NCT02539849已完成不适用
Effect of Prebiotic Fructo-oligosaccharides (FOS) on Intestinal Abundance of Faecalibacterium Prausnitzii in Patients With Crohn´s Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 5
- 主要终点
- FOS increases counts of Faecalibacterium prausnitzii in faecal samples from Crohn's disease patients
研究概览
简要总结
FOS improve gut colonization by Faecalibacterium prausnitzii in patients with Crohn's disease
详细描述
To demonstrate that FOS increases counts of Faecalibacterium prausnitzii in faecal samples from Crohn's disease patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 and 65 years old
- •Crohn's disease patients
- •Inflammatory activity confirmed by imaging techniques (colonoscopy or magnetic resonance imaging (MRI))
- •Refractory inflammatory luminal disease (with or without perianal involvement) at any level of the gastrointestinal tract requiring therapy with adalimumab,according to standard clinical practice.
- •Stable maintenance of any other medication (corticosteroids and / or immunosuppressants and/or 5-aminosalicylic acid (5-ASA)) for the past 4 weeks
- •Screening tests required for a safe administration of anti tumour necrosis factor (anti-TNF) antibodies will be performed according to standard clinical practice
排除标准
- •Subjects consuming prebiotic supplements (inulin, FOS, galactooligosaccharides (GOS)) in their regular diet.
- •Antibiotic use within the past 2 months
- •Previous anti-TNF therapy.
研究组 & 干预措施
adalimumab + FOS
Other
Adalimumab will be administered during 12 weeks in combination with daily FOS 6g. (FOS administration will start 2 weeks before Adalimumab)
干预措施: FOS (Dietary Supplement)
adalimumab + FOS
Other
Adalimumab will be administered during 12 weeks in combination with daily FOS 6g. (FOS administration will start 2 weeks before Adalimumab)
干预措施: Adalimumab (Drug)
结局指标
主要结局
FOS increases counts of Faecalibacterium prausnitzii in faecal samples from Crohn's disease patients
时间窗: 14 weeks
次要结局
未报告次要终点
研究者
研究点 (5)
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