NCT05357781 Immunoglobulin Deficiency a Treatable Cause of Fatigue in Patients With Multiple Sclerosis (MS)?
| NCT ID | NCT05357781 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Hypogammaglobulinemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 106 participants |
| Start Date | 2022-07-01 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 106 participants in total. It began in 2022-07-01 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Lara Diem, MD
PRINCIPAL INVESTIGATOR
Inselspital University Hospital of Bern
Frequently Asked Questions
Who can join the NCT05357781 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Hypogammaglobulinemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05357781 currently recruiting?
Yes, NCT05357781 is actively recruiting participants. Contact the research team at larafrancesca.diem@insel.ch for enrollment information.
Where is the NCT05357781 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT05357781 clinical trial?
NCT05357781 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Lara Diem, MD at Inselspital University Hospital of Bern. The trial plans to enroll 106 participants.