Healthy Clinical Trial
Official title:
Open Label Controlled Trial of Gluten-Free Diet in Patients With Gluten-Sensitivity and Cerebellar Ataxia
This study will screen patients with cerebellar ataxia to check for antibodies that indicate
allergy to gluten (wheat protein) and will study the effect of a gluten-free diet in
patients with these antibodies. Patients with cerebellar ataxia have problems with
coordination, resulting in "clumsiness" and unsteadiness of posture and walking.
There are many known causes of cerebellar ataxia, but in many patients the cause is unknown
and there are no available treatments. Cerebellar ataxia has been recognized as a
complication of celiac disease, a syndrome characterized by sensitivity to gluten.
Recognizing gluten sensitivity in patients with cerebellar ataxia would be important for two
reasons: it would be one of the rare causes of the disease that are potentially treatable,
and it would identify patients at risk for developing gastrointestinal cancers, particularly
intestinal lymphoma.
Patients with cerebellar ataxia of known or unknown cause and normal healthy volunteers of
any age are eligible for this study.
All participants will have a medical history, physical examination, blood drawn (30
milliliters, or 2 tablespoons) to check for celiac disease antibodies, and possibly other
lab tests. This completes the participation of normal volunteers.
All patients will have magnetic resonance imaging (MRI) of the brain. This diagnostic tool
uses a strong magnetic field and radio waves instead of X-rays to show structural and
chemical changes in tissues. During the scanning, the patient lies on a table in a narrow
cylinder containing a magnetic field. He or she can speak with a staff member via an
intercom system at all times during the procedure. Scanning times vary from 20 minutes to 2
hours.
Patients who have celiac disease antibodies will have an upper gastrointestinal (GI)
endoscopy intestinal biopsy. For this procedure, a flexible tube is inserted into the mouth
and down the throat into the stomach and duodenum (the upper part of the small intestine),
where a small tissue sample is taken for microscopic examination. Patients with these
antibodies will be put on a gluten-free diet and will be followed at NIH every 3 months for
12 months. On the first visit, patients will have their ataxia evaluated using NINDS's
ataxia scale and will meet with a dietitian for instructions for a gluten-free diet. On the
second through fifth visits (after 3, 6, 9 and 12 months, respectively, on the gluten-free
diet), patients will have their ataxia evaluated, speak with a dietitian to assess their
nutritional status, weight, and compliance with the diet, and provide a blood sample for
celiac disease antibody testing.
At the completion of the study, patients may choose to continue or stop the gluten-free
diet. If the ataxia assessments show improvement, patients will be advised to continue the
gluten-free diet permanently.
Status | Completed |
Enrollment | 150 |
Est. completion date | December 2002 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
Patients with sporadic cerebellar ataxia of unknown etiology. CONTROL PATIENTS: Patients with genetically confirmed cerebellar ataxia (SCA1,2,3,6, and 7, Friedreich's ataxia) or cerebellar ataxia due to known cause (e.g., cerebellar infarct, cerebellar degeneration secondary to alcohol abuse). AGE AND SEX-MATCHED NORMAL SUBJECTS: With no neurological or psychiatric disease and no medical or family history of celiac disease. |
N/A
Country | Name | City | State |
---|---|---|---|
United States | National Institute of Neurological Disorders and Stroke (NINDS) | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Neurological Disorders and Stroke (NINDS) |
United States,
Bhatia KP, Brown P, Gregory R, Lennox GG, Manji H, Thompson PD, Ellison DW, Marsden CD. Progressive myoclonic ataxia associated with coeliac disease. The myoclonus is of cortical origin, but the pathology is in the cerebellum. Brain. 1995 Oct;118 ( Pt 5):1087-93. Review. — View Citation
Cooke WT, Smith WT. Neurological disorders associated with adult coeliac disease. Brain. 1966 Dec;89(4):683-722. — View Citation
Cooper BT, Holmes GK, Ferguson R, Cooke WT. Celiac disease and malignancy. Medicine (Baltimore). 1980 Jul;59(4):249-61. — View Citation
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