Parasitic DiseaseNCT06256471
The Impact of Parasitic Infection on Multiple Sclerosis and Nephrotic Syndrome
An observational study of Parasitic Disease, run by Assiut University.
Trial summary
1. Detection of the prevalence of parasitic infections amoung patients with multiple sclerosis and nephrotic syndrome at Assiut University Hospitals. 2. Detection of the effect of parasitic infections on these diseases courses. 3. Read more about this study
- Who is it for?
- Ages Up to 50 years
- Conditions the study is for
- Parasitic Disease
- What is being tested?
- Follow up of multiple sclerotic and nephrotic syndrome patients after 3 months
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 Aug 2025
- 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 Up to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: clinically and laboratory-confirmed autoimmune diseases according to: multiple sclerosis attending Neurology Department at Assiut University Hospitals and clinically and laboratory-confirmed autoimmune diseases according to: nephrotic syndrome attending Pediatric Department at Assiut University Hospitals.
Who may be able to join
- 1- clinically and laboratory-confirmed autoimmune diseases according to: multiple sclerosis attending Neurology Department at Assiut University Hospitals.
- 2- clinically and laboratory-confirmed autoimmune diseases according to: nephrotic syndrome attending Pediatric Department at Assiut University Hospitals.
Who cannot join
- Patients with other commodities especially which cause secondary immune deficiencies like diabetes mellitus, patients with chronic liver disease or kidney diseases other than NS, malignancies and pregnant females.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Impact of Parasitic Infection on the Course of Multiple Sclerosis and Nephrotic Syndrome
- Detection of the prevalence of parasitic infections amoung patients with multiple sclerosis and nephrotic syndrome at Assiut University Hospitals.
- Detection of the effect of parasitic infections on these diseases courses.
- Inform authorities about the importance of management of parasitic infections in those patients.
Read the detailed description
Parasitic protozoal infections have prominent immunomodulatory changes in different autoimmune diseases. Moreover, helminths and their derivatives were established to have a protective role. Clinical trials of autoimmune diseases have tested the obvious helminths' immunomodulatory effect in inflammatory bowel disease, multiple sclerosis and rheumatoid arthritis . Autoimmunity is the immune system's inability to differentiate between foreign and self-antigens, resulting in damage of the healthy tissues . Recently, strong epidemiological studies revealed a steady increase in autoimmune diseases incidence in the developed countries. Also, The prevalence of the autoimmune diseases varies between rural and urban areas within the same country . The high records of autoimmune diseases incidences in these countries is attributed to the decline in infectious diseases prevalence "hygiene hypothesis ".
Multiple sclerosis (MS) is an inflammatory demyelinating disease affecting the CNS. Although its etiology remains obscure, several lines of evidence show that autoimmunity has a major role in the disease pathogenesis . Recent researches explain that parasitic infections can alter the disease course . Which is in the form of decreased number of relapses, minimal change in disability scores and lower MRI activity .
Childhood nephrotic syndrome (NS) is a worldwide disease with incidence and prognosis vary greatly according to the geographic distribution, with a prevalence of 15 per 100 000 under 16 years of age and higher incidence in South Asian (Pakistani, Indian, and Bangladeshi) and Arab children . NS is considered as a disease with immune impairment, Also some infections are found to be related to nephrotic syndrome . Parasitic infections may possibly be nonspecific triggers of NS . For instance, parasitic infections have been known to be associated with immune complex- mediated glomerular lesions . Moreover, parasites can mediate Altered T-helper cell cytokine expression, binding of autoantibodies to glomerular autoantigens, and immune complex formation .
The present study clarifies two very interesting and yet unexplored potentials, Do parasitic infections aggravate or ameliorate the course of autoimmune diseases? Also, what is the prevalence of parasitic infections in MS and NS in our governorate?
- Conditions
- Parasitic Disease
- Being tested
- Follow up of multiple sclerotic and nephrotic syndrome patients after 3 months
- Medical subject headings
- Parasitic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow up of multiple sclerotic and nephrotic syndrome patients after 3 monthsOther
Follow up of multiple sclerotic and nephrotic syndrome patients after 3 months for detection of impact of parasitic infection on these diseases courses
What is being measured
The primary outcome is the main question the study is designed to answer.
The impact of parasitic infection on multiple sclerosis and nephrotic syndrome
Detection of prevalence of parasitic infection on multiple sclerosis and nephrotic syndrome and the effect of parasitic infection on these diseases courses
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Aug 2025 (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 Parasitic DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monica Refaat Hakeem Saweries, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256471
- Sponsor's protocol ID
- Parasitic infection
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Strachan DP. Hay fever, hygiene, and household size. BMJ. 1989 Nov 18;299(6710):1259-60. doi: 10.1136/bmj.299.6710.1259. No abstract available.
