The Effect of a Gluten Free Diet on the Permeability of the Blood Brai

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

CompletedNot a drug-phase studyEarly (CIS/RIS)NCT03451955

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

This trial finished 4 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Gluten-free diet

What it measured

Main measures

  • Permeability of the blood brain barrier

    Change from baseline at 6 months

    MRI lesionsBlood or spinal fluid markers

Other measures (9)

  • Intestinal permeability

    Change from baseline at 6 months

  • Intestinal absorption capacity

    Change from baseline at 6 months

  • Counts of T cell subpopulations in peripheral blood and CSF

    Change from baseline at 6 months

    Blood or spinal fluid markersImmune response

  • Macrophage activation in peripheral blood and CSF

    Change from baseline at 6 months

    Blood or spinal fluid markersImmune response

  • Neuroinflammation

    Change from baseline at 6 months

    Blood or spinal fluid markers

  • Bacterial translocation

    Change from baseline at 6 months

  • Osteopontin as a marker of disease activity in multiple sclerosis

    Change from baseline at 6 months

    Blood or spinal fluid markers

  • Enterocyte damage

    Change from baseline at 6 months

  • Gut microbiota profiling

    Change from baseline at 6 months

Who could take part

Early (CIS/RIS) · 18 to 59

Show the full criteria

Inclusion criteria

* 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 criteria

* 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

History

    1. Started

      Jan 2018

    2. Main results due

      Jun 2022

    3. Finished

      Jun 2022

    Assembled by software from public sources.