Efficacy and safety of rifaximin associated with standard triple therapy (omeprazole, clarithromycin and amoxicillin) for H. pylori eradication: A phase IV pilot clinical trial

2017 ◽  
Vol 40 (10) ◽  
pp. 658-662 ◽  
Author(s):  
Mercedes Ramas ◽  
Maria G. Donday ◽  
Adrian G. McNicholl ◽  
Javier P. Gisbert
Keyword(s):  
Clinical Trial ◽  
Triple Therapy ◽  
Efficacy And Safety ◽  
Standard Triple Therapy ◽  
H Pylori ◽  
Phase Iv

scholarly journals Standard Triple Therapy versus Sequential Therapy inHelicobacter pyloriEradication: A Double-Blind, Randomized, and Controlled Trial

2015 ◽  
Vol 2015 ◽  
pp. 1-5 ◽  
Author(s):  
Jaime Natan Eisig ◽  
Tomás Navarro-Rodriguez ◽  
Ana Cristina Sá Teixeira ◽  
Fernando Marcuz Silva ◽  
Rejane Mattar ◽  
...  
Keyword(s):  
Triple Therapy ◽  
Controlled Trial ◽  
Sequential Therapy ◽  
Rapid Urease Test ◽  
Double Blind ◽  
Intention To Treat ◽  
Standard Triple Therapy ◽  
Urease Test ◽  
H Pylori ◽  
Triple Treatment

Aim. To compare 10-day standard triple therapy versus sequential therapy as first-line treatment in patients infected withH. pylori.Methods. One hundredH. pyloripositive patients (diagnosed by rapid urease test and histology), with average age of 47.2, M/F = 28/72, were randomized to receive either standard triple treatment (TT) as follows: lansoprazole 30 mg, clarithromycin 500 mg, and amoxicillin 1 g, b.i.d. for ten days, or sequential treatment (ST) as follows: lansoprazole 30 mg, amoxicillin and placebo 1.0 g b.i.d for the first five days, followed by lansoprazole 30 mg, clarithromycin 500 mg, and tinidazole 500 mg b.i.d, for the remaining five days. Eradication rates were determined 60 days after treatment by urease, histology, or13C-urea breath test.Results. In intention to treat (ITT) analysis, the rate ofH. pylorieradication in the TT and ST groups was the same for both regimens as follows: 86% (43/50), 95% CI 93,3 to 73.4%. In Per protocol (PP) analysis, the rate ofH. pylorieradication in the TT and ST groups was 87.8% (43/49), 95% CI 94,5 to 75.3% and 89.6% (43/48), 95% CI 95,8 to 77.3%, respectively.Conclusions. In Brazil, standard triple therapy is as equally effective as sequential therapy in eradicatingHelicobacter pyloripatients. This study was registered under Clinical Trials with numberISRCTN62400496.

scholarly journals Results of an open-label, randomized, comparative clinical trial of nifuratel in the eradication of Helicobacter pylori infection in adult patients

2020 ◽  
Vol 22 (2) ◽  
pp. 119-127
Author(s):  
Natalya N. Dekhnich ◽  
A.A. Tryapyshko ◽  
Ivan V. Trushin ◽  
Alexey Yu. Kuzmenkov ◽  
Roman S. Kozlov
Keyword(s):  
Clinical Trial ◽  
Triple Therapy ◽  
Adult Patients ◽  
Study Group ◽  
Open Label ◽  
Comparative Clinical Trial ◽  
Stool Antigen Test ◽  
Comparator Group ◽  
H Pylori ◽  
Intent To Treat

Objective. To assess efficacy and safety of 14-day triple nifuratel-based therapy compared to 14-day standard triple therapy in adult patients with symptomatic H. pylori infection. Materials and Methods. A total of 70 patients with dyspepsia and microbiologically confirmed H. pylori infection were enrolled into the open-label, randomized, comparative clinical trial. The study group (n = 35) received a 14-day triple nifuratel-based therapy: esomeprazole (20 mg BID), nifuratel (400 mg BID) and amoxicillin (1000 mg BID). The comparator group (n = 35) received 14-day conventional clarithromycinbased triple therapy: esomeprazole (20 mg BID), clarithromycin (500 mg BID) and amoxicillin (1000 mg BID). Eradication of H. pylori was assessed using stool antigen test. Results. Eradication rates for 14-day nifuratel-based triple therapy and 14-day clarithromycin-based triple therapy in the intent-to-treat (ITT) population were 82.9% and 74.3% (p = 0.561), respectively. In the per-protocol (PP) population, eradication rates were 90.6% and 89.7% (p = 1.00), respectively. Adverse events were reported in 17.1% of patients in the study group and 34.3% of patients in the comparator group (p > 0.05). Conclusions. The 14-day triple nifuratel-based therapy has demonstrated a high H. pylori eradication rate (above 90%). Nifuratel triple therapy may be considered as an alternative to clarithromycin-based triple therapy for patients with a history of the prior macrolide exposure or macrolide intolerance.

