Introduction

Both the effectiveness and tolerability of Helicobacter pylori (H.p.) eradication therapy regimens are important in the management of H.p. infection, since the presence of side effects significantly reduces compliance between the doctor and the patient and sometimes can lead to treatment interruption. Our study aimed to compare the efficacy and tolerability of eradication therapy depending on the addition of Saccharomyces boulardii or a synbiotic complex.

Aims & Methods

The study included 78 patients (54 women and 24 men) with confirmed H.p. infection using validated tests, without previous eradication in the anamnesis. All patients underwent a course of eradication therapy, which included proton pump inhibitor (PPI) + amoxicillin (A) + clarithromycin (C) + bismuth subcitrate (B). Patients were divided into 2 groups: in group A (37 patients, 25 women, 12 men, mean age 44±3.2 years) S. boulardii CNCM I-745 was added to the mentioned regimen. In group B (41 patients, 29 women, 12 men, mean age 47±2.8 years), a synbiotic complex containing strains of probiotic bacteria Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus delbrueckii subsp. bulgaricus, Lactobacillus fermentum, Lactobacillus rhamnosus, Lactobacillus casei subsp. сasei, Streptococcus thermophilus, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium adolescentis, Propionibacterium freudenreichii subsp. Shermanii, prebiotics inulin and lactulose were added to the indicated regimen. The duration of eradication therapy was 10 days. The duration of taking the probiotic and synbiotic complex ‒ 15 days.

Results

In group A, the effectiveness of the PPI+A+C+B regimen with the addition of S. boulardii was 75.7%. In group B (with the addition of a synbiotic) - 87.8%. We compared the tolerability of the indicated regimens. In no case (in both groups) was the treatment interrupted due to the presence of serious side effects. In total, 20 (54.1%) patients from group A and 17 patients (41.5%) from group B reported non-serious adverse events, including nausea (group A ‒ 8 patients (21.6%), group B ‒ 6 (14.6%), bitter taste in the mouth (group A ‒ 16 patients (43.2%), group B ‒ 15 (36.6%), and diarrhoea (group A ‒ 6 patients (16.2%), group B ‒ 0 (0%). No other adverse events were documented. Comparing gastrointestinal symptoms using the Gastrointestinal Symptom Rating Scale (GSRS) showed that in group A, mean values of the total score before treatment were 35.9±3.14 points, vs 26.2±1.64 points 20 days after the eradication course (p<0.05). In group B 34.1±2.44 points before treatment, vs 21.7±1.98 points 20 days after the eradication course (p<0.05). Comparing the total score of the GSRS questionnaire after treatment between groups A and B also showed a significant difference: 26.2±1.64 points in group A vs 21.7±1.98 points in group B (p<0.05).

Conclusion

Our study revealed better efficacy (87.8%) of the eradication regimen PPI+A+C+B with the addition of a synbiotic compared to the similar regimen with the addition of Saccharomyces boulardii (75.7%) in patients from Vinnytsia region, Ukraine. In addition, it was found that when the synbiotic complex was added, side effects of eradication therapy were noted in a smaller percentage of patients and significantly (p<0.05) lower values of the total score of the GSRS questionnaire were noted 20 days after treatment, in contrast to the regimen with the addition of Saccharomyces boulardii.

Introduction

Recents meta-analyses have shown that Tegoprazan (Tego) could be equal or superior to proton pump inhibitors in the eradication of Helicobacter pylori (HP). However, virtually all primary studies have been conducted in Asian populations, so validation in other regions is required.

Aims & Methods

Aim: To assess the efficacy and safety of Tego compared to Esomeprazole (Eso) in Latin population. Methods: We studied 117 consecutive treatment-naive HP infected patients [51.04±12.11 (48.85-53.24) years, 75% females] evidenced by endoscopic biopsy. Patients were randomized to receive either Tego (50 mg) or Eso (40 mg), both in combination with Amoxicillin (1 g) and Clarithromycin (500 mg), all administered twice daily for 14 days. Treatment efficacy was assessed using a urea breath test performed 35±2 days post-therapy. Treatment safety was monitored by recording adverse events. Additionally, dyspeptic symptoms, general laboratories and quality of life (SF-36 questionnaire) were assessed. Data expressed mean±SD and 95% CI or percentages, while statistical differences were evaluated with the unpaired and paired Student t test or the chi-square test, as appropriate. Alpha = 0.05.

