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Neurocoeliac disease: Prevalence, diagnosis, treatment and follow up

Neurocoeliac disease: Prevalence, diagnosis, treatment and follow up - Neurocoeliac disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON47970
Enrollment
200
Registered
2019-04-26
Start date
2019-08-04
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gluten ataxia neurocoeliac disease

Interventions

None listed

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - * 18 years of age - Given informed consent - unexplained ataxia - Group specific: o For gluten sensitivity group: at least positive serology or borderline positive serology o For coeliac disease group: positive serology and positive biopsy results

Exclusion criteria

Exclusion criteria: - No informed consent - Insufficient knowledge of Dutch language and/or inability to understand the information provided. - A known and verified cause of the neurological illness - For MRI specific: Because of the high magnetic field of the MRI scanner, individuals with pacemakers, metallic implants, pregnancy, or certain other conditions (for example a bodyweight over a 140kg) should be excluded unless they are cleared by a clinical radiologist/physiologist.

Design outcomes

Primary

MeasureTime frame
The main study endpoint will be the prevalence of (neuro)coeliac disease related antibody titres in the neurology cohorts, together with the HLA-DQ type and the Marsh classification based on a gastroduodenal biopsy (only if a biopsy has been performed as standard care).

Secondary

MeasureTime frame
Secondary endpoints will be the effect of a gluten-free diet on antibody titres, neurological symptoms, quality of life and MRI and MR spectroscopy results in patients suspected of gluten ataxia.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)