NL-OMON44640已完成不适用
APA12/PANTER* study: PTM202 and modulation of host resistance to diarrheagenic Escherichia coli in a randomized placebo-controlled trial in healthy human subjects - APA12/PANTER
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
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. Age between 18 and 55 years.
- •2. BMI *18 and *27 kg/m2.
- •3. Healthy as assessed by the NIZO food research medical questionnaire.
排除标准
- •1. Any confirmed or suspected immunosuppressive or immunodeficient condition including human immunodeficiency virus infection (HIV).
- •2. Disease of the GI tract, liver, bile bladder, kidney, thyroid gland (self-reported).
- •3. Diarrheagenic E. coli strain (as used in the study) detected in fecal sample at screening.
- •4. Evidence of current excessive alcohol consumption or non-therapeutic drug (ab)use).
- •5. High titer serum antibodies against CFA-II diarrheagenic 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. Known allergy to soy, milk- and/or egg.
- •9. Mental status that is incompatible with the proper conduct of the study.
- •10. Occupation involving handling of ETEC or Vibrio cholerae currently, or in the past 3 years.
- •11. Reported average stool frequency of <1 or >3 per day.
- •12. 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 dosing, OR planned travel to endemic countries during the length of the study.
- •13. Use of antibiotics, norit, laxatives (up till 6 months prior to inclusion), cholesterol lowering agents, antacids, proton pump inhibitors and immune suppressive agents (up till 3 months prior to inclusion)
- •14. Vaccination for or ingestion of ETEC, cholera, or E coli heat labile toxin within 3 years prior to inclusion.
- •15. Vegans.
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