scholarly journals Bovine Antibody-Based Oral Immunotherapy for Reduction of Intragastric Helicobacter pylori Colonization: A Randomized Clinical Trial

2011 ◽  
Vol 25 (4) ◽  
pp. 207-213 ◽  
Author(s):  
CM den Hoed ◽  
AC de Vries ◽  
PBF Mensink ◽  
CM Dierikx ◽  
H Suzuki ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Helicobacter Pylori ◽  
Randomized Clinical Trial ◽  
Bacterial Load ◽  
Oral Immunotherapy ◽  
Whey Protein Concentrate ◽  
Effective Prevention ◽  
Significant Difference ◽  
H Pylori ◽  
Bovine Antibody

BACKGROUND: Antibiotic-based regimens are frequently used for the treatment of Helicobacter pylori infection. These regimens fail to eradicate H pylori in 15% to 40% of patients, primarily due to antimicrobial resistance and insufficient patient compliance. Effective prevention and eradication of H pylori by passive immunization with orally administered bovine antibodies has been demonstrated in animal studies, and may serve as an alternative therapy in humans.OBJECTIVE: To study the efficacy and safety of orally administered bovine anti-H pylori antibodies for the reduction of intragastric bacterial load and eradication of H pylori in humans.METHODS: Dairy cows were immunized against H pylori. After confirmation of the presence of anti-H pylori antibodies in the milk, the milk was subsequently processed into a whey protein concentrate (WPC). In a prospective, double-blind, placebo-controlled randomized clinical trial, H pylori-infected subjects were randomly assigned to treatment with the WPC preparation or placebo. Study medication was continued for 28 days; subjects were followed-up for 56 days.RESULTS: Of the 30 subjects included, 27 completed the protocol. Of these 27 evaluable subjects, 14 were treated with WPC and 13 with placebo. There was no significant difference in urea breath test decrease between the WPC- and placebo-treated group (P=0.75). H pylori-associated gastritis and density were not significantly reduced in either group after treatment (P>0.05 for all).CONCLUSION: Bovine antibody-based oral immunotherapy appears to be safe, but does not significantly reduce intragastric H pylori density in humans. Further studies are needed to determine whether WPC treatment has additional value to conventional antibiotic treatment for H pylori.

M1085 Bovine Antibodies-Based Oral Immunotherapy for Reduction of Intragastric Helicobacter pylori Bacterial Load: A Randomized Placebo-Controlled Clinical Trial

2008 ◽  
Vol 134 (4) ◽  
pp. A-335
Author(s):  
Annemarie C. de Vries ◽  
Peter B. Mensink ◽  
Cindy Dierikx ◽  
Herman van Dekken ◽  
Ernst J. Kuipers
Keyword(s):  
Clinical Trial ◽  
Helicobacter Pylori ◽  
Bacterial Load ◽  
Oral Immunotherapy ◽  
Controlled Clinical Trial

scholarly journals The Effect of Oral Administration of Pistacia Atlantica Kurdica Gum on the Eradication of Helicobacter Pylori in Patients with Dyspepsia: A Randomized Clinical Trial

2016 ◽  
Vol 9 (2) ◽  
pp. 256 ◽  
Author(s):  
Hamidollah Afrasiabian ◽  
Mohammad Hadi Imanieh ◽  
Mohammad Ali Nejati ◽  
Alireza Salehi
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Demographic Situation ◽  
Significant Difference ◽  
Before And After ◽  
Group A ◽  
H Pylori ◽  
Group B ◽  
Group D ◽  
Common Infections

