NL-OMON56821尚未招募不适用
Comparing food-induced gut microbiome shifts in vitro and in vivo - MAGIC Study
IZO food research B.V.0 个研究点目标入组 10 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
- 尚未招募
- 发起方
- 入组人数
- 10
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 >= 18 y
- •2. Healthy as assessed by general health questionnaire
- •3. BMI >=18.5 and <=30
- •4. Regular bowel habits, defined as at least once per 2 days
- •5. Adherence to habitual diet and lifestyle, no changes during study period
- •6. Signed informed consent
排除标准
- •1. Lower gastrointestinal conditions, such as diarrhea/loose stools or acute
- •gastrointestinal infection in the month before fecal donation, constipation, IBS
- •2. Diagnosed gastrointestinal disorders (for example, but not limited to,
- •ulcers, IBD, achalasia, eosinophilic esophagitis, hiatus hernia,
- •gastrointestinal cancer diagnosis or treatment within the past year), or
- •previous esophageal, gastric, small intestinal, or colonic surgery;
- •appendectomy or cholecystectomy more than 3 months prior to on-site study visit
- •are acceptable
- •3. Use of prebiotics or probiotics (an indicative list will be provided) within
- •4 weeks before fecal donation
- •4. Use of oral/IV antibiotics in 6 months before fecal donation
- •5. Fecal Microbiota Transplantation anytime in medical history
- •6. Use of laxatives within 2 weeks before fecal donation
- •7. Any clinically significant systemic infection at time of screening
- •8. Use of medication (for example, but not limited to, opioids, prokinetics,
- •anticholinergics, proton pump inhibitors (PPI)) or dietary supplements that
- •could affect bowel movement / gut motility, or with a history of systemic
- •disease that might affect gut motility according to the investigator; or which
- •could otherwise impact the results of the study
- •9. History of oropharyngeal dysphagia, or other swallowing disorder with a risk
- •of capsule as-piration
- •10. History of abdominal radiation treatment
- •11. Major genital and/or rectum prolapse at the time of screening or other
- •physical abnormali-ties that may impair capsule excretion according to the
- •investigator
- •12. Alcohol consumption >= 3 units/day
- •13. 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
- •14. Pregnancy
- •15. Not expected to be able to comply with study procedure including SIMBA
- •capsule recovery with - or without help, according to the investigator
- •16. NIZO employee or first degree relative
研究者
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