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Immunoglobulin Deficiency a Treatable Cause of Fatigue in Patients With Multiple Sclerosis (MS)?

Recruitingn/aAges 18 Years - 65 YearsAllInsel Gruppe AG, University Hospital Bern
NCT05357781 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The investigators hypothesize that hypogammaglobulinemia (defined as IgG serum concentration \<7.0g/L) is a treatable cause of fatigue in people with MS: The primary objective is to prove the link between hypogammaglobulinemia and fatigue in patients with multiple sclerosis. The secondary objective is to show that fatigue is mediated via frequent infections in people with MS and hypogammaglobulinemia.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Diagnosis of Multiple Sclerosis following McDonald 2017-Criteria * Age 18-65 years * Stable MS disease at inclusion (definition: no clinical relapse, no MRI activity, stable disability within the last 12 months) * Unchanged immunotherapy within the last 12 months * Expanded Disability Status Scale (EDSS) level \<4 points indicating fully ambulatory patients. * Capability of written informed consent Exclusion Criteria: * Severe depression (definition: Beck Depression Index-II (BDI-II) ≥29 points) or other established psychiatric diagnosis * Immunodeficiency other than hypogammaglobulinemia * Immunglobulin replacement therapy or indication for immunoglobulin replacement therapy * Severe Sleepiness (definition: Epworth-Sleepiness-Scale (ESS) \>16 points) * Fatigue aggravating factors such: liver/renal/thyroid dysfunction, substance abuse, medication (tranquilizers /antiepileptics/psychopharmaceuticals), chronic infectious disease (like hepatitis/HIV). * Other neurodegenerative/autoimmune disease. * Patients not able to give written consent * Vulnerable patients such as children, pregnant women and prisoners
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What it tests

  • Laboratory test
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Where

1 site
University Hospital of Bern Inselspital
Bern, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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