The Impact of Parasitic Infection on Multiple Sclerosis and Nephrotic Syndrome

Parasitic Disease Clinical Trial

Official title:

The Impact of Parasitic Infection on the Course of Multiple Sclerosis and Nephrotic Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06256471
• Other study ID #: Parasitic infection
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: August 1, 2025

Study information

• Verified date: February 2024
• Source: Assiut University
• Contact: Monica Refaat, Demonstrator
• Phone: 01093466250
• Email: Monicarefaat24[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Inform authorities about the importance of management of parasitic infections in those patients.

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?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: August 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 50 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Nephrosis
• Nephrotic Syndrome
• Parasitic Disease
• Parasitic Diseases

Intervention

Other:
• Follow up of multiple sclerotic and nephrotic syndrome patients after 3 months
Follow up of multiple sclerotic and nephrotic syndrome patients after 3 months for detection of impact of parasitic infection on these diseases courses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

Correale 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline