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AtaxiaNCT00692861

Autoimmunity in Neurologic Complications of Celiac Disease

An observational study of Ataxia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study, done in collaboration with Cornell University in New York, will explore the potential role of the body s immune response to gluten in ataxia. Celiac disease is an autoimmune disorder that is triggered by the ingestion of wheat gluten and related proteins in genetically susceptible individuals. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Ataxia
How many people
14 participants
Where
1 siteUnited States
Study dates
2 Jun 2008to 3 Jan 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • We plan to evaluate serum and blood from patients with gluten sensitivity (including both biopsy-proven CD, and biopsy-negative cases with high anti-gliadin antibody titer) accompanied by cerebellar ataxia. Serum samples will be acquired prior to initiation of a gluten-free diet. Therefore, several inclusion criteria exist based on the study group:
  • INCLUSION CRITERIA FOR PATIENTS WITH CD PLUS CEREBELLAR ATAXIA:
  • The patient meets criteria for CD based on the modified ESPGAN criteria
  • The patient has ataxia with or without neuropathy based on clinical evaluation
  • The patient is free from other neurological and psychiatric deficits
  • All other known causes for ataxia have been ruled out through routine clinical evaluations
Show all 22Show fewer
  • The patient is at least 18 years old and is willing to participate in the protocol
  • The patient is not taking medications that are commonly known to have immune modulating effects.
  • The patient is not on a gluten free diet
  • INCLUSION CRITERIA FOR PATIENTS WITH HEREDITARY CEREBELLAR ATAXIA WITHOUT CD:
  • The patient tested negative for serologic markers of CD (i.e. antigliadin, antireticulin, and antiendomysial antibody testing as performed under protocol 93-N-0202)
  • The patient has ataxia on routine clinical examination and no other neurological or psychiatric problems
  • The patient has a known autosomal dominant ataxia (i.e., SCA, DRPLA, Friedreich s ataxia, and etc).
  • They should not have CD and or ataxia based on clinical evaluation and history
  • Serologic testing for antigliadin, antireticulin, and antiendomysial antibodies should reveal negative results
  • They should be race and age-matched with patients with CD and the ataxia group.
  • They should have no neurological or psychiatric conditions based on clinical evaluation and history
  • They should not have any rheumatological or autoimmune conditions in them or in their first degree relatives.
  • They should be at least 18 years of age and be able to provide consent for participation
  • They should not be on any immune modulating medications.
  • Final diagnosis of CD will strictly follow the modified criteria of the European Society for Pediatric Gastroenterology and Nutrition (ESPGAN) and recommendations of the recently held National Institutes of Health Consensus Development Conference on Celiac Disease. Assessment and diagnosis of cerebellar ataxia will be made by magnetic resonance imaging of the brain, clinical examination and genetic testing for spinocerebellar ataxias and Friedreich s ataxia. Additional routine testing will be done if necessary to exclude other causes.
  • Healthy and disease control groups will be evaluated for CD and for neurological deficits. Only symptom-free, antibody-negative individuals will be recruited into these control groups. Exclusion of neurological deficits and psychiatric illness in healthy and disease control subjects will be by history and neurological examination.

Who cannot join

  • For all groups, if other neurological and psychiatric diagnoses are present, the individual will not qualify to participate in this study.
  • Subject is already on a gluten-restricted diet.
  • Is taking known immune modulating therapy
  • Have other neurological condition (except for neuropathy) or psychiatric condition
  • Not willing to have blood drawn
  • Is known to have immune dysfunction
  • Being pregnant leads to numerous physiological changes. It is unclear if antibody characteristics are influenced by these changes.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cornell University

    New York, New York, 10021-4872

Other trials in United States

About this study

Official title: The Role of Autoimmunity in Neurologic Complications of Celiac Disease

This study, done in collaboration with Cornell University in New York, will explore the potential role of the body s immune response to gluten in ataxia. Celiac disease is an autoimmune disorder that is triggered by the ingestion of wheat gluten and related proteins in genetically susceptible individuals. Some people with celiac disease also develop ataxia, which is a loss of muscle coordination, leading to imbalance. The cause of the associated ataxia is not well understood, but it is suspected to be related to the immune response towards gluten in these patients. Preliminary results indicate that antibodies in people with celiac disease can react with brain proteins, which might have a role in the associated neurologic deficits. The aim of this study is to characterize the immune response in the ataxia that is associated with celiac disease.

People 18 years of age and older with 1) ataxia and no celiac disease, 2) ataxia plus celiac disease and 3) matched healthy control subjects will be enrolled at the NIH. People with celiac disease only will be enrolled at Cornell University.

All participants have a blood sample drawn for various tests of immune function as well as genetic tests. Healthy volunteers also have a history and physical examination if they have not had one done at NIH in the past year. Some patients may require additional clinical evaluations for clinical or diagnostic reasons.

Read the detailed description

Objective: To understand the role of the immune system in the neurologic complications of celiac disease (CD) or gluten sensitivity (GS).

Study population: We plan to study 15 patients with CD and ataxia, 15 patients with hereditary ataxia, and 30 healthy matched controls.

Design: Four groups of patients will be enrolled into the study. The first group will consist of patients with CD and ataxia, the second group will consist of CD patients without neurological manifestations, the third group will consist of patients with hereditary cerebellar ataxia without CD, and the final group will consist of healthy 30 race matched volunteers. The second group will not be recruited at the NIH. Standardized enzyme-linked immunosorbent assay (ELISA) techniques will used to assess the presence of synapsin I in the groups of patients. Using affinity assays, cross-reactivity of antibodies to gliadin and synapsin 1 will be evaluated. Antibody epitope mapping will be performed on those antibodies that cross-react with synapsin 1 and gliadin. HLA class II genotypic and phenotypic frequencies will be assessed and compared with the matched volunteers as an exploratory measure to look for genetic risk and protective factors in this group of patients.

Outcome measures: our outcome measures are as follows:

  1. To determine whether there is an association between antibody reactivity to synapsin I and neurological deficits of CD/GS.
  2. To characterize the cross-reactive antibodies in patients by determining subclass and affinity
  3. To map the epitope(s) of synapsin I that are targeted in patients with cross-reactive antibodies
  4. To explore HLA association in the subset of patients with CD and ataxia
Conditions
Ataxia
Keywords
Celiac Disease, Ataxia, Adults, Health Volunteer, HV
Medical subject headings
Ataxia, Celiac Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Antibodies to synapsin I.

Secondary outcomes (1)

  1. Antibody characterization and HLA association

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2008 (estimated)
  2. Study start2 Jun 2008
  3. Study completion3 Jan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00692861
Sponsor's protocol ID
080153
Other IDs
08-N-0153
Status last verified
3 Jan 2014
First submitted
5 Jun 2008
Last updated
16 Dec 2019
Results posted
No

Publications

  • Alaedini A, Green PH. Narrative review: celiac disease: understanding a complex autoimmune disorder. Ann Intern Med. 2005 Feb 15;142(4):289-98. doi: 10.7326/0003-4819-142-4-200502150-00011.

    PubMed 15710962

  • Fasano A, Berti I, Gerarduzzi T, Not T, Colletti RB, Drago S, Elitsur Y, Green PH, Guandalini S, Hill ID, Pietzak M, Ventura A, Thorpe M, Kryszak D, Fornaroli F, Wasserman SS, Murray JA, Horvath K. Prevalence of celiac disease in at-risk and not-at-risk groups in the United States: a large multicenter study. Arch Intern Med. 2003 Feb 10;163(3):286-92. doi: 10.1001/archinte.163.3.286.

    PubMed 12578508

  • Tommasini A, Not T, Kiren V, Baldas V, Santon D, Trevisiol C, Berti I, Neri E, Gerarduzzi T, Bruno I, Lenhardt A, Zamuner E, Spano A, Crovella S, Martellossi S, Torre G, Sblattero D, Marzari R, Bradbury A, Tamburlini G, Ventura A. Mass screening for coeliac disease using antihuman transglutaminase antibody assay. Arch Dis Child. 2004 Jun;89(6):512-5. doi: 10.1136/adc.2003.029603.

    PubMed 15155392

Questions about this trial

What is this clinical trial studying?

An observational study of Ataxia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Antibodies to synapsin I.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00692861, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2019.

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