<p><em>H. pylori</em><strong> </strong>infection is one of the most common infections in the world so that the aim of this study was to evaluate the antimicrobial <em>P. Atlantica Kurdica</em> gum in the eradication of <em>H. pylori</em>. This study is a randomized clinical trial; Patients with positive Urea Breath Test and symptoms of dyspepsia were entered. Patients were randomly divided into four groups. Group A: three drugs including 500 mg of Amoxicillin twice a day (bd), Clarithromycin 500 mg bd and Omeprazole 20 mg (bd) and Group B: Group A drugs plus the capsule containing 1 g of powdered <em>P. Atlantica Kurdica </em>gum (bd). In Group C: the capsule containing 1 g of powdered <em>P. Atlantica Kurdica</em> gum (bd) and Group D: this group took placebo-containing capsule (bd) for 14 days respectively. Dyspeptic symptoms before and after healing period and the UBT results two days before the start of treatment and 30 days after the completion were compared in 4 groups. Patients were not statistically significant difference from each other in the four groups regarding the demographic situation. Moreover, <em>H. pylori</em> eradication rate was 19/24 in Group A, 18/24 in Group B, 10/23 in Group C and 2/24 in Group D. Relieving symptoms of dyspepsia in Groups B and C were significantly higher than in Group D (P=0.025 and p=0.006 respectively). <em>P. Atlantica Kurdica</em> significantly led to the treatment of dyspepsia symptoms and <em>H. pylori</em> eradication.</p>

scholarly journals Clarithromycin versus levofloxacin-based regimens for Helicobacter pylori eradication in the Kurdistan Region of Iraq: A randomized clinical trial

2019 ◽  
Vol 10 (1) ◽  
Author(s):  
Shinah A. Mohammed ◽  
Omer Q. B. Al-lela ◽  
Nawfal R. Hussein ◽  
Ramadhan S. Hajany ◽  
Laween S. Alduhoky
Keyword(s):  
Clinical Trial ◽  
Helicobacter Pylori ◽  
Randomized Clinical Trial ◽  
Rapid Urease Test ◽  
Predisposing Factor ◽  
Helicobacter Pylori Eradication ◽  
Factors Associated ◽  
Urease Test ◽  
H Pylori ◽  
Resistance Rates

Helicobacter pylori infection is a predisposing factor for gastric cancer. This prospective, randomized clinical trial aimed to compare H. pylori eradication rates associated with a clarithromycin-based regimen and levofloxacin-based regimen. H. pylori infection was confirmed by a rapid urease test during endoscopy and its eradication by a urea breath test. In this study, 192 patients were recruited; 93 patients received a clarithromycin- based regimen and 99 a levofloxacin- based regimen. Sixty-four patients completed the clarithromycinbased regimen and 60 the levofloxacinbased regimen. The eradication success rate of the clarithromycin-based regimen was 52/64 (81.25%), while that of the levofloxacin- based regimen was 49/60 (81.6%) (P=0.9524; odds ratio [OR]=1.0280; confidence interval [CI]=0.4153-2.5447). Investigation of the risk factors associated with treatment failure showed that the overall efficacy of the regimens was influenced by body mass index (BMI), with a high failure rate observed in patients with a high BMI (P=0.0174; OR=1.1116; CI=1.0187- 1.2129). Age, sex, endoscopic diagnosis and smoking did not influence treatment outcomes. Further studies are needed to monitor H. pylori antibiotic resistance rates.

scholarly journals Atorvastatin and standard treatment of Helicobacter pylori: Single Blinded Randomized Controlled Clinical Trial

2020 ◽  
Author(s):  
Mohammad Reza Mohammad Hoseini Azar ◽  
Parham Portaghali ◽  
Ali Jafari ◽  
Amin Sedokani
Keyword(s):  
Clinical Trial ◽  
Helicobacter Pylori ◽  
Standard Treatment ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
P Value ◽  
Bismuth Subcitrate ◽  
Significant Difference ◽  
H Pylori

AbstractBackgroundConsidering the increase in drug resistance over time to Helicobacter pylori treatment relying on the anti-inflammatory and antibacterial effects of atorvastatin to increase the success rate of H. pylori eradication, we examined the effect of adding atorvastatin to standard treatment of H. pylori eradication.Materials and MethodsA total of 186 symptomatic patients who had been diagnosed with Helicobacter pylori infection and tested for H. pylori eradication were examined by a pathological response or positive urea breath test. Patients who received atorvastatin in addition to standard treatment were also identified based on a table of random numbers. Standard treatment included a 240mg bismuth subcitrate tablet, a 40mg pantoprazole tablet, a 500mg metronidazole tablet, and 2 capsules of 500mg amoxicillin, all taken BID for 14 days. After 4 weeks of treatment, all patients underwent stool testing for H. pylori fecal antigen. If the test was positive, the request was considered a failure of treatment, and if the test was negative, it was considered a successful eradication of H. pylori. The clinical trial registration code for this study is IRCT20190823044589N1.ResultsThe eradication rate of H. pylori was 80% in the control group and 80.9% in the intervention group, which did not show a statistically significant difference between the two groups (P-value = 0.971).ConclusionAdding atorvastatin to 4-drug regimen of PPI, bismuth subcitrate, amoxicillin, and metronidazole as the first line of treatment for H. pylori eradication is ineffective.

