori positive, asymptomatic adults. H. pylori levels were determined by ¹³C-urea-breath method after 14 days of supplementation, as well as after 6, 12, and 24 weeks follow-up. In the test group, but not in the placebo group, a significant reduction of H. pylori was observed. For the first time, spray-dried cells of L. reuteri DSMZ17648 have been used in a human study and results are in line with the first study results, supplementing with freeze-dried material. This is of special interest as spray-drying results in dead cell material, meaning that the effect of L. reuteri must be independent of its probiotic activity. These results confirm the potential of Pylopass™ as a novel way to reduce the load of H. pylori.