Liver CirrhosisNCT05856721
Pattern of Intestinal Parasitic Infection Among Cirrhotic Patients in Sohag University Hospital
A study testing stool analysis in people with Liver Cirrhosis, run by Sohag University at 1 site in Egypt.
Trial summary
Chronic hepatic illness is one of the most serious health issues . Liver cirrhosis as the latest phase of chronic liver disease causes a disorder called cirrhosis-associated immune dysfunction syndrome (CAIDS) . Cirrhosis comes to be a systemic disease, with several organ disorders. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- stool analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2023to Jun 2024
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed to have liver cirrhosis with or without hepatocellular carcinoma.
Who cannot join
- . Cirrhotic patients with renal impairment.
- . Cirrhotic patients with cardiac diseases.
Trial locations and contacts
1 site in 1 country.
Asmaa N Mohamed, professor contact
About this study
Chronic hepatic illness is one of the most serious health issues . Liver cirrhosis as the latest phase of chronic liver disease causes a disorder called cirrhosis-associated immune dysfunction syndrome (CAIDS) . Cirrhosis comes to be a systemic disease, with several organ disorders. At this phase, patients become highly vulnerable to various infections because of CAIDS, which comprises both innate and adaptive immunity). Patients with hepatic cirrhosis and ascites are more liable to other complications of liver disease, including hyponatremia, refractory ascites, or hepatorenal syndrome (HRS) . Liver cirrhotic patients are considered to be as immunosuppressed and are vulnerable to a different species of entero-parasites .
Intestinal parasitic diseases have been reported in association with diabetes mellitus (DM) which is considered a predisposing factor to infection in cirrhotic patients . Immunosuppression among DM cases is due to increased blood glucose levels, which modifies several immune responses and this renders the body susceptible to various opportunistic infections comprising parasitic infections
Intestinal parasites such as Blastocystis hominis, Cryptosporidium spp., Isospora belli, Cyclospora cayetanensis, and Microsporidia have appeared as significant opportunistic parasites that are responsible for severe illness in immunocompromised patients , subsequently, patients suffer from severe morbidity and high mortality).
- Conditions
- Liver Cirrhosis
- Being tested
- stool analysis
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stool analysisDiagnostic test
Detection of prevalence and pattern of intestinal parasitic infection in cirrhotic patients and the difference between cirrhotic patients and non-cirrhotic patients with no comorbidity.
To determine the most common risk factors of intestinal parasitic infection in cirrhotic patients.
| Study group | Role | What they receive |
|---|---|---|
| cases group | Active comparator | One hundred patients with liver cirrhosis and GIT complaints Receives: Diagnostic Test: stool analysis |
| control group | Active comparator | One hundred patients with GIT complaints but not have any cormobidity Receives: Diagnostic Test: stool analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pattern of Intestinal Parasitic Infection Among Cirrhotic Patients
Detection of prevalence and pattern of intestinal parasitic infection in cirrhotic patients and the difference between cirrhotic patients and non-cirrhotic patients with no comorbidity.
To determine the most common risk factors of intestinal parasitic infection in cirrhotic patients
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study startJun 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Nady Abdelaal, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856721
- Sponsor's protocol ID
- Soh-Med-23-04-13MS
- Status last verified
- May 2023
- First submitted
- 3 May 2023
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Arvaniti V, D'Amico G, Fede G, Manousou P, Tsochatzis E, Pleguezuelo M, Burroughs AK. Infections in patients with cirrhosis increase mortality four-fold and should be used in determining prognosis. Gastroenterology. 2010 Oct;139(4):1246-56, 1256.e1-5. doi: 10.1053/j.gastro.2010.06.019. Epub 2010 Jun 14.
PubMed 20558165Bernardi M, Moreau R, Angeli P, Schnabl B, Arroyo V. Mechanisms of decompensation and organ failure in cirrhosis: From peripheral arterial vasodilation to systemic inflammation hypothesis. J Hepatol. 2015 Nov;63(5):1272-84. doi: 10.1016/j.jhep.2015.07.004. Epub 2015 Jul 17.
PubMed 26192220Bonnel AR, Bunchorntavakul C, Reddy KR. Immune dysfunction and infections in patients with cirrhosis. Clin Gastroenterol Hepatol. 2011 Sep;9(9):727-38. doi: 10.1016/j.cgh.2011.02.031. Epub 2011 Mar 11.
PubMed 21397731El-Shazly LB, El-Faramawy AA, El-Sayed NM, Ismail KA, Fouad SM. Intestinal parasitic infection among Egyptian children with chronic liver diseases. J Parasit Dis. 2015 Mar;39(1):7-12. doi: 10.1007/s12639-013-0346-x. Epub 2013 Sep 3.
