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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04269174
Recruitment Status : Not yet recruiting
First Posted : February 13, 2020
Last Update Posted : February 17, 2020
Information provided by (Responsible Party):
Shaimaa Mahmoud Abd El-mouez, Assiut University

Brief Summary:

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)

Condition or disease
Chronic Diarrhoea Antibiotic Resistant Strain Polymerase Chain Reaction

Detailed Description:


• 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.

A) Conventional methods:

Stool samples will be cultured on Selenite broth then subcultured on blood agar, chocolate agar, MacConkeys agar, Sorbitol MacConkys agar: Xylose Lysine Deoxycholate agar (XLD) ,Sabouraud dextrose agar (SDA), blood agar with 10um/ml ampicillin , Cambylobacter CVA agar plates.

  1. Identification of the bacterial organism:

    Pure colonies of isolated microorganisms were identified by:

    • Morphology on agar.
    • Gram stain film was made from the growth to identify morphology of the organism.
    • Biochemical reactions tests.
  2. Detection of antibiotic sensitivity pattern according to CLSI 2019 by disc diffusion method
  3. Confirmation of results by automated microbial system VITEK 2Compact.

B) Multiplex PCR: for Identification of different causative organisms by Biofire microarray (BioMerieux,France)

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: The Utility of Biofire Filmarray in Evaluation of Entero Pathogens Triggers in Patients With Chronic Diarrhea
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Primary Outcome Measures :
  1. Evaluation of utility of multiplex PCR in diagnosis of patients with chronic diarrhea. [ Time Frame: one year ]
    The performance of the FilmArray test in the diarrhea for each pathogen on the panel.

  2. To identify antibiotic sensitivity pattern of microbes [ Time Frame: one year ]
    Antibiotic sensitivity patterns for causative microbes.

Secondary Outcome Measures :
  1. Epidemiology of infectious causes in chronic diarrhoea [ Time Frame: one year ]
    causes of chronic diarrhoea of enrolled specimens will be evaluated at the end of the study.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients with chronic diarrhea recruited from Al-Rajhi Liver Hospital, Assiut University Hospitals, Assiut, Egypt.

  1. Inclusion criteria:

    Patients with diarrhea > 4 weeks

  2. Exclusion criteria:

Age below 18 years old and diarhhoea < 4 weeks.


Inclusion Criteria:

  • Patients with diarrhea > 4 weeks

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04269174

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Contact: Shaimaa M Abd Elmouez, doctor 0201206053222
Contact: asmaa om ahmed, professor 0201033153328

Sponsors and Collaborators
Shaimaa Mahmoud Abd El-mouez

Publications of Results:
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Responsible Party: Shaimaa Mahmoud Abd El-mouez, Principe investigator, Assiut University Identifier: NCT04269174    
Other Study ID Numbers: AssiutU The utility of Biofire
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shaimaa Mahmoud Abd El-mouez, Assiut University:
organic and functiona diarrhoea
Additional relevant MeSH terms:
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Signs and Symptoms, Digestive
Signs and Symptoms