TCTR20200714004尚未招募3 期
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
allemand Health Solutions0 个研究点目标入组 100 人开始时间: 2020年7月14日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
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
- •- 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.
研究者
相似试验
已完成
3 期
The efficacy and safety of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetes; A 52-week randomised, treat-to-target, placebo-controlled, double-blinded, parallelgroup, multinational, multi-centre trial10018424diabetesNL-OMON38605ovo Nordisk50
进行中（未招募）
1 期
The efficacy and safety of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetesMedDRA version: 16.0Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861Diabetes Mellitus, Type 1EUCTR2012-003580-21-NOovo Nordisk A/S1,398
进行中（未招募）
1 期
The efficacy and safety of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetesMedDRA version: 16.0Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861Diabetes Mellitus, Type 1EUCTR2012-003580-21-BEovo Nordisk A/S1,398
进行中（未招募）
不适用
The efficacy and safety of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetesMedDRA version: 16.1Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861Diabetes Mellitus, Type 1EUCTR2012-003580-21-SEovo Nordisk A/S1,404
进行中（未招募）
不适用
The efficacy and safety of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetesMedDRA version: 18.0Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861Diabetes Mellitus, Type 1EUCTR2012-003580-21-PLovo Nordisk A/S1,404