跳至主要内容
临床试验/NCT04269174
NCT04269174Unknown不适用

The Utility of Biofire Filmarray in Evaluation of Entero Pathogens Triggers in Patients With Chronic Diarrhea

Shaimaa Mahmoud Abd El-mouez0 个研究点目标入组 50 人开始时间: 2020年2月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
主要终点
To identify antibiotic sensitivity pattern of microbes

研究概览

简要总结

Chronic diarrhea is a common condition and a key symptom in many disorders. It is a major cause of morbidity and mortality worldwide and one of the most common reasons for referral to a gastroenterology clinic.The prevalence varies depending on population and the definition of diarrhea used. It affects approximately 5% of the population at any given point in time, although the exact prevalence is unknown. Diarrhea is associated with 4 pathophysiological mechanisms: osmotic, secretory, exudative and altered motility. It is more useful to classify patients presenting with symptoms of diarrhea according to ''functional'' or ''organic'' characteristics. It is usually difficult to make a reliable differentiation between organic and functional causes in patients with chronic diarrhea based only on history and physical examination .

The standard evaluation of patients with chronic diarrhea that begins with a detailed history, a careful physical examination and then basic diagnostic tests is critical for optimal treatment and prevention. Initially, thought needs to exclude several other possibilities as (a) fecal incontinence masquerading as diarrhea, (b) iatrogenic diarrhea due to drugs, surgery, or therapeutic radiation, (c) chronic infections, and (d) irritable bowel syndrome with diarrhea (IBS-D).

The detection of a broad array of potentially offending agents has traditionally required a combination of microbiologic approaches, including bacterial culture, antigen detection, microscopy, and polymerase chain reaction (PCR). The new multiplex PCR-based panels have several advantages over conventional methods including (i) reduced sample volume requirements, (ii) broad coverage without the need to select specific tests, (iii) enhanced ability to detect coinfections (iv) increased sensitivity and specificity as high as 97-100% and (v) higher throughput.The food and drug administration (FDA) cleared and recommended the use of FilmArray GI panel (BioFire Diagnostics), which targets 22 analytes (bacteria with bacterial toxin, viruses, and parasites)

详细描述

Investigations:

• Routine laboratory investigation: Complete blood picture and differential WBCs count, liver, kidney function tests, RBG, Na, K, CRP, ESR.

• Microbilogical Investigations:

To ensure that good specimens are provided for examination, it is important to note the following:

  • A sterile clean dry container must be used for the collection of fecal samples.
  • The specimen should be brought to the lab as soon as possible.
  • The specimen container should be clearly labeled with the patient's name, date, and time of passage of the specimen.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with diarrhea > 4 weeks

排除标准

  • Age below 18 years old and diarhhoea < 4 weeks.

结局指标

主要结局

To identify antibiotic sensitivity pattern of microbes

时间窗: one year

Antibiotic sensitivity patterns for causative microbes.

Evaluation of utility of multiplex PCR in diagnosis of patients with chronic diarrhea.

时间窗: one year

The performance of the FilmArray test in the diarrhea for each pathogen on the panel.

次要结局

  • Epidemiology of infectious causes in chronic diarrhoea(one year)

研究者

发起方
Shaimaa Mahmoud Abd El-mouez
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Shaimaa Mahmoud Abd El-mouez

Principe investigator

Assiut University

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