Exploring the link between immunoglobulin deficiency and fatigue in multiple sclerosis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate whether hypogammaglobulinemia, characterized by low IgG serum levels, is a treatable cause of fatigue in patients with multiple sclerosis (MS). The primary objective is to establish a connection between hypogammaglobulinemia and fatigue, while the secondary objective focuses on understanding if fatigue is exacerbated by frequent infections in these patients. The study will involve laboratory tests to assess immunoglobulin levels in individuals diagnosed with MS who meet specific inclusion criteria. By identifying potential treatable factors contributing to fatigue, the study seeks to improve the quality of life for MS patients.

Why it matters

Who can join: the full rules

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

Where it's running

• University Hospital of Bern Inselspital
  Bern, Canton of Bern, Switzerland Recruiting

Study contacts

• Principal investigator: Lara Diem, MD — Inselspital University Hospital of Bern
• Study coordinator: Lara Diem, MD
• Email: larafrancesca.diem@insel.ch
• Phone: 0041316327000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.