Actively Recruiting

Age: 18Years - 65Years
All Genders
NCT05357781

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

Led by Insel Gruppe AG, University Hospital Bern · Updated on 2026-05-01

106

Participants Needed

1

Research Sites

234 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Multiple Sclerosis following McDonald 2017-Criteria
  • Age 18-65 years
  • Stable MS disease at inclusion with no clinical relapse, no MRI activity, and stable disability within the last 12 months
  • Unchanged immunotherapy within the last 12 months
  • Expanded Disability Status Scale (EDSS) level less than 4 points indicating fully ambulatory patients
  • Capability of written informed consent
Not Eligible

You will not qualify if you...

  • Severe depression defined as Beck Depression Index-II (BDI-II) 29 points or higher or other established psychiatric diagnosis
  • Immunodeficiency other than hypogammaglobulinemia
  • Immunoglobulin replacement therapy or indication for immunoglobulin replacement therapy
  • Severe sleepiness defined as Epworth Sleepiness Scale (ESS) greater than 16 points
  • Fatigue aggravating factors such as liver, renal, or thyroid dysfunction, substance abuse, medication (tranquilizers, antiepileptics, psychopharmaceuticals), or chronic infectious diseases like hepatitis or HIV
  • Other neurodegenerative or autoimmune diseases
  • Patients unable to give written consent
  • Vulnerable patients such as children, pregnant women, and prisoners

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospital of Bern Inselspital

Bern, Canton of Bern, Switzerland, 3010

Actively Recruiting

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Research Team

L

Lara Diem, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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