Efficacy and Safety of Lacidofil® STRONG as an Adjuvant for Helicobacter Pylori Eradication Treatment in Non-ulcer Dyspepsia: A Randomized, Placebo-controlled, Double-blind, Parallel Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Rate of H. pylori eradication
研究概览
简要总结
Treatment for H. pylori eradication includes antibiotics. The treatment has decreased its efficiency (lower capability to eradicate the infection) due to increasing antibiotic resistance in the population. But the addition of probiotics to the treatment has been observed to increase efficiency, and decreasing the antibiotics' side effects. We set to evaluate whether Lacidofil® STRONG improves efficacy when added to the standard therapy to eradicate H. pylori.
详细描述
This study aims at evaluating the efficacy of Lacidofil® STRONG as an adjuvant therapy to a standard 14-day H. pylori eradication treatment among H. pylori-positive participants with non-ulcer dyspepsia.
This is a randomized, placebo-controlled trial, with two parallel arms. Participants will be randomized to receive probiotic or placebo as adjuvant to the standard anti-H. pylori treatment. Each participant will be enrolled in the study for 12 weeks, during which they will receive the anti-H. pylori treatment and co-administration of investigational product (IP; for two weeks), followed by IP supplementation alone (for four weeks), and they will be followed-up 4 weeks after last IP administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Thai patients consulting for dyspeptic symptoms.
- •Aged between 18 and 65 years.
- •Diagnosed for H. pylori infection using RUT and 13C-UBT.
- •H. pylori treatment naïve.
- •Able to provide informed consent.
- •Willing to maintain their usual physical activity regime and diet, as well as discontinuing the consumption probiotic-containing and fermented foods.
排除标准
- •Upper gastrointestinal bleeding.
- •Presence of duodenal or gastric ulcers, MALT lymphoma, gastric resection, gastric malignancy as per endoscopy (visual assessment).
- •Current intake of antibiotics, such as amoxicillin, clarithromycin, metronidazole or fluoroquinolone.
- •Use of probiotics in the past month, and unwilling to undergo a 2-week washout period before the study.
- •Use of NSAIDs, aspirin or other anti-inflammatory drugs within 1 week (for occasional use) or 3 weeks (for chronic use) of inclusion.
- •Contraindication for gastric biopsy (e.g., coagulopathy).
- •Any history of allergy for penicillin, levofloxacin, clarithromycin or rabeprazole.
- •Receiving proton pump inhibitor within 4 weeks or receiving any antibiotics or bismuth within 2 weeks of trial initiation.
- •Being pregnant or breastfeeding.
- •Having severe underlying disease including end-stage renal disease requiring hemodialysis or peritoneal dialysis (GFR < 15), cirrhosis with Child-Pugh classification grade C, immuno-compromised host with AIDS, malignancy and/or cerebrovascular or cardiovascular disease.
- •Taking anticoagulants (e.g., warfarin) or anti-platelet agents (e.g., clopidogrel)
- •Previous gastric surgery.
- •Having underlying heart disease, including congenital long QT syndrome.
- •Unwilling to stop taking over-the-counter, natural or herbal medicines for dyspeptic or gastrointestinal symptoms (e.g., antidiarrheal, anti-emetics, antacids) during the intervention period (6 weeks).
- •Milk and soy allergy.
- •Lactose intolerance.
研究组 & 干预措施
Experimental group
These participants will receive the standard treatment for H. pylori eradication (proton-pump inhibitor and antibiotics) plus probiotic formulation (commercially-available as Lacidofil) for 12 weeks.
干预措施: Lacidofil (Dietary Supplement)
Placebo group
These participants will receive the standard treatment for H. pylori eradication (proton-pump inhibitor and antibiotics) plus placebo for 12 weeks.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Rate of H. pylori eradication
时间窗: At week 12 after treatment
Efficacy of the H. pylori eradication treatment supplemented with Lacidofil will be done by calculating the proportion of participants reaching H. pylori eradication in probiotics group compared to placebo, as per urea breath test (13C-UBT)
Rate of H. pylori eradication
时间窗: At week 6 after treatment
Efficacy of the H. pylori eradication treatment supplemented with Lacidofil will be done by calculating the proportion of participants reaching H. pylori eradication in probiotics group compared to placebo, as per urea breath test (13C-UBT)
次要结局
- Quantification of adverse events during the intervention(At week 12 after treatment)
- Efficacy: Frequency and severity of dyspeptic symptoms from baseline(At week 6 after treatment)
- Efficacy: Severity of gastrointestinal symptoms(At week 6 after treatment)
- Efficacy: Health-related quality of life (HR-QoL)(At week 6 after treatment)