Does a Daily Dose of the Probiotic Lactobacillus Casei Shirota Prevent Acute Episodes of Diverticulitis (LACTOPRoD) - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Number of episodes of acute diverticulitis
研究概览
简要总结
There is evidence to show that daily probiotic Lactobacillus casei Shirota (LcS) in the form of Yakult fermented milk supports a healthy balanced population of "friendly" gut bacteria. This, coupled with evidence from four European trials showing probiotic benefit for recurrent diverticulitis and an understanding of how the disease develops, indicates that LcS may also be beneficial. The investigators plan to undertake a pilot study investigating whether consumption of once daily probiotic LcS as Yakult fermented milk would help either prevent attacks of diverticulitis completely or significantly reduce frequency of attacks. Subjects will be recruited from Surrey primary care units and will be closely monitored for 12 months whilst being supplied with a daily dose of for the full 12 months to see if this improves gut health.
详细描述
Because dietary fibre, obesity and diabetes are all confounding factors that influence the frequency and severity of attacks of diverticulitis, the research project will take account of this by:
- Monitoring dietary fibre using a diet diary
- Measurement of height and weight to determine BMI
- Screening for undiagnosed diabetes and pre-diabetes
As well as keeping a diet diary, subjects will be asked to keep a general health diary, and to complete gut health questionnaires at start, 6 months and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A history of two episodes of UAD treated with antibiotics in the last five years.
- •Diverticulosis confirmed by colonoscopy, barium enema, USS, CT or MRI imaging or at surgery.
- •Agreement to consume one bottle of Yakult daily for 12 months
- •Availability of space in the domestic refrigerator for storage of Yakult units
- •Able to access depot (local primary care premises or chemist) to collect regular supplies of Yakult
- •Able to cope with keeping a diary etc.
- •Willing to take Yakult supplies and a cold bag on holiday to ensure as near as possible continuous daily doses (certainly never more than one week break as Lactobacilli casei will persist in the human gut for at least one week
- •Capable of giving informed consent
- •Aged ≥ 50 and ≤ 75 years at commencement of trial.
排除标准
- •Recent history of peptic ulcer
- •Chronic renal insufficiency
- •Ongoing or past major diverticulitis complications
- •Any serious debilitating illness (cancers, cardiovascular disease etc. but not DM)
- •Dementias or memory problems
- •Regular probiotic consumption over the past year.
- •Undergoing immunosuppressive therapy or treatment
- •Lactose intolerance or intolerance to dairy products
- •Immunosuppressed patients
研究组 & 干预措施
Yakult 62 ml daily
干预措施: Yakult (Dietary Supplement)
结局指标
主要结局
Number of episodes of acute diverticulitis
时间窗: 12 months period of taking daily probiotic
An episode of diverticulitis will be judged as having occured when there is left iliac pain and tenderness judged by the patient's genral practitioner to be due to acute diverticulitis and to be sufficiently severe as to require a course of antibiotics
次要结局
- Gut symptoms assessed by a validated questionnaire at o months, 6 months and 12 months(12 months)