CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 103 enrolled
Drug / intervention
Gluten-free dietother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03451955
NCT03451955N/ACompleted

The Effect of a Gluten Free Diet on the Permeability of the Blood Brain Barrier in Patients With Clinically Isolated Syndrome Measured by Dynamic Contrast Enhanced Magnetic Resonance Imaging

University of Copenhagen·interventional·Posted Mar 2, 2018·Updated Dec 28, 2022

In Brief

A clinical study evaluating Gluten-free diet for Optic Neuritis and 2 related conditions. Completed, enrolled 103 participants across 2 sites.

Detailed 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 (GFD) for six months can contribute to normalizing BBB permeability in patients with newly diagnosed clinically isolated syndrome (CIS) and multiple sclerosis (MS). Furthermore, the study seeks to identify possible effects of a GFD on markers of systemic as well as CNS inflammation. Lastly, gut permeability is measured in order to examine whether there are any correlations between the permeability of the gut and the BBB as well as the inflammatory state in the intestine and CNS. From a patient's view, potential positive effects of a GFD will be manifested through an alleviation of symptoms, improved quality of life and reduced risk of CIS progressing to MS. Evaluating a possible role of gluten in MS pathogenesis can contribute to directing future research and optimizing treatment protocols.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMar 2, 2018
Enrollment StartJan 19, 2018
Primary CompletionJun 7, 2022
Study CompletionJun 16, 2022
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 8.3 years ago

Interventions

Gluten-free dietother

Participants in the intervention group abstain from gluten for 6 months.