NL-OMON34362已完成不适用
The safety and gastro-intestinal tolerance of recombinant human lactoferrin (rhLF) in apparently healthy human volunteers - Safety and gastro-intestinal tolerance of rhLF
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
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 至 99（—）
入选标准
- •1. Healthy as assessed by the
- •- TNO health and lifestyle questionnaire, (P8896 F02; in Dutch)
- •- results of the pre-study safety laboratory tests
- •2. Volunteers aged > 25 and < 50 years at Day 01 of the study (gender distribution ideally 50%-50%, must not exceed 40%-60%)
- •3. Body Mass Index (BMI) 18-28 kg/m2
- •4. Regular and normal Dutch eating habits as assessed by P8896 F02
- •5. Voluntary participation
- •6. Having given written informed consent
- •7. Willing to comply with the study procedures
- •8. Willing to accept use of all encoded data, including publication, and the confidential use and storage of all data for at least 15 years
- •9. Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned.
排除标准
- •1. Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
- •2. Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances
- •3. Having a history of medical or surgical events that may significantly affect the study outcome
- •4. Frequent and/or intense sports practice (more than 10 hours/week)
- •5. Smoking
- •6. Alcohol consumption > 21 units/week for males and > 14 units/week for females.
- •7. Any history of any allergy, sensitivity or anaphylaxis, especially if related (but not limited) to food products (e.g. chocolate, wheat, dairy products, or milk-derived products, egg, nuts, etc.) and seasonal allergy (e.g. hay fever)
- •8. Current or intermittent gastro-intestinal complaints (stomach upsets, diarrhoea, constipation, flatulence, abdominal colic, etc.), or any known gastro-intestinal disorder (e.g. ulcerative colitis, Crohn*s disease)
- •9. Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening
- •10. Use of antibiotics or laxatives within 1 month before day 01 of the study
- •11. Reported slimming or medically prescribed diet
- •12. Reported vegan, vegetarian or macrobiotic
- •13. Pregnant or lactating female or wishing to become pregnant in the period of the study
- •14. Females not using acceptable contraception
- •15. Recent blood donation (<1 month prior to the start of the study)
- •16. Not willing to give up blood donation during the study.
- •17. Personnel of TNO Quality of Life location Zeist, their partner and their first and second degree relatives
- •18. Not having a general practitioner
- •19. Not willing to accept information-transfer concerning participation in the study, or information regarding his/her health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner.
研究者
相似试验
已完成
不适用
Evaluation of gastrointestinal tolerance of a new thickening powder in patients with dysphagiaDysphagiaSigns and SymptomsISRCTN86521801umico Research BV (Netherlands)50
已完成
2 期
Confirmation of safety of new gastrointestinal peptide Ghrelin in patients with chronic kidney diseaseChronic kidney diseaseJPRN-UMIN000021580Division of Nephrology, Endocrinology and Metabolism School of Medicine Keio University6
进行中（未招募）
不适用
Micro-biological and clinical evaluation of the results after adjuvanter laser therapy with 810nm diode laser in frame the parodontologic basis therapyParadontosisEUCTR2009-015888-14-ATFa.Elexxion
已完成
不适用
Evaluation of the efficacy for gastrointestinal condition and safety of boiled rice with higher resistant starch content.JPRN-UMIN000028791iigata Bio-Research Park, Inc30
招募中
不适用
Safety and usefulness of Roux-en Y gastro-jejunostomy with peroral endoscopy after distal gastrectomyGastric cancerJPRN-UMIN000010173Digestive Disease Center, Showa University Koto Toyosu Hospital300