Status:
COMPLETED
The Effect of a Gluten Free Diet on the Permeability of the Blood Brain Barrier in Patients With CIS
Lead Sponsor:
University of Copenhagen
Collaborating Sponsors:
Rigshospitalet, Denmark
Conditions:
Optic Neuritis
Multiple Sclerosis
Eligibility:
All Genders
18-59 years
Phase:
NA
Brief Summary
Disruption of the blood brain barrier (BBB) is associated with inflammatory conditions of the central nervous system (CNS). This clinical trial aims to investigate whether following a gluten-free diet...
Detailed Description
Background: Disruption of the blood brain barrier (BBB) is believed to play a critical role in the pathogenesis of multiple sclerosis (MS). Cramer et al. (2014) found increased BBB permeability in MS...
Eligibility Criteria
Inclusion
- Adult men and women ≥18 and ≤59 years of age
- Patients with newly diagnosed CIS or MS deemed physically and mentally able to participate in a study
Exclusion
- More conflicting disorders in the same patient
- Pregnancy and lactating women and women planning pregnancy during the study period
- People with severe claustrophobia
- People with MR incompatible implants/ foreign objects, including implanted pacemakers, heart valve prostheses, prostheses in the middle ear, implanted devices (e.g. insulin pump), metal debris, e.g. metal splinters in the eyes, miscellaneous shunts and catheters, metal clips from operations
- Surgeries within the last 6 weeks
- Previous reactions to MR contrast agent, bronchial asthma or history of other allergies
- Elevated serum creatinine
- People already on a gluten restricted/ GFD
Key Trial Info
Start Date :
January 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2022
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT03451955
Start Date
January 19 2018
End Date
June 16 2022
Last Update
December 28 2022
Active Locations (2)
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1
University of Copenhagen
Copenhagen, Frederiksberg, Denmark, 1958
2
Rigshopitalet
Glostrup Municipality, Denmark, 2600