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临床试验/NCT05399862
NCT05399862已完成不适用

The Effect of Lactobacillus Reuteri Probiotic as an Adjunct Treatment for Helicobacter Pylori Infection in Adults

Universiti Kebangsaan Malaysia Medical Centre2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年12月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
2
主要终点
The eradication rate of Helicobacter pylori infection

研究概览

简要总结

This is a prospective, randomised, double-blind, placebo-controlled trial involving newly diagnosed Helicobacter pylori (H. pylori) patients. Patients will be prescribed with standard triple therapy for 2 weeks and supplemented with either probiotic (Lactobacillus reuteri DSM 17648) or placebo for 4 weeks. In this study, we are investigating the effect of Lactobacillus reuteri in H. pylori eradication; mainly in improving eradication rate, ameliorating gastrointestinal symptoms and reducing adverse effects of antibiotics. We hypothesised that in H. pylori patients receiving Lactobacillus reuteri as adjunct treatment, there will be an improvement in H. pylori eradication rate as well as reduction of gastrointestinal symptoms and treatment adverse effects.

详细描述

The prime discovery of Helicobacter pylori (H. pylori) in chronic gastritis patients by Marshall and Warren in 1982 has geared a frenetic pace in H. pylori research. H. pylori is a helix-shaped microaerophilic gram negative bacterium colonising gastric epithelium leading to disruption of protective mucosal layer by inflammatory process and gastric acid secretion.

H. pylori remains as one of the commonest bacterial pathogens causing chronic infection in the adult population with at least 50% of the global population being infected. The prevalence is even higher in developing countries with up to 80% of them being affected. Although some of the patients with H. pylori infection are asymptomatic, 10-20% of them may progress into H. pylori associated disease such as chronic gastritis, peptic ulcer disease and gastric malignancy. The clinical heterogeneity is believed to be due to different degree of virulence across different H. pylori strains.

The American College of Gastroenterology (ACG) has outlined the standard therapies of H. pylori infection, dividing them into first line and salvage therapy. Treatment regime is chosen based on previous antibiotics exposure, antibiotics allergy and resistance.[7] The eradication rate of 90% is regarded as successful in which, Kyoto Global Consensus Report recommended the similar value as a cut-off point to guide the selection of empirical treatment in each region. Clarithromycin triple therapy (clarithromycin, amoxicillin/metronidazole and proton pump inhibitor, PPI) or referred as standard triple therapy (STT) in our study is recommended as first line therapy for patients who are macrolide-naive and/or reside in low clarithromycin-resistance area. For regions with high clarithromycin resistance rate (more than 15%), ACG guideline recommends administration of bismuth quadruple, non-bismuth quadruple or concomitant therapies.

The Maastricht V/Florence Consensus report has outlined the guidelines on diagnosis and therapeutic strategies in H. pylori infection. The report highlighted failure of many countries to hit at least 80% intention-to-treat eradication rate.[9] Amongst the contributing factors are emerging antibiotics resistance, poor compliance, adverse effects of antimicrobial regime leading to poor treatment adherence, high bacterial load and impairment of gastric mucosal immunity.

Regionally, the Bangkok Consensus Report by Vilaichone et al in 2018 has studied the prevalence of H. pylori infection in nine ASEAN countries. The study demonstrated high prevalence of H. pylori in ASEAN countries ranging between 20% to 69%. Despite Malaysia having the lowest H. pylori prevalence of 20%, the eradication rates failed to meet the minimum 80% target when given STT for 7 days. Qua et al (2010) and Leow et al (2018) reported the eradication rate of 71.2% and 79.3% respectively. Extending duration of STT from seven to fourteen days illustrated marked improvement of eradication rate to 88.6% but it was still below the successful eradication target of 90%.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18-year-old and above
  • Confirmed H. pylori diagnosis
  • Informed consent to participate in the study

排除标准

  • Any active gastrointestinal disease
  • Previous surgical procedures affecting the gastrointestinal tract, e.g., bariatric surgery or gastrectomy
  • Pregnancy or breastfeeding women
  • Previous allergy to probiotics
  • Intake of proton pump inhibitor, H2 antagonist or antibiotics in the past 3 months
  • Recent diagnosis of advanced stage of malignancy
  • Recent acute gastroenteritis within 4 weeks
  • Recent history of traditional medication intake
  • Recent failure of first line eradication therapy for H. pylori

结局指标

主要结局

The eradication rate of Helicobacter pylori infection

时间窗: Urea breath test is assessed at 8 weeks post treatment

Eradication rate of H. pylori is defined as negative urea breath test result (score of less than 50 DPM)

次要结局

  • The improvement of treatment adverse effect(The treatment adverse effects were evaluated during first and second week of treatement; and further re-evaluated back at 8 weeks post treatment)
  • The improvement of H. pylori associated gastrointestinal symptoms(GSRS scores of both arms were compared between pre and 8 weeks post treatment)

研究者

发起方
Universiti Kebangsaan Malaysia Medical Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nur Izreena Ismail

Dr

Universiti Kebangsaan Malaysia Medical Centre

研究点 (2)

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