NCT07533890招募中不适用
Fecal Microbiome Signature of Multi-Strain Probiotics Supplementation in Children and Adolescents With Inflammatory Bowel Disease - an Explanatory 1:1 Randomized Controlled Cross-Over Proof-of-Concept Trial With Blinded Outcome Assessment
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- abundance of specific bacteria
研究概览
简要总结
In this study the intestinal microbiome and metabolic profiles of patients with inflammatory bowel disease will be determined upon probiotic intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Diagnosis of inflammatory bowel disease according to actual guidelines (Porto Criteria)
- •General good health
- •Ability to understand and follow study procedures and understand informed consent
- •Age 5 -18 years
- •No probiotic therapy 4 weeks before entering into the study.
排除标准
- •Participation in other clinical studies interfering with study procedures.
- •Inability or contraindications to undergo the investigated intervention
- •Severe or acute flare of disease (for UC PUCAI score ≥35, for CD wPCDAI >40)
- •Treatment escalation within last 4 weeks for uncontrolled disease.
- •Antibiotic or probiotic therapy within the last 4 weeks.
研究组 & 干预措施
Probiotic
Experimental
8 week probiotic supplementation, followed by 6 weeks wash-out and 8 weeks oberservation
干预措施: Probiotic Formula (Other)
Observation
Other
8 week observation, followed by 6 weeks washout and 8 week probiotic supplementation
干预措施: Observation (Other)
结局指标
主要结局
abundance of specific bacteria
时间窗: 22 weeks
operational taxonomic units (OTC) presence of total counts at T0, T1,T2,T3
次要结局
- microbiome analysis(22 weeks)
- clinical response(22 weeks)
- laboratory response - local(22 weeks)
- laboratory response - systemic(22 weeks)
研究者
研究点 (1)
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