ISRCTN20716052已完成未知
This multicenter, double-blind, randomized, placebo-controlled clinical evaluation is planned to determine the efficacy and safety of the use of dietary food supplements HELINORM against the background of the standard first-line eradication therapy regimen (ESO + AMO + CLA) on for 14 days followed by the use for 14 days in H. pylori-positive adult patients with functional dyspepsia
izhny Novgorod Chemical and Pharmaceutical Plant Joint Stock Company (Nizhpharm JSC)0 个研究点目标入组 172 人开始时间: 2020年1月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 172
研究概览
简要总结
2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39023173/ (added 19/07/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female aged 18 to 65
- •2. For women of childbearing potential: mandatory use of contraceptive methods
- •3. Confirmed diagnosis of functional dyspepsia according to Rome IV criteria
- •4. Presence of H. pylori infection according to 13C-UBT
- •5. Able to understand and willing to complete all protocol details
- •6. No history of previous eradication therapy at least a year before the screening
- •7. Signed informed consent
排除标准
- •1. Erosive and ulcerative changes of the gastric and/or duodenal mucosa
- •2. Cicatricial changes of the gastric and/or duodenal mucosa
- •3. History of eradication therapy less than 1 year before screening
- •4. Use of antibiotics and/or bismuth tripotassium dicitrate and/or H2-blockers and/or proton pump inhibitors 30 days before and during the trial (except for treatment according to the protocol)
- •5. Use of macrolide antibiotics less than 1 year before screening
- •6. Any severe, decompensated or unstable somatic disease that may affect the clinical evaluation of the investigational product or put the patient at risk
- •7. Alcohol or drug use
- •8. Pregnancy, lactation
- •9. Known sensitivity to any components of the investigational product and to any of the medicinal products prescribed in this trial
- •10. History of stomach surgery, small intestine resection or pancreas surgery
- •11. Positive blood test for HIV and/or syphilis and/or HbsAg and/or HCVAb
- •12. Chronic diarrhea of various etiologies, except for functional diarrhea or IBS with diarrhea
- •13. Participation in another clinical trial 30 days before and during the trial
- •14. Use of probiotics, symbiotics, prebiotics for treatment of H. pylori infections and for other reasons 30 days before the start of trial
研究者
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