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NCT03451955
The Effect of a Gluten Free Diet on the Permeability of the Blood Brain Barrier in Patients With CIS
NA trial testing Gluten-free diet in Optic Neuritis in 103 participants. Completed in 16 June 2022.
7 June 2022
Quick facts
| Lead sponsor | University of Copenhagen |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 103 |
| Start date | 19 January 2018 |
| Primary completion | 7 June 2022 |
| Estimated completion | 16 June 2022 |
| Sites | 2 locations across Denmark |
Drugs / interventions tested
- Gluten-free diet
Conditions studied
- Optic Neuritis — all drugs for Optic Neuritis →
- Multiple Sclerosis — all drugs for Multiple Sclerosis →
- Clinically Isolated Syndrome — all drugs for Clinically Isolated Syndrome →
Sponsor
University of Copenhagen
Who can join
Adults 18 to 59, any sex, with Optic Neuritis or Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Detection of Dysbiosis and Increased Intestinal Permeability in Brazilian Patients with Relapsing-Remitting Multiple Sclerosis.
Pellizoni FP, Leite AZ, Rodrigues NC, Ubaiz MJ, et al · · 2021 · cited 32× · PMID 33925359 · DOI 10.3390/ijerph18094621 -
Nutrient Composition Comparison between the Low Saturated Fat Swank Diet for Multiple Sclerosis and Healthy U.S.-Style Eating Pattern.
Chenard CA, Rubenstein LM, Snetselaar LG, Wahls TL. · · 2019 · cited 8× · PMID 30871265 · DOI 10.3390/nu11030616 -
Cerebrospinal fluid neurofilament light chain in acute optic neuritis and its predictive ability of multiple sclerosis.
Passali M, Galea I, Knudsen MH, Lau LC, et al · · 2024 · cited 2× · PMID 39052040 · DOI 10.1007/s00415-024-12587-8 -
Blood-brain barrier permeability in relation to disease severity and timing of multiple sclerosis diagnosis in optic neuritis.
Passali M, Knudsen MH, Josefsen K, Antvorskov JC, et al · · 2025 · PMID 40520967 · DOI 10.1177/20552173251346979
Verify or expand the search:
- PubMed search for NCT03451955
- Europe PMC full search
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Related trials
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Trials testing the same drug.
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- NCT04006886 — Gluten-free Diet in Patients With Primary Sclerosing Cholangitis (PSC) · NA · completed
Other recruiting trials for Optic Neuritis
Currently open trials in the same condition.
- NCT07100990 — Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX) · Phase 3 · recruiting
- NCT06389968 — Light Stimulation to Improve Visual Function After Optic Neuritis in Persons with Multiple Sclerosis · NA · recruiting
- NCT05487989 — VIsual Pathways Model in Neuro-inflammatory Disorders · recruiting
- NCT05540262 — Edaravone in the Treatment of Optic Neuritis · NA · recruiting
- NCT05017142 — Swiss Pediatric Inflammatory Brain Disease Registry (Swiss-Ped-IBrainD) · recruiting
Other University of Copenhagen trials
Trials by the same sponsor.
- NCT07461324 — Surgeons' Prediction of Dental Surgery Complications and the Influence of Patient Characteristics: Development of an AI · not yet recruiting
- NCT07389421 — School Meals in Denmark · NA · not yet recruiting
- NCT07450690 — Exercise Training Effects on Muscle Function in Adults With Mitochondrial Myopathy · NA · recruiting
- NCT07302880 — The Acute Interference of Biotin in Blood Analysis · NA · not yet recruiting
- NCT07312981 — The CPH-MBD Cohort Dietary Substudy - Comparison of Methods for Dietary Registrations · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03451955 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Copenhagen
- Last refreshed: 28 December 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03451955.
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