PubMed 2513902Correale J, Farez M. Association between parasite infection and immune responses in multiple sclerosis. Ann Neurol. 2007 Feb;61(2):97-108. doi: 10.1002/ana.21067.
PubMed 17230481
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Parasitic Infection on the Course of Multiple Sclerosis and Nephrotic Syndrome
- ClinicalTrials.gov ID
- NCT06256471
- Acronym / sponsor ID
- Parasitic infection
- Conditions
- Parasitic Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 13 Feb 2024 (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.
- Detection of the prevalence of parasitic infections amoung patients with multiple sclerosis and nephrotic syndrome at Assiut University Hospitals.
- Detection of the effect of parasitic infections on these diseases courses.
- Inform authorities about the importance of management of parasitic infections in those patients.
Detailed description
Parasitic protozoal infections have prominent immunomodulatory changes in different autoimmune diseases. Moreover, helminths and their derivatives were established to have a protective role. Clinical trials of autoimmune diseases have tested the obvious helminths' immunomodulatory effect in inflammatory bowel disease, multiple sclerosis and rheumatoid arthritis . Autoimmunity is the immune system's inability to differentiate between foreign and self-antigens, resulting in damage of the healthy tissues . Recently, strong epidemiological studies revealed a steady increase in autoimmune diseases incidence in the developed countries. Also, The prevalence of the autoimmune diseases varies between rural and urban areas within the same country . The high records of autoimmune diseases incidences in these countries is attributed to the decline in infectious diseases prevalence "hygiene hypothesis ".
Multiple sclerosis (MS) is an inflammatory demyelinating disease affecting the CNS. Although its etiology remains obscure, several lines of evidence show that autoimmunity has a major role in the disease pathogenesis . Recent researches explain that parasitic infections can alter the disease course . Which is in the form of decreased number of relapses, minimal change in disability scores and lower MRI activity .
Childhood nephrotic syndrome (NS) is a worldwide disease with incidence and prognosis vary greatly according to the geographic distribution, with a prevalence of 15 per 100 000 under 16 years of age and higher incidence in South Asian (Pakistani, Indian, and Bangladeshi) and Arab children . NS is considered as a disease with immune impairment, Also some infections are found to be related to nephrotic syndrome . Parasitic infections may possibly be nonspecific triggers of NS . For instance, parasitic infections have been known to be associated with immune complex- mediated glomerular lesions . Moreover, parasites can mediate Altered T-helper cell cytokine expression, binding of autoantibodies to glomerular autoantigens, and immune complex formation .
The present study clarifies two very interesting and yet unexplored potentials, Do parasitic infections aggravate or ameliorate the course of autoimmune diseases? Also, what is the prevalence of parasitic infections in MS and NS in our governorate?
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- clinically and laboratory-confirmed autoimmune diseases according to: multiple sclerosis attending Neurology Department at Assiut University Hospitals and clinically and laboratory-confirmed autoimmune diseases according to: nephrotic syndrome attending Pediatric Department at Assiut University Hospitals.
Key inclusion criteria (2 listed)
- 1- clinically and laboratory-confirmed autoimmune diseases according to: multiple sclerosis attending Neurology Department at Assiut University Hospitals.
- 2- clinically and laboratory-confirmed autoimmune diseases according to: nephrotic syndrome attending Pediatric Department at Assiut University Hospitals.
Key exclusion criteria (1 listed)
- Patients with other commodities especially which cause secondary immune deficiencies like diabetes mellitus, patients with chronic liver disease or kidney diseases other than NS, malignancies and pregnant females.
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 |
|---|---|---|
| Follow up of multiple sclerotic and nephrotic syndrome patients after 3 monthsFollow up of multiple sclerotic and nephrotic syndrome patients after 3 months for detection of impact of parasitic infection on these diseases courses | Other | – |
Primary outcome
The impact of parasitic infection on multiple sclerosis and nephrotic syndrome
Time frame: Baseline
Detection of prevalence of parasitic infection on multiple sclerosis and nephrotic syndrome and the effect of parasitic infection on these diseases courses
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Background: PubMed 2513902Strachan DP. Hay fever, hygiene, and household size. BMJ. 1989 Nov 18;299(6710):1259-60. doi: 10.1136/bmj.299.6710.1259. No abstract available.
- Background: PubMed 17230481Correale J, Farez M. Association between parasite infection and immune responses in multiple sclerosis. Ann Neurol. 2007 Feb;61(2):97-108. doi: 10.1002/ana.21067.
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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 Parasitic Disease, run by Assiut University.
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 2 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 13 Feb 2024. 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 Monica Refaat, Demonstrator (01093466250, Monicarefaat24@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The impact of parasitic infection on multiple sclerosis and nephrotic syndrome (time frame: Baseline). 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 NCT06256471, 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 13 Feb 2024.