Chronic DiarrhoeaNCT04269174
The Utility of Biofire Filmarray in Evaluation of Entero Pathogens Triggers in Patients With Chronic Diarrhea
An observational study of Chronic Diarrhoea and Antibiotic Resistant Strain, run by Shaimaa Mahmoud Abd El-mouez.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Diarrhoea, Antibiotic Resistant Strain, Polymerase Chain Reaction
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2020to Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients with diarrhea > 4 weeks
Who cannot join
- Age below 18 years old and diarhhoea < 4 weeks.
Trial locations and contacts
No sites are listed yet.
About this study
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)
Read the 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.
- 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.
- 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.
- Detection of antibiotic sensitivity pattern according to CLSI 2019 by disc diffusion method
- Confirmation of results by automated microbial system VITEK 2Compact.
- Multiplex PCR: for Identification of different causative organisms by Biofire microarray (BioMerieux,France)
- Keywords
- organic and functiona diarrhoea, pattern, utility
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
To identify antibiotic sensitivity pattern of microbes
Antibiotic sensitivity patterns for causative microbes.
Measured: one year
Secondary outcomes (1)
Epidemiology of infectious causes in chronic diarrhoea
causes of chronic diarrhoea of enrolled specimens will be evaluated at the end of the study.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study startFeb 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic DiarrhoeaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaimaa Mahmoud Abd El-mouez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shaimaa Mahmoud Abd El-mouez, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269174
- Sponsor's protocol ID
- AssiutU The utility of Biofire
- Status last verified
- Feb 2020
- First submitted
- 11 Feb 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29777439Buss 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.
PubMed 25588652
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Biofire Filmarray in Evaluation of Entero Pathogens Triggers in Patients With Chronic Diarrhea
- ClinicalTrials.gov ID
- NCT04269174
- Acronym / sponsor ID
- AssiutU The utility of Biofire
- Keywords
- organic and functiona diarrhoea, pattern, utility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shaimaa Mahmoud Abd El-mouezUniversity, hospital or other
- Study start
- Feb 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 13 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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.
- 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.
- 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.
- Detection of antibiotic sensitivity pattern according to CLSI 2019 by disc diffusion method
- Confirmation of results by automated microbial system VITEK 2Compact.
- Multiplex PCR: for Identification of different causative organisms by Biofire microarray (BioMerieux,France)
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients with diarrhea > 4 weeks
Key exclusion criteria (1 listed)
- Age below 18 years old and diarhhoea < 4 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
To identify antibiotic sensitivity pattern of microbes
Time frame: one year
Antibiotic sensitivity patterns for causative microbes.
1 secondary outcome
Epidemiology of infectious causes in chronic diarrhoea
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Results publication: PubMed 29777439Maharshak 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.
- Results publication: PubMed 25588652Buss 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Diarrhoea and Antibiotic Resistant Strain, run by Shaimaa Mahmoud Abd El-mouez.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaimaa M Abd Elmouez, doctor (0201206053222, shaimaamahmoud886@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of utility of multiplex PCR in diagnosis of patients with chronic diarrhea. (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04269174, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.