Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006492
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-11-09
Brief Title:
Gluten-Free Diet in Patients With Gluten Sensitivity and Cerebellar Ataxia
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Open Label Controlled Trial of Gluten-Free Diet in Patients With Gluten-Sensitivity and Cerebellar Ataxia
Status:
COMPLETED
Status Verified Date:
2002-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 NINDSs 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
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 NINDSs 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
Detailed Description:
In many patients with cerebellar ataxia the etiology is unknown Sensitivity to gluten wheat protein has been suggested as a cause for cerebellar ataxia even in the absence of malabsorption symptoms or intestinal pathology However the prevalence of gluten sensitivity in patients presenting with cerebellar ataxia is unknown and the effect of gluten-free diet on gluten sensitivity-associated cerebellar ataxia has not been systematically studied The aim of this project is 1 To identify gluten sensitive cerebellar ataxia patients attending the Human Motor Control Clinic at the NIH using tests for celiac disease antibodies as a screening method 2 To conduct open-label controlled clinical trial to assess the efficacy of gluten-free diet in the patients identified using a detailed cerebellar ataxia scale as an objective clinical measure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-N-0003 | None | None | None |