PubMed 25698851
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern of Intestinal Parasitic Infection Among Cirrhotic Patients in Sohag University Hospital
- ClinicalTrials.gov ID
- NCT05856721
- Acronym / sponsor ID
- Soh-Med-23-04-13MS
- Conditions
- Liver Cirrhosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 12 May 2023 (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 hepatic illness is one of the most serious health issues . Liver cirrhosis as the latest phase of chronic liver disease causes a disorder called cirrhosis-associated immune dysfunction syndrome (CAIDS) . Cirrhosis comes to be a systemic disease, with several organ disorders. At this phase, patients become highly vulnerable to various infections because of CAIDS, which comprises both innate and adaptive immunity). Patients with hepatic cirrhosis and ascites are more liable to other complications of liver disease, including hyponatremia, refractory ascites, or hepatorenal syndrome (HRS) . Liver cirrhotic patients are considered to be as immunosuppressed and are vulnerable to a different species of entero-parasites .
Intestinal parasitic diseases have been reported in association with diabetes mellitus (DM) which is considered a predisposing factor to infection in cirrhotic patients . Immunosuppression among DM cases is due to increased blood glucose levels, which modifies several immune responses and this renders the body susceptible to various opportunistic infections comprising parasitic infections
Intestinal parasites such as Blastocystis hominis, Cryptosporidium spp., Isospora belli, Cyclospora cayetanensis, and Microsporidia have appeared as significant opportunistic parasites that are responsible for severe illness in immunocompromised patients , subsequently, patients suffer from severe morbidity and high mortality).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases group | Active comparator | Diagnostic Test: stool analysisOne hundred patients with liver cirrhosis and GIT complaints |
| control group | Active comparator | Diagnostic Test: stool analysisOne hundred patients with GIT complaints but not have any cormobidity |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed to have liver cirrhosis with or without hepatocellular carcinoma.
Key exclusion criteria (2 listed)
- . Cirrhotic patients with renal impairment.
- . Cirrhotic patients with cardiac diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stool analysisDetection of prevalence and pattern of intestinal parasitic infection in cirrhotic patients and the difference between cirrhotic patients and non-cirrhotic patients with no comorbidity. To determine the most common risk factors of intestinal parasitic infection in cirrhotic patients. | Diagnostic test | cases group, control group |
Primary outcome
Pattern of Intestinal Parasitic Infection Among Cirrhotic Patients
Time frame: 12 months
Detection of prevalence and pattern of intestinal parasitic infection in cirrhotic patients and the difference between cirrhotic patients and non-cirrhotic patients with no comorbidity. To determine the most common risk factors of intestinal parasitic infection in cirrhotic patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Background: PubMed 20558165Arvaniti V, D'Amico G, Fede G, Manousou P, Tsochatzis E, Pleguezuelo M, Burroughs AK. Infections in patients with cirrhosis increase mortality four-fold and should be used in determining prognosis. Gastroenterology. 2010 Oct;139(4):1246-56, 1256.e1-5. doi: 10.1053/j.gastro.2010.06.019. Epub 2010 Jun 14.
- Background: PubMed 26192220Bernardi M, Moreau R, Angeli P, Schnabl B, Arroyo V. Mechanisms of decompensation and organ failure in cirrhosis: From peripheral arterial vasodilation to systemic inflammation hypothesis. J Hepatol. 2015 Nov;63(5):1272-84. doi: 10.1016/j.jhep.2015.07.004. Epub 2015 Jul 17.
- Background: PubMed 21397731Bonnel AR, Bunchorntavakul C, Reddy KR. Immune dysfunction and infections in patients with cirrhosis. Clin Gastroenterol Hepatol. 2011 Sep;9(9):727-38. doi: 10.1016/j.cgh.2011.02.031. Epub 2011 Mar 11.
- Background: PubMed 25698851El-Shazly LB, El-Faramawy AA, El-Sayed NM, Ismail KA, Fouad SM. Intestinal parasitic infection among Egyptian children with chronic liver diseases. J Parasit Dis. 2015 Mar;39(1):7-12. doi: 10.1007/s12639-013-0346-x. Epub 2013 Sep 3.
- Individual participant dataSharing planned: Undecided
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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.
Asmaa N Mohamed, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stool analysis in people with Liver Cirrhosis, run by Sohag University at 1 site in Egypt.
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 2 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 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Nada N Abdelaal, residant (01064067855, nadanady@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pattern of Intestinal Parasitic Infection Among Cirrhotic Patients (time frame: 12 months). 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 NCT05856721, which also lists 4 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 12 May 2023.