NL-OMON42735已完成不适用
Characterization Of Resistance Against Live-attenuated diarrhoeagenic E. coli - CORA
IZO food research0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
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. Ability to follow verbal and written instructions;
- •2. Age between 18 and 55 years;
- •3. Availability of internet connection;
- •4. BMI >=20 and <=27 kg/m2;
- •5. Healthy as assessed by the NIZO food research medical questionnaire;
- •6. Male subjects;
- •7. Signed informed consent;
- •8. Voluntary participation;
- •9. Willing to accept disclosure of the financial benefit of participation in the study to the authorities concerned;
- •10. Willing to accept use of all encoded data, including publication, and the confidential use and storage of all data for at least 15 years;
- •11. Willing to comply with study procedures;
- •12. Willingness to abstain from high calcium containing products.
- •13. Willingness to abstain from medications that contain acetaminophen, aspirin, ibuprofen, and other nonsteroidal anti-inflammatory drugs, (OTC) antacids and antimotility agents (eg, loperamide) on the three days before, during and 3 days after diarrhoeagenic E. coli challenge.
- •14. Willingness to abstain from alcoholic beverages three days before, during and three days after diarrhoeagenic E. coli challenge.
- •15. Willingness to give up blood donation starting 1 month prior to study start and during the entire study;
排除标准
- •1. Disease of the GI tract, liver, bile bladder, kidney, thyroid gland (self-reported);
- •2. Diarrhoeagenic E.coli strain (as used in the study) detected in fecal sample at screening;
- •3. Evidence of current excessive alcohol consumption or non-therapeutic drug (ab)use);
- •4. Evidence of IgA deficiency (serum IgA < 7 mg/dL or below the limit of detection of assay).
- •5. High titer serum antibodies against CFA-II diarrhoeagenic E.coli strain (as used in the study) at screening;
- •6. History of microbiologically confirmed ETEC or cholera infection in last 3 years.
- •7. Known allergy to the following antibiotics: ciprofloxacin, trimethoprim-sulfamethoxazole, and penicillins.
- •8. Mental status that is incompatible with the proper conduct of the study;
- •9. Not having a general practitioner, not allowing disclosure of participation to the general practitioner or not allow to inform the general practitioner about abnormal results.
- •10. Occupation involving handling of ETEC or Vibrio cholerae currently, or in the past 3 years.
- •11. Participation in any clinical trial including blood sampling and/or administration of substances starting 1 month prior to study start and during the entire study;
- •12. Personnel of NIZO food research, their partner and their first and second degree relatives;
- •13. Reported average stool frequency of <1 or >3 per day;
- •14. Symptoms consistent with Travelers' Diarrhoea concurrent with travel to countries where ETEC infection is endemic (most of the developing world) within 3 years prior to dosing, OR planned travel to endemic countries during the length of the study.
- •15. Use of antibiotics, norit, laxatives (up till 6 months prior to inclusion), cholestyramine, antacids, H2 receptor antagonists or proton pump inhibitors or immune suppressive agents (up till 3 months prior to inclusion);
- •16. Vaccination for or ingestion of ETEC, cholera, or E coli heat labile toxin within 3 years prior to inclusion;
- •17. Vegetarians and vegans
研究者
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