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

NCT04269174 | Unknown DMC

• 1 other identifier: AssiutU The utility of Biofire
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Chronic Diarrhoea; Antibiotic Resistant Strain; Polymerase Chain Reaction

Keywords

organic and functiona diarrhoea; pattern; utility

Outcome Measures

Primary Outcomes (2)

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

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

  one year

• To identify antibiotic sensitivity pattern of microbes

  Antibiotic sensitivity patterns for causative microbes.

  one year

Secondary Outcomes (1)

• Epidemiology of infectious causes in chronic diarrhoea

  one year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with diarrhea \> 4 weeks

You may not qualify if:

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

Sponsors & Collaborators

• Shaimaa Mahmoud Abd El-mouez: lead

Related Publications (2)

• Maharshak N, Ringel Y, Katibian D, Lundqvist A, Sartor RB, Carroll IM, Ringel-Kulka T. Fecal and Mucosa-Associated Intestinal Microbiota in Patients with Diarrhea-Predominant Irritable Bowel Syndrome. Dig Dis Sci. 2018 Jul;63(7):1890-1899. doi: 10.1007/s10620-018-5086-4. Epub 2018 May 17.

  PMID: 29777439 RESULT

• Buss SN, Leber A, Chapin K, Fey PD, Bankowski MJ, Jones MK, Rogatcheva M, Kanack KJ, Bourzac KM. Multicenter evaluation of the BioFire FilmArray gastrointestinal panel for etiologic diagnosis of infectious gastroenteritis. J Clin Microbiol. 2015 Mar;53(3):915-25. doi: 10.1128/JCM.02674-14. Epub 2015 Jan 14.

  PMID: 25588652 RESULT

Central Study Contacts

Shaimaa M Abd Elmouez, doctor

CONTACT

0201206053222; shaimaamahmoud886@gmail.com

asmaa om ahmed, professor

CONTACT

0201033153328; asomar_12@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principe investigator

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 13, 2020
• Study Start: February 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: January 1, 2021
• Last Updated: February 17, 2020

Record last verified: 2020-02