The evaluation of nasal mucociliary clearance in patients with Helicobacter pylori infection

2019 ◽  
Vol 133 (03) ◽  
pp. 220-223
Author(s):  
S Üstün Bezgin ◽  
T Çakabay ◽  
K Irak ◽  
M Koçyiğit ◽  
B Serin Keskineğe ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Mucociliary Clearance ◽  
Endoscopic Examination ◽  
Control Group ◽  
Clearance Time ◽  
Saccharine Test ◽  
Significant Difference ◽  
And Gender ◽  
H Pylori ◽  
Nasal Mucociliary Clearance

AbstractObjectiveThis study aimed to examine nasal mucociliary clearance time in patients with Helicobacter pylori infection.MethodsFifty patients who were newly diagnosed with H pylori infection using gastric biopsy in the gastroenterology out-patient clinic, and 50 age- and gender-matched healthy adults who were admitted to the otorhinolaryngology out-patient clinic, were included in this study. After an otorhinolaryngological examination (anterior rhinoscopy and nasal endoscopic examination), the nasal mucociliary clearance time of each subject was calculated using the saccharine test.ResultsThe mean mucociliary clearance time was 06:29 ± 3:31 minutes (range, 00:55–15:19 minutes) in the control group and 10:12 ± 06:09 minutes (range, 01:28–32:00 minutes) in the study group. Comparisons of the two groups revealed a statistically significant difference (p = 0.002).ConclusionNasal mucociliary clearance time was significantly increased in patients with H pylori infection. The results suggest that H pylori infection may have an unfavourable effect on nasal mucociliary clearance.

scholarly journals A Retrospective Experience of Helicobacter pylori Histology in a Large Sample of Subjects in Northern Italy

Life ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. 650
Author(s):  
Davide Giuseppe Ribaldone ◽  
Carlo Zurlo ◽  
Sharmila Fagoonee ◽  
Chiara Rosso ◽  
Angelo Armandi ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Large Population ◽  
Population Data ◽  
Signet Ring Cell ◽  
Current Data ◽  
Low Grade ◽  
Gastric Cardia Adenocarcinoma ◽  
Significant Difference ◽  
H Pylori ◽  
The Impact

Updated data about the prevalence of Helicobacter pylori (H. pylori) and its correlation with histological results are scarce. The aim of our study was to provide current data on the impact of H. pylori in a third-level endoscopy service. We performed a large, retrospective study analyzing the results of all histological samples of gastroscopy from the year 2019. In total, 1512 subjects were included. The prevalence of H. pylori was 16.8%. A significant difference between the prevalence in subjects born in Italy and those from eastern Europe, south America, or Africa was found (p < 0.0001, p = 0.006, and p = 0.0006, respectively). An association was found between H. pylori and active superficial gastritis (p < 0.0001). Current H. pylori and/or a previous finding of H. pylori was related to antral atrophy (p < 0.0001). Fifteen patients had low-grade dysplasia. There were no statistically significant associations with current or past H. pylori infection. One patient presented gastric cardia adenocarcinoma with regular gastric mucosa. One patient, H. pylori positive, was diagnosed with gastric signet ring cell adenocarcinoma in a setting of diffuse atrophy, without metaplasia.. Our study provides updated, solid (biopsy diagnosis and large population) data on the prevalence of H. pylori infection in a representative region of southern Europe.

scholarly journals Comparing the efficacy and side-effects of PDLASTA® (Pegfilgrastim) with PDGRASTIM® (Filgrastim) in breast cancer patients: a non-inferiority randomized clinical trial

