Occult Obscure Gastrointestinal Bleeding (OGIB) in Colonic Diverticulitis Using Polyglucosamine: a Registry Study Following a Standard Management Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change of Occult bleeding
研究概览
简要总结
To test the activity of a polyglucosamine (PG) together with a Standard Management protocol (SM) on the occult and obscure gastrointestinal bleeding (OGIB) and the clinical symptoms in patients suffering from colonic diverticulitis (CD).
详细描述
The trial was conducted in a single center and subjects were participating to the San Valentino Vascular Screening Project (SVVSP). Sixty patients with history of colonic diverticulitis (CD) and occult obscure gastrointestinal bleeding (OGIB) were recruited. All subjects were following a Standard Management (SM) protocol consisting of diet and lifestyle modifications, and were freely choosing to be treated with polyglucosamine (PG) or to follow the SM only. Two groups of 30 cases each were formed and followed for 3 months.
Diet was controlled three times (baseline and during the first and third month), through the Food Intake Assessment (FIA) which consisted of the weekly analysis of 25 different servings (e,g fruits, vegetables, pulses, first dish, meat, processed meat, cheese). The lifestyle modification consisted of physical exercise (9 MET (Metabolic Equivalents) -h/week of brisk walking) and oral hygiene.
The main variable was OGIB, that was measured using Hemoccult Sensa Fecal Occult Blood Procedure.
Ancillary variables where the hs-CRP (high sensitivity C Ractive Protein) and the daily gastrointestinal discomfort (GID) measured thorough a visual analogue scale (VAS) from 0 to 10.
All variables were taken at baseline, after one and three months with the exception of GID that was measured also after one week of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged between 55 to 65 years (males and females).
- •CD diagnosis.
- •DICA (Diverticular Inflammation and Complication Assessment) class DICA 2 or DICA
- •OGIB positive to Hemoccult Sensa Fecal Occult Blood Procedure.
排除标准
- •Subjects with Class DICA >
- •Therapy with mesalazine antibiotics and probiotics.
- •Cancer of any type (a part from benign polyposis),
- •Alcoholism.
- •Parkinsonism.
- •Alzheimer's Disease.
- •Severe depression.
- •Drug addiction.
结局指标
主要结局
Change of Occult bleeding
时间窗: Baseline - 1 month - 3 months
Bleeding in feces
次要结局
- Gastrointestinal discomfort(Baseline - 1 week - 1 month - 3 months)