NL-OMON56374招募中不适用
Establishing colonisation with non-toxigenic Clostridioides difficile in healthy volunteers. - CloDiCo
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
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 64（—）
入选标准
- •1. Subject is aged >= 18 and <= 45 years and in good health.
- •2. Subject has adequate understanding of the procedures of the study and is
- •able and willing to abide strictly thereby.
- •3. For female subjects: subject agrees to use adequate contraception and not to
- •breastfeed for the duration of study.
- •4. Subject has signed informed consent.
排除标准
- •1. Any physical or psychiatric illness or conditions that could threaten or
- •compromise the health of the subject during the study, influence their ability
- •to participate in the trial or interfere with the interpretation of the study
- •results, as determined by the trial physician.
- •2. Use of antibiotics (or other microbiota influencing products) within three
- •months prior to inclusion.
- •3. Known immunosuppressive condition, including infection with Human
- •Immunodeficiency Virus (HIV), use of systemic corticosteroids or other immune
- •modifying drugs (with exception of antihistamines and topical steroids).
- •4. Regular use (defined by more than once weekly) of proton-pump inhibitors or
- •H2- blockers during one month prior to inclusion.
- •5. The use of strong P-glycoprotein-inhibitors (like ciclosporin, ketoconazole,
- •erythromycin, clarithromycin, verapamil and amiodaron).
- •6. Known allergy to vancomycin, metronidazole or fidaxomicin.
- •7. Known allergy to glycerol.
- •8. Known immunodeficiency disorders.
- •9. Known gastro-intestinal disease including but not limited to inflammatory
- •bowel diseases (Crohn*s disease, Colitis Ulcerosa), recent gastro-intestinal
- •surgery, constipation defined by bowel movements less than every second day.
- •10. Positive fecal PCR with Clostridiodes or SSYC (Salmonella, Shigella,
- •Yersinia or Campylobacter spp.) at screening.
- •11. Any condition that would put household members at a greater risk for
- •transmission e.g. no access or use of flush toilet, household members belonging
- •to vulnerable populations such as persons who are immunocompromised, children
- •younger than 2 years of age and elderly older than 70 years of age.
- •12. For women of child bearing potential: a positive urine pregnancy test
- •before inclusion or lactating at screening / during the trial.
- •13. Being an employee or student of the Experimental bacteriology group or the
- •controlled human infection center at LUMC.
研究者
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