|

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

RECRUITINGSponsored by Insel Gruppe AG, University Hospital Bern
Actively Recruiting
SponsorInsel Gruppe AG, University Hospital Bern
Started2022-07-01
Est. completion2026-12-30
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted

Summary

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.

Eligibility

Age: 18 Years – 65 YearsHealthy volunteers accepted
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

Conditions3

FatigueHypogammaglobulinemiaMultiple Sclerosis

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.