DRKS00027126招募中不适用
A study to evaluate the optimal dose of FenuLife® (water soluble fiber) for assessment of its effect on occasional burning sensation and associated complaints - IFF/007921
Frutarom Ltd.0 个研究点目标入组 60 人开始时间: 2022年11月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- All
入选标准
- •1. 18-60 years of age
- •2. Body Mass Index (BMI) 18.5-34.9 kg/m²
- •3. Generally healthy, as judged by the investigator at V1,
- •based on self-reported medical history and physical examination
- •4. Occasional epigastric burning sensation after meals (selfreported)
- •within at least one month prior to V1
- •5. A sufficient burning sensation intensity after the provocative
- •standardized meal at V1 (>20mm at a 100-mm visual
- •analogue scale (VAS), and lasting burning sensation until
- •the end of the hour after the meal (>15 mm on a 100-mm
- •6. Willingness to comply with the study requirements, in particular:
- •- consume the provocative meal at visits
- •- complete the study assessments at visits
- •7. Willingness not to change dietary habits (no start/change
- •of diet) and general life-style (e.g. level of physical activity)
- •during study duration
- •8. Willingness not to use antacids or any products against
- •burning sensation in the 12 hours prior to and during any
- •9. Willingness not to use proton-pump inhibitors, H2 receptor
- •antagonists (H2RA) or any products against epigastric
- •burning sensation (besides antacids) during the study
- •10. Females of child-bearing potential: willingness to use appropriate
- •contraception methods during the study; negative
- •pregnancy testing (beta human chorionic gonadotropin test in urine) at V1
排除标准
- •1. Self-reported known allergies or hypersensitivity to any of
- •the test components or the standardized provocative meal
- •2. Self-reported known diseases that may indirectly affect digestion,
- •confound study results or interfere with compliance, as per investigator’s judgment (e.g. diabetes,
- •biliary tract disease, ulcer, irritable bowel disease)
- •3. Self-reported known diagnosis of gastroesophageal reflux
- •disease (GERD)
- •4. Involuntary loss of weight within 3 months prior to V1
- •5. History of foregut surgery
- •6. Smoking
- •7. Regular use of treatment that may indirectly affect digestion,
- •confound study results or interfere with compliance,
- •as per investigator’s judgment (e.g. antibiotics, osteoporosis
- •drugs, non-steroidal anti-inflammatory drugs, prokinetics)
- •8. Use of any dietary supplements for reducing burning sensation
- •/natural fibres additives within 1 month prior to V1
- •9. Use of any products against epigastric burning sensation
- •(except antacids) within 2 weeks prior to V1
- •10. Females who are pregnant or breast-feeding
- •11. Abuse of drugs, alcohol or medication within 6 months
- •prior to V1 and/or during the study
- •12. Participation in any clinical trial within 3 months prior to V1
- •or during the study
- •13. Other reasons judged by the investigator to render the
- •subject unsuitable for the study
研究者
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