Randomized, Double-blind, Placebo-controlled Clinical Study to Assess the Adjuvant Role of Dietary Supplementation of Antibiotic-tolerant Probiotics in Standard Therapy for the Eradication of Helicobacter Pylori Infection.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- EACTE (Adverse Events Correlated to Eradication Therapy) incidence
研究概览
简要总结
Randomized, double-blind, placebo-controlled clinical study to assess the adjuvant role of dietary supplementation of antibiotic-tolerant probiotics, derived from Lactobacillus acidophilus and Bifidobacterium animalis, in standard therapy for the eradication of Helicobacter pylori infection.
详细描述
Randomized, double-blind, placebo-controlled clinical study to assess the adjuvant role of dietary supplementation of antibiotic-tolerant probiotics, in standard therapy for the eradication of H. pylori infection.
The aim of this study is to evaluate the antibiotic adverse events decrease in subjects under the standard therapy for H. Pylori eradication using probiotics, compared to patients receiving the same antibiotic therapy with placebo.
This study is aimed to (naive) patients who have never received the eradication therapy.
The infection of H. Pylori will be analyzed using Urea Breath Test, esophagogastroduodenoscopy (EGDS), Histological and/or culture examination on biopsy samples.
The incidence and severity of the adverse events related to the eradication therapy will be assessed through the evaluation questionnaire EACTE (Eventi Avversi Correlati con la Terapia Eradicante) - Adverse Events correlated to Eradication Therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of H. pylori infection by breath test and histological and/or cultural examination on biopsy (performed within 10 days prior to T0)
- •Prescription of eradication therapy for HP
- •Naïve patients (who have never had eradication therapy for H. pylori)
- •Patients with symptoms of upper gastrointestinal tract
- •Obtaining informed consent
排除标准
- •Patients with history of previous eradication attempts
- •Patients with known gastric disease (e.g. atrophic gastritis, gastric cancer)
- •Patients with severe organ dysfunction (cirrhosis of the liver, severe renal or respiratory failure, dialysis)
- •Women who are pregnant or breastfeeding
- •Patients unable to provide informed consent
结局指标
主要结局
EACTE (Adverse Events Correlated to Eradication Therapy) incidence
时间窗: T0 (basal) - T1 (20 ± 3 days after T0)
Assessment of the incidence of "Adverse events related to eradication therapy" regardless of the degree of severity, in the group taking the dietary supplement with probiotic, compared to the group taking placebo. The adverse events related to eradication therapy are those described by the EACTE Assessment Questionnaire used
次要结局
- Eradication rate of H. pylori(T2 (48 ± 3 days after T0))
- EACTE severity(T0 (basal) - T2 (48 ± 3 days after T0))
- Severe EACTE(T0 (basal) - T1 (20 ± 3 days after T0))
- GSRS (Gastrointestinal Symptom Rating Scale) score(T2 (48 ± 3 days after T0))