ClinicalTrials.gg
Not yet recruitingNCT06256471Updated Feb 13, 2024

The Impact of Parasitic Infection on Multiple Sclerosis and Nephrotic Syndrome

An observational study in Parasitic Disease, sponsored by Assiut University. Not yet recruiting. Open to participants aged Up to 50 Years. Per ClinicalTrials.gov, last updated 2024-02-13.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 5 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
200
Ages
Up to 50 Years
Sex
All
01

Study 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.
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?

02

Conditions studied

  • Parasitic Disease

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03

In context

Parasitic Diseases

55 studies on the registry are indexed under Parasitic Diseases; 8 are open to participants now.

This study's planned enrollment of 200 is below the median of 400 across 13 observational studies indexed under Parasitic Diseases.

Browse Parasitic Diseases studies →

Lead sponsor

Assiut University is the lead sponsor of 5,079 studies on the registry; 2,177 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 1- clinically and laboratory-confirmed 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

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, and pregnant females.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
200 participants (estimated)
Patient registry
No

Interventions

  • OtherFollow 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

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 2513902 ↗
  • 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. PubMed 17230481 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jun 2024; primary completion for Jun 2025, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 5, 2024
First posted
Feb 13, 2024
StartEst.
Jun 1, 2024
Primary completionEst.
Jun 1, 2025
CompletionEst.
Aug 1, 2025
Last update
Feb 13, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06256471
Lead sponsor
Assiut University
Responsible party
Monica Refaat Hakeem Saweries (Demonstrator, Assiut University) — Principal investigator
First posted
Feb 13, 2024
Start date
Jun 1, 2024 (estimated)
Primary completion
Jun 1, 2025 (estimated)
Completion
Aug 1, 2025 (estimated)
Last update
Feb 13, 2024

Study contacts

Monica Refaat, Demonstrator
Contact
Monicarefaat24@gmail.com
01093466250
Magda Mohamed, Professor Doctor
Contact
Magda.elnazer@med.aun.edu.eg
01143533100

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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