A Prospective Open-label Study on Efficacy and Tolerability of Colloidal Bismuth Sub-citrate as Adjunctive Therapy to a Combination of Esomeprazole, Amoxicillin and Metronidazole for 10 Days for Helicobacter Pylori Elimination in Children
试验速览
- 阶段
- 4 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 13C-urea breath test
研究概览
简要总结
Helicobacter pylori infection causes chronic gastritis, peptic ulcer disease and is involved in the development of gastric cancer.
Current accepted strategies to eliminate the infection in children are a 10 days sequential treatment (proton pump inhibitor + amoxicillin 5 days followed by proton pump inhibitor + metronidazole + clarithromycin 5 days) or a triple therapy 14 days (proton pump inhibitor + amoxicillin + clarithromycin or metronidazole).
However, there is a concern due to the growing resistance of Helicobacter pylori strains to antibiotics, especially clarithromycin, and the decreased efficacy of first line treatment regimens to satisfactorily eliminate the infection in children.
Recent data show that combinations using bismuth salts must be considered in adults. Indeed, the efficacy of a 10 days of quadruple therapy with omeprazole plus a single three-in-one capsule containing bismuth subcitrate, metronidazole and tetracycline was shown to be highly superior to the standard triple therapy combining omeprazole, amoxicillin, and clarithromycin without related severe adverse events.
The possibility of re-using bismuth salts on a more regular basis in pediatrics is being restudied through a monocentric, prospective, open label, single arm clinical trial to assess the safety and efficacy of a 10 days colloidal bismuth sub-citrate as an adjunctive therapy in combination with esomeprazole, amoxicillin and metronidazole in children aged 6-17 years, infected by Helicobacter pylori.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paediatric subjects aged 6 to 17 years of either gender
- •Body weight ≥ 20kg.
- •Helicobacter pylori gastritis confirmed by positive histology and culture with antimicrobial susceptibility testing.
- •Antral and corpus biopsies must have been taken for histology and culture during an upper GI endoscopy performed for chronic or recurrent pain in the epigastric region with epigastric tenderness at physical examination.
- •Subject able to swallow tablets.
- •All girls of child-bearing potential must have a negative urine pregnancy test at Visit
- •If sexually active, girls of child-bearing potential and boys whose partner is of child-bearing potential agree to use highly effective method of birth control during the trial.
- •In the Investigator's opinion, patient is willing and able to comply with all trial requirements specified in this protocol.
- •Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.
- •Subjects (or their legally-acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Assent is also required of children capable of understanding the nature of the study (typically older than 11 years of age).
排除标准
- •Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
- •Have a history of significant renal or hepatic impairment.
- •Have an erosive esophagitis or peptic ulcer disease in the gastric or the duodenal mucosa showed during the upper GI endoscopy.
- •Have received proton pump inhibitors within 2 weeks prior to first administration of study agent.
- •Have received any antimicrobial agent within 4 weeks prior to first administration of study agent.
- •Require routine use (≥ 2 times per week) of non-steroidal anti-inflammatory drug (NSAID).
- •Are under any immunosuppressive agent.
- •Are under oral or IV steroids
- •Have a scheduled elective surgery or any procedures requiring general anaesthesia during the trial.
- •Have known allergies or a known hypersensitivity to any Study Drugs or their excipients (refer to Study Drugs SmPCs).
- •Contraindication for any of the Study Drugs (refer to Study Drugs SmPCs).
- •Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements.
- •Subjects who are participating or have participated in another study with an IMP in the past 12 weeks.
研究组 & 干预措施
Treatment arm
干预措施: colloidal bismuth sub-citrate (Drug)
结局指标
主要结局
13C-urea breath test
时间窗: Week 10
Ratio of 13C/12C, expressed as delta 13C in pro mil, and compared with PeeDee Belemnite calcium carbonate standard
次要结局
- Intestinal microbiome analysis(Week 10)
- Incidence of treatment-emergent adverse event(Up to 10 weeks after start of study treatment)
- Adherence to the study treatment(week 2)
- Effect of antimicrobial resistance on the success rate(Week 10)