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 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 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 Evaluation of Convalescent Plasma Versus Standard of Care for the Treatment of COVID-19 in Hospitalized Patients: study protocol for a phase 2 randomized, open-label, controlled, multicenter trial

2020 ◽  
Author(s):  
Elena Diago-Sempere ◽  
Aranzazu Sancho-López ◽  
Jose Luis Bueno ◽  
Elena Múñez-Rubio ◽  
Ferran Torres ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Respiratory Infections ◽  
Controlled Trial ◽  
Viral Disease ◽  
Multicenter Trial ◽  
Adult Patients ◽  
Trial Registration ◽  
Ordinal Scale ◽  
Efficacy And Safety ◽  
Open Label

Abstract Background: COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. At the time this clinical trial was planned, there were no available vaccine or therapeutic agents with proven efficacy, but the severity of the condition prompted the use of several pharmacological and non-pharmacological interventions. It has long been hypothesized that the use of convalescent plasma (CP) from infected patients who have developed an effective immune response is likely to be an option for the treatment of patients with a variety of severe acute respiratory infections (SARI) of viral etiology. The aim of this study is to assess the efficacy and safety of convalescent plasma in adult patients with severe COVID-19 pneumonia. Methods/Design: The ConPlas-19 study is a multicenter, randomized, open-label controlled trial. The study has been planned to include 278 adult patients hospitalized with severe COVID-19 infection not requiring mechanical ventilation (invasive or non-invasive). Subjects are randomly assigned in a 1:1 ratio (139 per treatment arm), stratified by center, to receive intravenously administered CP (single infusion) plus SOC or SOC alone, and are to be followed for 30 days. The primary endpoint of the study is the proportion of patients that progress to categories 5, 6 or 7 (on the 7-point ordinal scale proposed by the WHO) at day 15. Interim analyses for efficacy and/or futility will be conducted once 20%, 40%, and 60% of the planned sample size are enrolled and complete D15 assessment.Discussion: This clinical trial is designed to evaluate the efficacy and safety of passive immunotherapy with convalescent plasma for the treatment of adult patients hospitalized with COVID-19. The results of this study are expected to contribute to establishing the potential place of CP in the therapeutics for a new viral disease. Trial registration: Trial registration at clinicaltrials.gov; Registration Number: NCT04345523; https://clinicaltrials.gov/ct2/show/NCT04345523; Registered on 30 March, 2020. First posted date: April 14, 2020.

scholarly journals Eradication of Helicobacter Pylori with Triple Therapy Comprising Probiotic & Proton Pump Inhibitor

2021 ◽  
pp. 703-709
Author(s):  
Hina Amjad ◽  
Sadia Sundus ◽  
. Ata-ur-Rehman ◽  
Kiran Khan ◽  
Ghazala Nasim Pasha ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Renal Function ◽  
Combination Therapy ◽  
Triple Therapy ◽  
Antigen Test ◽  
Stool Antigen Test ◽  
Positive Stool ◽  
Antigen Assay ◽  
Function Test ◽  
Stool Antigen

Objectives: The current clinical trial compared the effects of conventional triple therapy and probiotic (Lactobacillus reuteri) plus omeprazole combination in peptic ulcer patients. The secondary objectives included estimating the effects of these regimens on safety and tolerability. Study Design: Randomized clinical trial Abode and Period of Study: This was a six month research study conducted at the National Medical Centre, Karachi, Pakistan in October 2020 – March 2021. Materials & Methods: A total of 100 patients were recruited, had baseline positive stool antigen test. All the participants were separated into dual groups: conventional triple remedy (group A1) and probiotic with omeprazole combination (group B1). The study's primary endpoint was stool antigen assay and secondary included change in Hb, LFTs and renal function test. Results: The primary endpoints for combination therapy led to significantly greater reductions in positive stool antigen assay than triple therapy. This means that combination therapy is far better than triple therapy. The stool antigen test showed 56.5% positive and 43.5% negative in group A1 while in group B1 34.8% positive while 65.2% negative after treatment were seen with statistically significant difference (p=0.036). Insignificant findings were observed for level of Hb, LFTs and renal function test between both groups during the entire study. Conclusion: This is the first randomized clinical trial in peptic ulcer patients of Pakistan treated with probiotic plus omeprazole combination. Combination therapy was generally well-tolerated and effective in eradicating the Helicobacter pylori after initiation of therapy.

scholarly journals Omeprazole Once or Twice Daily with Clarithromycin and Metronidazole forHelicobacter pyloriEradicaiton in a Canadian Community Practice

2000 ◽  
Vol 14 (1) ◽  
pp. 27-31 ◽  
Author(s):  
Naoki Chiba ◽  
Cheryl P Marshall
Keyword(s):  
Side Effects ◽  
Triple Therapy ◽  
Community Practice ◽  
Taste Disturbance ◽  
Serious Adverse Events ◽  
Once Daily ◽  
Daily Group ◽  
First Line Therapy ◽  
H Pylori ◽  
Intent To Treat

