NCT06040515招募中不适用
Probiotic EcN in Symptomatic Patients After an Episode of Acute Colonic Diverticulitis: a Prospective Multicentre Observational Study.
Erasmo Spaziani12 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2023年5月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 145
- 试验地点
- 12
- 主要终点
- Median symptomatic score reduction after therapy with Escherichia coli Nissle 1917
研究概览
简要总结
The goal of this observational study is to assess the efficacy and safety of the probiotic Escherichia coli Nissle 1917 (EcN®, Ca.Di.Group S.p.A) in the treatment of symptomatic patients after an episode of both complicated and uncomplicated acute colonic diverticulitis.
The main question it aims to answer are:
- Is the studied probiotic able to significantly reduce symptoms, assessed by means of a validated and dedicated score?
- Is there any difference in microbiota among the study group at baseline and a selected cohort of patients subdivided in subjects with diverticulosis and asymptomatic subjects after an episode of acute uncomplicated diverticulitis or an episode of complicated diverticulitis submitted to surgery with colonic resection without stoma?
- Is there any difference in microbiota in the study group at baseline and after 3 and 6 months of treatment with the probiotic?
- Is there any correlation between microbiota modification and symptoms during follow-up?
- Is there any impact on fecal calprotectin values before and during probiotic therapy?
- Is there any modification of evacuation before and during follow-up?
- Is probiotic able to prevent recurrent episodes of acute diverticulitis during follow-up?
- The safety of the probiotic will be assessed during the follow-up. The study group will be assessed at baseline and during follow-up with a dedicated clinical score and Bristol stool scale. Microbiota and fecal calprotectin values will be also assessed at baseline and during follow-up. Microbiota at baseline will be also evaluated for comparison in the three selected groups with diverticulosis and both asymptomatic and symptomatic after an episode of acute diverticulitis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic patients three months after an episode of uncomplicated acute colonic diverticulitis;
- •Symptomatic patients six months after an episode of complicated acute colonic diverticulitis; submitted to .surgical colonic resection without stoma;
- •Patients with diverticulosis;
- •Asymptomatic patients three months after an episode of uncomplicated acute colonic diverticulitis;
- •Asymptomatic patients six months after an episode of complicated acute colonic diverticulitis; submitted to surgical colonic resection without stoma.
排除标准
- •Ongoing acute diverticulitis at radiologic assessment
- •Antibiotic therapy, both systemic and topic, and/or probiotics and/or mesalazine within four weeks before enrolment;
- •Lactulose-lactitol use within four weeks before enrolment;
- •Presence of chronic inflammatory bowel diseases;
- •Presence of Segmental Colitis Associated with Diverticulitis (SCAD);
- •Presence of ischemic colitis;
- •Severe chronic liver (Child-Pugh C) and/or pancreatic and/or renal diseases;
- •Patients with severe renal failure;
- •Presence of suspected/actual pregnancy;
- •Presence of recent/ongoing neoplasia, under oncological treatment within 6 months before enrolment;
- •Presence of COVID-19 infection;
- •Patients unable to give informed consent.
研究组 & 干预措施
Symptomatic patients after acute diverticulitis
Patients aged ≥18 with persistent symptoms at least three months after a radiologic and/or endoscopic documented acute diverticulitis or after six months of surgery for complicated acute diverticulitis.
Therapy with Escherichia coli Nissle 1917 (EcN®) will be prescribed for a global duration of six months with the following assumption schedule: 2 capsules b.i.d. during 4 weeks, followed by 1 capsule o.i.d during 20 days each month for 5 months.
干预措施: Probiotic Formula (Drug)
结局指标
主要结局
Median symptomatic score reduction after therapy with Escherichia coli Nissle 1917
时间窗: Six-months follow-up
Median symptomatic score assessed at baseline and during follow-up
次要结局
- Microbiota qualitative composition and median symptomatic score correlation(Baseline and during 6-month follow-up.)
- Concentration of fecal calprotectin(Baseline and during 6-month follow-up.)
- Bristol stool scale modification(Baseline and during 6-month follow-up.)
- Microbiota qualitative composition(Baseline)
- Microbiota qualitative composition modification(Baseline and during 6-month follow-up.)
- Prevention of recurrent acute diverticulitis(Six-month follow-up.)
- Safety(Six-month follow-up.)
研究者
Erasmo Spaziani
MD, PhD
University of Roma La Sapienza
研究点 (12)
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