NCT03225261已完成2 期
The Effect of Citrus Extract Administration on Gastrointestinal Health
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- The effect on intestinal inflammation, measured by fecal calprotectin levels.
研究概览
简要总结
This randomized, parallel, double-blind, placebo-controlled trial aims to determine the effects of daily administration of citrus extract over a period of 8 weeks on gastrointestinal health in patients with irritable bowel syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with IBS
- •Calprotectin levels 15-150 µg/g feces
- •Age 18-70 years
- •BMI < 35 kg/m2
排除标准
- •Comorbidities that may influence gut microbiota composition or which might limit participation in or completion of the study protocol (to be decided by the principle investigator)
- •Abdominal surgery interfering with gastrointestinal function (to be decided by the principle investigator)
- •Use of immunosuppressive drugs within 3 months before study period
- •Use of other medication interfering with endpoints
- •Changes in medication that may significantly affect the study outcome according to the investigator's judgment within 1 month prior to the study
- •Changes in clinical activity scores within 3 weeks prior to the study
- •Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator) in the 180 days prior to the study
- •Use of dietary supplements containing antioxidants, minerals and vitamins
- •Excessive intake of foods with a high polyphenol concentration
- •Use of antibiotics within 3 months prior to the start of study
- •Use of pre-or probiotics within 1 month prior to the study
- •Use of oral corticosteroids within 1 month prior to the study
- •Blood donation within 1 month prior to the study
- •Known pregnancy or lactation.
- •Excessive drinking (>20 alcoholic consumptions per week)
- •History of any side effects towards the intake of flavonoids or citrus fruits
结局指标
主要结局
The effect on intestinal inflammation, measured by fecal calprotectin levels.
时间窗: 8 weeks
The primary objective is to assess the effect of 500 mg citrus extract on intestinal flammation after 8 weeks of administration, by measuring fecal calprotectin in IBS patients with moderately increased fecal calprotectin levels.
次要结局
- The effect on disease symptoms, measured by patient reported outcomes (GSRS).(8 weeks)
- The effect on fecal microbiota composition, assessed by next generation sequencing.(8 weeks)
- The effect on blood markers for antioxidant capacity, measured by blood total antioxidant capacity.(8 weeks)
- The effect on microbial metabolic activity, measured by fecal short chain fatty acids (SCFA).(8 weeks)
- The effect on fecal microbiota functional capacity, assessed by next generation sequencing.(8 weeks)
- The effect on disease symptoms, measured by patient reported outcomes (symptom diary).(8 weeks)
- The effect on the systemic immune response, measured by cytokine production capacity of stimulated whole blood(8 weeks)
- The effect on stool frequency, measured by Bristol Stool Chart.(8 weeks)
- The effect on blood markers for oxidative stress, measured by MDA concentration in blood.(8 weeks)
- The effect on stool consistency, measured by Bristol Stool Chart.(8 weeks)
研究者
Yala Stevens
MSc.
Maastricht University Medical Center
研究点 (2)
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