Evaluating the effects of adding the probiotic Balance® compared with placebo to quadruple therapy on eradication of helicobacter pylori and symptoms of patients with peptic ulcer disease referring to gastroenterology clinics in Isfahan
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
研究概览
简要总结
BACKGROUND:
Evidence has shown benefits of single-strain probiotics for Helicobacter pylori eradication. We investigated the effects of adding a multistrain probiotic compound on bismuth-containing quadruple therapy for H. pylori infection.
MATERIALS AND METHODS:
Adult patients with peptic ulcer disease and confirmed H. pylori infection (n = 180) were randomized to receive bismuth-containing quadruple therapy (omeprazole, bismuth subcitrate, amoxicillin, and clarithromycin) plus a probiotic compound or placebo for 2 weeks. The probiotic compound contained seven bacterial species including Lactobacillus and Bifidobacterium strains and Streptococcus thermophiles. Eradication of H. pylori was assessed 4 weeks after medication by (13) C urea breath test. Other outcomes were dyspepsia symptoms, therapy-related adverse effects, and patient's tolerance.
RESULTS:
Eighty-four patients in the probiotic and 86 in the placebo group completed the trial. With per-protocol (intention to treat) analysis, H. pylori was eradicated in 82.1% (76.6%) of the probiotic and 84.8% (81.1%) of the placebo group, p = .392 (0.292). Symptoms were significantly improved with similar trends in both groups. Regarding the adverse effects, diarrhea was less frequent (2.2 vs 11.1%, p = .016), while abdominal pain was more frequent (10 vs 2.2%, p = .029) in the probiotic group. The two groups were similar in treatment tolerance (p = .851).
CONCLUSIONS:
In overall, our studied multistrain probiotic compound has not beneficial effects in the treatment of H. pylori infection. It might be related to the low dosage of our probiotic regimen and/or high frequency of upper gastrointestinal adverse effects which in turn could decrease the eradication efficacy.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65 years（—）
- 性别
- All
入选标准
- •- Age 18 to 65 years,
- •- Having peptic ulcer disease on upper gastrointestinal endoscopy,
- •- Having helicobacter pylori infection diagnosed by rapid urease test or urea breath test,
- •- Willingness to participate in the study,
- •- Not having Zollinger Ellison Syndrome, cancers of the digestive tract, liver or kidney diseases, other infections may require antibiotics, immune deficiency disease,
- •- No history of upper gastrointestinal surgery,
- •- No history of the eradication of Helicobacter pylori, or the use of Proton Pomp Inhibitors, antibiotics, and probiotics (synthetic or natural) over the past 4 weeks,
- •- No contraindications for using any dug of the quadruple therapy.
- •Exclusion criteria:
- •- Not taking medications regularly, (not taking >= 20% of all the prescribed capsules),
- •- Severe side effects of the quadruple therapy.
排除标准
- 未提供