scholarly journals 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

2019 ◽  
Vol 91 (8) ◽  
pp. 28-33 ◽  
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.

scholarly journals The Effects of Synbiotic “Bifidobacterium lactisB94 plus Inulin” Addition on Standard Triple Therapy ofHelicobacter pyloriEradication in Children

2017 ◽  
Vol 2017 ◽  
pp. 1-6 ◽  
Author(s):  
Gonca Handan Ustundag ◽  
Halime Altuntas ◽  
Yasemin Dilek Soysal ◽  
Furuzan Kokturk
Keyword(s):  
Triple Therapy ◽  
Standard Therapy ◽  
Therapy Group ◽  
Symptom Relief ◽  
Standard Therapy Group ◽  
Bifidobacterium Lactis ◽  
Standard Triple Therapy ◽  
H Pylori ◽  
Intent To Treat ◽  
Infection Eradication

Aim. The aim of this study is to evaluate the effects of the synbioticBifidobacterium lactisB94 plus inulin addition to the standard triple therapy onHelicobacter pylori (H. pylori)infection eradication rates.Methods. Children aged 6–16 years who had biopsy provenH. pyloriinfection were randomly classified into two groups. The first group received the standard triple therapy consisting of amoxicillin + clarithromycin + omeprazole. The second group was treated with the standard triple therapy andBifidobacterium lactisB94 (5 × 109 CFU/dose) plus inulin (900 mg) for 14 days, concurrently. Eradication was determined by14C-urea breath test 4–6 weeks after therapy discontinuation.Results. From a total of 69H. pyloriinfected children (F/M = 36/33; mean ± SD = 11.2 ± 3.0 years), eradication was achieved in 20/34 participants in the standard therapy group and 27/35 participants in the synbiotic group. The eradication rates were not significantly different between the standard therapy and the synbiotic groups [intent-to-treat, 58.8% and 77.1%, resp.,p= 0.16; per-protocol, 64.5% and 81.8%, resp.,p= 0.19]. There was no difference between the groups in terms of symptom relief (p= 0.193). The reported side effects were ignorable.Conclusion. Considering the eradication rates, synbiotic addition to therapy showed no superiority over the standard triple therapy conducted alone. This trial is registered withNCT03165253.

scholarly journals CURCUMIN IN COMBINATION WITH TRIPLE THERAPY REGIMES AMELIORATES OXIDATIVE STRESS AND HISTOPATHOLOGIC CHANGES IN CHRONIC GASTRITIS-ASSOCIATED HELICOBACTER PYLORI INFECTION

2017 ◽  
Vol 54 (3) ◽  
pp. 177-182 ◽  
Author(s):  
Arezu JUDAKI ◽  
Asghar RAHMANI ◽  
Jalil FEIZI ◽  
Khairollah ASADOLLAHI ◽  
Mohammad Reza HAFEZI AHMADI
Keyword(s):  
Oxidative Stress ◽  
Helicobacter Pylori ◽  
Triple Therapy ◽  
Chronic Gastritis ◽  
Therapy Group ◽  
Standard Triple Therapy ◽  
Before And After ◽  
Total Antioxidant ◽  
H Pylori ◽  
Triple Regimen

ABSTRACT BACKGROUND Helicobacter pylori (H. pylori) gastric infection is a main cause of inflammatory changes and gastric cancers. OBJECTIVE The aim of this study was finding the effects of curcumin on oxidative stress and histological changes in chronic gastritis associated with H. pylori. METHODS In a randomized clinical trial, patients were divided into two groups: a standard triple therapy group and triple therapy with curcumin group. Endoscopic and histological examinations were measured for all patients before and after 8 weeks. RESULTS Triple therapy with curcumin treatment group significantly decreased malondialdehyde markers, glutathione peroxides and increased total antioxidant capacity of the gastric mucosa at the end of study compared to baseline and triple regimen groups. In addition, the oxidative damage to DNA was significantly decreased in triple therapy with curcumin group at the end of study compared to baseline and compared to triple therapy (P<0.05 for both). Triple therapy group in combination with Curcumin significantly decreased all active, chronic and endoscopic inflammation scores of patients compared to the baseline and triple therapy group (P<0.05 for both). The eradication rate by triple therapy + curcumin was significantly increased compared to triple therapy alone (P<0.05). CONCLUSION Curcumin can be a useful supplement to improve chronic inflammation and prevention of carcinogenic changes in patients with chronic gastritis associated by H. pylori.

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