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Safa Najafi ◽  
Maryam Ansari ◽  
Vahid Kaveh ◽  
Shahpar Haghighat
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Single Dose ◽  
Side Effects ◽  
Randomized Clinical Trial ◽  
Cancer Patients ◽  
Injection Site Reaction ◽  
Study Groups ◽  
Breast Cancer Patients ◽  
Significant Difference

Abstract Background The objective of this study was to compare the efficacy and side effects of a single dose (Pegfilgrastim or PDL) or repeated six daily injections (Filgrastim or PDG) during chemotherapy courses in breast cancer patients in a non-inferiority clinical trial. Methods In this randomized clinical trial, 80 patients were recruited and allocated randomly to two equal arms. In one group, a single subcutaneous dose of PDL was injected the day after receiving the chemotherapy regimen in each cycle. The second arm received a subcutaneous injection of PDG for six consecutive days in each cycle of treatment. The side effects of GCF treatment and its effect on blood parameters were compared in each cycle and during eight cycles of chemotherapy. Results Hematologic parameters showed no significant differences in any of the treatment courses between the two study groups. The comparison of WBC (p = 0.527), Hgb (p = 0.075), Platelet (p = 0.819), Neutrophil (p = 0.575), Lymphocyte (p = 705) and ANC (p = 0.675) changes during the eight courses of treatment also revealed no statistically significant difference between the two study groups. Side effects including headache, injection site reaction and muscle pain had a lower frequency in patients receiving PDL drugs. Conclusion It seems that PDL is non-inferior in efficacy and also less toxic than PDG. Since PDL can be administered in a single dose and is also less costly, it can be regarded as a cost-effective drug for the treatment of chemotherapy-induced neutropenia. Trial registration IRCT20190504043465N1, May 2019.

Complications and surgical results of stone-directed antegrade pyelography compared to the retrograde pyelographic access method in percutaneous nephrolithotomy using ‘bull’s eye’ technique: A randomized clinical trial

2021 ◽  
pp. 205141582199372
Author(s):  
Dariush Irani ◽  
Abdolreza Haghpanah ◽  
Mohammad Mehdi Hosseini ◽  
Leila Malekmakan ◽  
Mohammad Ali Ashraf ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Percutaneous Nephrolithotomy ◽  
Renal Stones ◽  
Surgical Results ◽  
Retrograde Pyelography ◽  
Antegrade Approach ◽  
Antegrade Pyelography ◽  
Significant Difference ◽  
Bull's Eye

Objectives: This study aimed to evaluate the differences in outcomes and complications in stone-directed antegrade pyelography using the ‘bull’s eye’ technique in patients with renal stones versus the conventional method of percutaneous nephrolithotomy (PCNL). Although conventional PCNL access using retrograde pyelography is useful, it is time-consuming and may cause postoperative discomfort. Herein, we report our experience in the application of this new technique. Methods: Between January 2017 and June 2018, 100 patients participated in this randomized clinical trial. Stone-directed antegrade pyelography using the ‘bull’s eye’ technique under fluoroscopic guidance was used for percutaneous access in the intervention group. The second group, consisting of those who had undergone conventional PCNL using retrograde pyelography and ‘bull’s eye’ technique in the same period, were considered as the controls. Pre- and postoperative laboratory examinations, surgical results and complications were recorded and compared between the two groups. Results: A single calyceal puncture in partial staghorn and staghorn stone patients was sufficient in 72.2% of the antegrade group and in 78.9% of the retrograde group ( p=0.69). The double-puncture technique was necessary for 71.9% of renal pelvis stones in the antegrade group and for 9.4% in the retrograde group ( p<0.001). The antegrade approach reduced the mean operative time and analgesic requirement significantly ( p<0.001). No statistically significant difference, however, was found between the two groups regarding stone migration to the ureter, radiation time and postoperative complications. Conclusions: The stone-directed antegrade approach using the ‘bull’s eye’ technique is a safe and accurate method in PCNL access in patients with radiopaque and semi-opaque renal stones.

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