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

February 12, 2020 updated by: Shaimaa Mahmoud Abd El-mouez

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)

Study Overview

Status

Unknown

Conditions

Detailed Description

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.

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)

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • Patients with diarrhea > 4 weeks

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year
To identify antibiotic sensitivity pattern of microbes
Time Frame: one year
Antibiotic sensitivity patterns for causative microbes.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaimaa Mahmoud Abd El-mouez

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2020

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

February 11, 2020

First Submitted That Met QC Criteria

February 12, 2020

First Posted (Actual)

February 13, 2020

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 12, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AssiutU The utility of Biofire

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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