Antibiotic Resistant Strain Clinical Trial
Official title:
The Utility of Biofire Filmarray in Evaluation of Entero Pathogens Triggers in Patients With Chronic Diarrhea
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)
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | January 2021 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with diarrhea > 4 weeks Exclusion Criteria: - Age below 18 years old and diarhhoea < 4 weeks. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Shaimaa Mahmoud Abd El-mouez |
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) — View Citation
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/s1 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | To identify antibiotic sensitivity pattern of microbes | Antibiotic sensitivity patterns for causative microbes. | one year | |
Secondary | Epidemiology of infectious causes in chronic diarrhoea | causes of chronic diarrhoea of enrolled specimens will be evaluated at the end of the study. | one year |
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