NL-OMON48558已完成不适用
GIGA Study: Gastrointestinal benefit of dairy Ingredients to prevent symptoms of Gut infection in healthy Adult subjects - GIGA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
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
- •2. Age between 18 and 55 years.
- •3. BMI *18.5 and *30.0 kg/m2.
- •4. Healthy as assessed by the NIZO food research medical questionnaire.
排除标准
- •1. Acute gastroenteritis in the 2 months prior to inclusion.
- •2. Any confirmed or suspected immunosuppressive or immunodeficient condition including human immunodeficiency virus infection (HIV).
- •3. Disease of the GI tract, liver, bile bladder, kidney, thyroid gland (self-reported), except for appendicitis.
- •4. History of microbiologically confirmed ETEC or cholera infection within 3 years prior to inclusion.
- •5. Symptoms consistent with Travelers' Diarrhea concurrent with travel to countries where ETEC infection is endemic (most of the developing world) within 3 years prior to inclusion, OR planned travel to endemic countries during the length of the study.
- •6. Vaccination for, or ingestion of cholera within 3 years prior to inclusion, including studies at NIZO.
- •7. Occupation involving handling of ETEC or Vibrio cholerae currently, or within 3 years prior to inclusion.
- •8. Vaccination for, or ingestion of ETEC or E coli heat labile toxin, including E. coli challenge studies at NIZO.
- •9. Evidence of current excessive alcohol consumption (>4 consumptions/day or >20 consumptions/week) or drug (ab)use, and not willing/able to stop this during the study.
- •10. Known allergy to the following antibiotics: ciprofloxacin, trimethoprim, sulfamethoxazole, and penicillins.
- •11. Reported average stool frequency of >3 per day or <1 per 2 days.
- •12. Use of antibiotics (up till 6 months prior to inclusion), norit, laxatives, cholestyramine, antacids H2 receptor antagonists or proton pump inhibitors (during 3 months prior to inclusion).
- •13. Use of immunosuppressive drugs (e.g. cyclosporine, azathioprine, systemic corticosteroids, antibodies).
- •14. Vegans.
- •15. Mental status that is incompatible with the proper conduct of the study.
- •16. A self-reported milk allergy, lactose intolerance or sensitivity to dairy ingredients.;For the subgroup of participants for exhaled breath analysis, the following additional exclusion criterion applies for participation in the VOC feasibility analysis:
- •History of or current self-reported or doctor-diagnosed disease of the lungs, such as asthma or COPD.
研究者
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