NL-OMON51738尚未招募不适用
Prediction of dietary intervention efficacy in mild ulcerative colitis patients based on fecal microbiome signatures - PREDUCTOME study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
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. Male and female subjects aged 18 to 65 years
- •2. Body Mass Index (BMI) between 18 and 30 kg/m2 (self-reported)
- •3. Ulcerative Colitis confirmed via previous endoscopy and histology
- •4. Mild active UC as defined by Patient Simple Clinical Colitis Activity Index
- •(P-SCCAI) score of 3 to 5 (range 0 to 19)
- •5. Frequent relapse (at least one exacerbation in the last two years)
- •6. No known allergy to any components of the study product (self-reported)
- •7. Signed informed consent
- •8. Stable UC medication defined as no switch to other medication or no dose
- •9. mobile phone on which apps (used for questionnaires) can be downloaded
- •(iOS version 9 and newer, Android version 4.4 and newer. Phones manufactured
- •after 2013 are usually suitable)
- •10. stable dietary pattern during the study
排除标准
- •1. Any other underlying disease of the GI-tract or previous bowel surgery,
- •except cholecystectomy and appendectomy
- •2. Pregnancy or intending to become pregnant during the study
- •3. Use of medication that can interfere with the study outcomes, as judged by
- •the medical supervisor
- •4. The need for antibiotic use during the study period
- •5. Systemic antibiotics and proton pump inhibitors (except for omeprazole and
- •pantoprazole with dosage <20 mg), prebiotic supplements, probiotic supplements
- •four weeks prior to study start.
- •6. Currently participating in another intervention study
- •7. Acquaintances of anyone in the research team
研究者
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