Results

There were no differences between Tego and Eso groups in age [51±12.14 (47.79-54.21) vs. 51.08±12.28 (48.02-54.14) years respectively, p= 0.97] or sex (75.4% vs. 74.6% women respectively, p=0.76). Tego and Eso groups showed similar efficacy (94.55% vs 93.55% respectively, p=0.82) and adverse events (14.55% vs 22.58% respectively, p=0.26). Main symptoms in Tego group were diarrhea (n=4) and headache (n=2) meanwhile Eso group referred diarrhea (n=4) and abdominal pain (n=4). All adverse events were mild and suspend treatment was not required. Dyspeptic symptoms decreased after treatment in both Tego (78.88% vs 45.45%, p=0.0004) and Eso (79.03% vs 46.77%, p=0.0002) groups but there were no differences before (p=0.9108) and after (p=0.8864) treatment between them. There were no differences in the 18 components of the general laboratories (all in normal range) between groups before and after treatment. Physical component summary (CS) improved post treatment in both Tego [48.56±13.96 (44.87-52.25) vs 51.83±13.17 (48.35-55.31), p=0.03] and Eso [46.95±11.35 (44.13-49.78) vs 52.29±13.22 (49-55.58), p=0.01] groups. Mental CS showed no differences after treatment en Tego [47.35±5.99 (45.77-48.94) vs 47.8±6.48 (46.09-49.51), p=0.62] nor Eso [47.51±6.67 (45.86-49.17) vs 47.82±5.39 (46.47-49.16), p=0.78] groups. There was no difference in physical or mental CS between Tego and Eso groups before (p=0.49 and p=0.85, respectively) or post treatment (p=0.89 and p=0.98, respectively) Table 1.

Table 1. The 8 domains of SF-36 in both groups (*p<0.05 vs basal)

Conclusion

Our work shows that Tegoprazan is equally effective and safe as Esomeprazole for triple therapy to eradicate Helicobacter pylori in Latin population. We also found that eradication treatment improves general health, physical functioning, and physical component summary, which warrants further investigation. Clinical Trials registration: NCT06318104.

References

(/10.1080/14787210.2025.2459722) (10.1002/jgh3.70134)

Disclosure

We would like to thank Carnot Laboratories for providing tegoprazan for this study.

Introduction

Endoscopic ampullectomy is a minimally invasive technique for treating non-invasive ampullary lesions and in patients who are poor surgical candidates. Compared to surgical approaches, endoscopic ampullectomy have lower morbidity and mortality rates.

Aims & Methods

The aim of this study was to describe the safety and outcome of this procedure from a single tertiary center experience.A retrospective study conducted on patients with non-invasive ampullary lesions. Data were collected from our database and parameters related to ampullectomy outcome and complications were retrospectively analyzed. EUS evaluation of the stage and intraductal extension was performed in all patients. Snare sizes between 20 to 30 mm were used in these patients. Electrosurgical unit setting ENDOCUT Q effect 2 was used for resection. All patients were given indomethacin suppositories. Submucosal injection was performed only where the ampullary lesions extend to the duodenal mucosa.

Results

From 2015 to 2024, a total of 15 patients were included in the study. There was 9 males and 6 females. Their median age was 56 years (55-75). Lesions range from 20 to 50 mm in size, with average size of 25 mm. Prophylactic pancreatic duct stenting was performed in all cases of which none developed pancreatitis. Biliary stenting was performed in 3 cases (20%) with cholangitis. Submucosal injection was performed in 2 lesions with extension to the duodenal mucosa. Post resection histology showed adenoma with low grade dysplasia in 9 patients (60%), adenoma with high grade dysplasia in 2 patients (13.3%), adenoma with focal adenocarcinoma in 2 patients (13.3%), hyperplastic lesion indefinite for dysplasia in 1 patient (6.7%) and hamartoma in 1 patient (6.7%). Enbloc resection was achieved in 14 (93.3%), while piecemeal in 1 case (6.7%). Recurrence observed in 1 patient (6.7%) with focal adenocarcinoma. Biopsy from the recurrent growth revealed focal adenocarcinoma and patient underwent surgical resection. No recurrence was observed in the patient with piecemeal resection for 24 months of follow up. Intra-procedural bleeding occurred in 2 patients (13.2%) and managed successfully with snare tip coagulation and hemoclips, delayed melena (after 24 hours) in 1 patient (6.7%) controlled with conservative management. Only 1 of the 12 patients (8.3%) without biliary stents developed ampullary stenosis post-procedure and managed with plastic biliary stent. There was no report of perforation, need for emergency surgery or 30-days mortality in this series.

Conclusion

Endoscopic ampullectomy seems effective and safe treatment option in cases with non-invasive ampullary lesions. Careful patient selection & adherence to follow up is the best way to achieve best therapeutic outcome.