Effect of Intensive or Conventional Periodontal Therapy on the Gut Microbiome and Systemic Inflammation of Patients With Inflammatory Bowel Disease: a Single-blinded Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes in microbiome alpha diversity measured from stool samples at 3 months
研究概览
简要总结
Periodontitis and inflammatory bowel disease have been associated by meta-epidemiologic evidence, although their mechanistic connection needs to be further explored. Oral-gut axis is implicated in the pathogenesis of several chronic inflammatory conditions, but to date no studies have evaluated the impact of periodontal treatment on gut ecology. Thus, the present randomised clinical trial is aimed at investigating the effect of intensive or conventional periodontal therapy on the gut microbiome and parameters of systemic inflammation of patients diagnosed with inflammatory bowel disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical and instrumental diagnosis of ulcerative colitis or Crohn's disease
- •periodontitis Stage III or IV
- •BMI between 20 and 29 kg/m2
- •free diet
- •presence of at least 20 teeth
排除标准
- •Systemic diseases (including diabetes, thyroid, liver, or kidney diseases)
- •dietary allergies
- •use of antibiotics or probiotics during the previous 30 days
- •pregnancy or breast feeding
结局指标
主要结局
Changes in microbiome alpha diversity measured from stool samples at 3 months
时间窗: Baseline and 90 days
Taxonomic and functional variation of gut bacteria after treatment
次要结局
- Changes in periodontal pocket depth (PPD) at 3 months(Baseline and 90 days)
- Changes in microbiome alpha diversity measured from saliva samples at 3 months(Baseline and 90 days)
- Change of the inflammatory markers levels in plasma(Baseline and 90 days)
- Changes in mean clinical attachment level (CAL) at 3 months(Baseline and 90 days)
- Changes in full mouth bleeding score (FMBS) at 3 months(Baseline and 90 days)