NCT05357781
Immunoglobulin Deficiency a Treatable Cause of Fatigue in Patients With Multiple Sclerosis (MS)?
Recruiting · Not specified · Insel Gruppe AG, University Hospital Bern · registry updated 2026-05-01
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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
- 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.