BACKGROUND: Triple therapy for one week with omeprazole, clarithromycin and metronidazole (OCM) is accepted worldwide as a first line therapy forHelicobacter pylorieradication. It is unclear whether omeprazole needs to be given once or twice daily.OBJECTIVES: To assess the efficacy and safety of these regimens in a single-centre, Canadian practice.METHODS: Histologically provenH pylori-positive patients were treated for seven days with clarithromycin 250 mg bid and metronidazole 500 mg bid, and randomly allocated to omeprazole 20 mg either once or twice daily in this open, cohort study. Endoscopy with histology (two antrum and two body biopsies, Giemsa stain) was done four weeks or longer after the pills were completed to assessH pylorieradication.RESULTS: Whether omeprazole was given once or twice daily, eradication was high and the same in both arms. All-patients-treated eradication was 85% (39 of 46 in the omeprazole once daily group and 41 of 48 in the omeprazole twice daily group) and intent-to-treat eradication was 80% (39 of 49 in the omeprazole once daily group and 41 of 51 in the omeprazole twice daily group). Side effects were frequently seen, suffered by 65% to 69% of patients treated. However, these were mild and compliance was high, with 94% of patients taking all of their pills. Mild side effects included loose stools, taste disturbance, nausea, headache and upper or lower gastrointestinal gas. Only one patient (1%) from the omeprazole once daily arm stopped taking metronidazole due to excessive perspiring.CONCLUSIONS: In this community practice, OCM triple therapy was effective whether omeprazole was given once or twice daily. For those with financial constraint, omeprazole 20 mg once daily can be considered. The regimens were well tolerated without serious adverse events.

scholarly journals Evaluation of convalescent plasma versus standard of care for the treatment of COVID-19 in hospitalized patients: study protocol for a phase 2 randomized, open-label, controlled, multicenter trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Elena Diago-Sempere ◽  
José Luis Bueno ◽  
Aránzazu Sancho-López ◽  
Elena Múñez Rubio ◽  
Ferrán Torres ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Respiratory Infections ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Viral Disease ◽  
Multicenter Trial ◽  
Adult Patients ◽  
Ordinal Scale ◽  
Efficacy And Safety ◽  
Open Label

Abstract Background COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. At the time this clinical trial was planned, there were no available vaccine or therapeutic agents with proven efficacy, but the severity of the condition prompted the use of several pharmacological and non-pharmacological interventions. It has long been hypothesized that the use of convalescent plasma (CP) from infected patients who have developed an effective immune response is likely to be an option for the treatment of patients with a variety of severe acute respiratory infections (SARI) of viral etiology. The aim of this study is to assess the efficacy and safety of convalescent plasma in adult patients with severe COVID-19 pneumonia. Methods/design The ConPlas-19 study is a multicenter, randomized, open-label controlled trial. The study has been planned to include 278 adult patients hospitalized with severe COVID-19 infection not requiring mechanical ventilation (invasive or non-invasive). Subjects are randomly assigned in a 1:1 ratio (139 per treatment arm), stratified by center, to receive intravenously administered CP (single infusion) plus SOC or SOC alone, and are to be followed for 30 days. The primary endpoint of the study is the proportion of patients that progress to category 5, 6, or 7 (on the 7-point ordinal scale proposed by the WHO) at day 15. Interim analyses for efficacy and/or futility will be conducted once 20%, 40%, and 60% of the planned sample size are enrolled and complete D15 assessment. Discussion This clinical trial is designed to evaluate the efficacy and safety of passive immunotherapy with convalescent plasma for the treatment of adult patients hospitalized with COVID-19. The results of this study are expected to contribute to establishing the potential place of CP in the therapeutics for a new viral disease. Trial registration ClinicalTrials.gov NCT04345523. Registered on 30 March, 2020. First posted date: April 14, 2020.

scholarly journals Comparison of the effect of clarithromycin triple therapy with or without N-acetylcysteine in the eradication of Helicobacter pylori: a randomized controlled trial

2020 ◽  
Vol 13 ◽  
pp. 175628482092730
Author(s):  
Chieh-Chang Chen ◽  
Jiing-Chyuan Luo ◽  
Yu-Jen Fang ◽  
Ji-Yuh Lee ◽  
Chia-Chi Kuo ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Triple Therapy ◽  
Controlled Trial ◽  
Line Treatment ◽  
First Line ◽  
Open Label ◽  
Intention To Treat ◽  
Cyp2c19 Polymorphism ◽  
H Pylori ◽  
First Line Treatment

Background: Whether adjunctive N-acetylcysteine (NAC) may improve the efficacy of triple therapy in the first-line treatment of Helicobacter pylori infection remains unknown. Our aim was to compare the efficacy of 14-day triple therapy with or without NAC for the first-line treatment of H. pylori. Material and methods: Between 1 January 2014 and 30 June 2018, 680 patients with H. pylori infection naïve to treatment were enrolled in this multicenter, open-label, randomized trial. Patients were randomly assigned to receive triple therapy with NAC [NAC-T14, dexlansoprazole 60 mg four times daily (q.d.); amoxicillin 1 g twice daily (b.i.d.), clarithromycin 500 mg b.i.d., NAC 600 mg b.i.d.] for 14 days, or triple therapy alone (T14, dexlansoprazole 60 mg q.d.; amoxicillin 1 g b.i.d., clarithromycin 500 mg b.i.d.) for 14 days. Our primary outcome was the eradication rates by intention to treat (ITT). Antibiotic resistance and CYP2C19 gene polymorphism were determined. Results: The ITT analysis demonstrated H. pylori eradication rates in NAC-T14 and T14 were 81.7% [276/338, 95% confidence interval (CI): 77.5–85.8%] and 84.3% (285/338, 95% CI 80.4–88.2%), respectively. In 646 participants who adhered to their assigned therapy, the eradication rates were 85.7% and 88.0% with NAC-T14 and T14 therapies, respectively. There were no differences in compliance or adverse effects. The eradication rates in subjects with clarithromycin-resistant, amoxicillin-resistant, or either clarithromycin/amoxicillin resistant strains were 45.2%, 57.9%, and 52.2%, respectively, for NAC-T14, and were 66.7%, 76.9%, and 70.0%, respectively, for T14. The efficacy of NAC-T14 and T14 was not affected by CYP2C19 polymorphism. Conclusion: Add-on NAC to triple therapy was not superior to triple therapy alone for first-line H. pylori eradication [ClinicalTrials.gov identifier: NCT02249546].

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