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| Sponsor: | Georgetown University |
|---|---|
| Collaborators: |
National Institute of Environmental Health Sciences (NIEHS) University of South Alabama |
| Information provided by: | Georgetown University |
| ClinicalTrials.gov Identifier: | NCT00810329 |
Purpose
The purpose of this study is:
| Condition |
|---|
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Chronic Fatigue Syndrome Fibromyalgia Gulf War Illness Multiple Chemical Sensitivity Interstitial Cystitis Irritable Bowel Syndrome |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Identify Unique Set of Proteins in Cerebrospinal Fluid, Which Are Believed to be Found in Chronic Fatigue Syndrome Participants, But Not in Healthy Controls. |
Cheek swabs, on the right and left inner cheek. Others:Cerebrospinal fluid samples,Blood samples Urine samples.
| Estimated Enrollment: | 150 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | April 2011 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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1
This group consists of patients with Chronic fatigue syndrome, Fibromyalgia and other conditions like Multiple chemical sensitivity, Irritable bowel syndrome, Interstitial Cystitis, Gulf War Illness.
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2
The healthy control group
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Neurological dysfunction is a key component of the clinical expression and case designation of chronic fatigue syndrome (CFS), fibromyalgia (FM)and other related conditions.If the central nervous system is involved, then evidence will be present in the cerebrospinal fluid. Distinct patterns of proteins will be present in Chronic fatigue syndrome (CFS) compared to healthy control (HC) subjects.
Other testing in our study would include:
Skin tests like:
i) Capsaicin skin test, to check for specific responses like burning sensation, area of skin redness, itchy sensation to varying doses of capsaicin (essence of chilli pepper), when placed on the forearm and to compare if there are any differences seen between the responses in CFS and Healthy controls.
ii) Allergy skin test to look if there are any allergies that are seen in the set of CFS population.
Eligibility| Ages Eligible for Study: | 21 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Murugan K Ravindran, MBBS | 202-687-8231 | cfsresearch@georgetown.edu, look4murugan@gmail.com, mkr33@georgetown.edu |
| Contact: Yin Zheng, MS | 202-687-8231 | gwiresearch@georgetown.edu |
| United States, District of Columbia | |
| Georgetown University Hospital, 3800 Reservoir Rd NW | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Contact: Murugan K Ravindran, MD 202-687-8231 look4murugan@gmail.com | |
| Principal Investigator: James N Baraniuk, MD | |
| Sub-Investigator: Hilda Maibach | |
| Sub-Investigator: Vance Watson, MD | |
| Sub-Investigator: . Fraser C Henderson, MD | |
| Sub-Investigator: Cristina Di Poto, Ph.D | |
| Sub-Investigator: Habtom Ressom, Ph.D | |
| Sub-Investigator: Lewis Pannell, Ph.D | |
| Sub-Investigator: Peter Burbelo, Ph.D | |
| Principal Investigator: | James N Baraniuk, MD | Georgetown University Hospital |
More Information
| Responsible Party: | Georgetown University Medical Center ( James N Baraniuk MD, Associate Professor of Medicine ) |
| Study ID Numbers: | 2006-481, RO1 ES015382 |
| Study First Received: | December 17, 2008 |
| Last Updated: | February 1, 2010 |
| ClinicalTrials.gov Identifier: | NCT00810329 History of Changes |
| Health Authority: | United States: Federal Government |
|
CFS,FM,CSF,Proteomics,Pain,Fatigue,GWI,IBS,IC,MCS. |
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Gastrointestinal Diseases Colonic Diseases Disorders of Environmental Origin Encephalomyelitis Fatigue Syndrome, Chronic Signs and Symptoms Hypersensitivity Pathologic Processes Urologic Diseases Musculoskeletal Diseases Neuromuscular Diseases Syndrome Irritable Bowel Syndrome Environmental Illness Multiple Chemical Sensitivity |
Disease Fatigue Immune System Diseases Myofascial Pain Syndromes Fibromyalgia Urinary Bladder Diseases Nervous System Diseases Cystitis Central Nervous System Diseases Rheumatic Diseases Intestinal Diseases Virus Diseases Cystitis, Interstitial Muscular Diseases Digestive System Diseases |