Clinical Trial 41897

New York, NY 10021


Summary:

Study 41897 Flyer
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We are examining the effects of a small amount of exercise on inflammatory molecules in the blood and gut of both Chronic Fatigue Syndrome (CFS) patients and in gender and age matched normal controls to better understand the underlying pathophysiology of this disease .  This study is part of an NIH funded effort to study  CFS under the auspices of the Center for Infection and Immunity at Columbia's Mailman School of Public Health with Ian Lipkin, MD as the principal investigator.  Please see attached flyer: in brief control participants will be screened with brief questionnaire, blood for basic chemistries and CBC and sign a consent form and will be provided with a large but lightweight box to take home or to work with them that day in which they will provide a future stool specimen.  After passing the screening the control subject will be contacted by a research assistant who will schedule them on a Monday/Tues or Wed/Tues at either 9 or 11 am time slot (for 1/2 hour each day) to undergo short treadmill test.  If, for instance, they are scheduled for Mo/Tues time slot at 9 am they will produce a stool specimen the night before (Sunday) and be given instructions on how to refrigerate it in packaging provided during the screening visit; they will get round trip paid car service vouchers that allow them to travel to Columbia at 168th Street and they would call to schedule a pickup at home at 8 to 8:30 so they will arrive in time and bring stool specimen.  They will perform treadmill exercise and be given another box to provide `post exercise stool specimen' and return to Columbia using same car service the following day.  The subject will be fasting from midnight on on both days and will receive $ 250 check at the end of the procedure.



We are searching for `fit' individuals who may have other mild disease conditions like controlled hypothyroidism and mild anxiety or depression but who have not had cancer within the last five years, any inflammatory disorders such as rheumatoid arthritis; active infections, such as tuberculosis and uncontrolled moderate to severe hypertension, coronary artery disease or arrhythmias, and who have not been on antibiotics for 3 months prior to enrolling in the study.   Participants will receive paid round trip car service to Columbia at 168th street if they reside within 5 boroughs; if they live outside this radius they must provide their own trasnportation.  Participants should agree to come to east side location at private office from 9 am to noon on any weekday to sign a consent form; have bloodwork done that will test for anemia, hepatitis, diabetes and thyroid function; and then carry a large but lightweight box home or to work that day which will be necessary for collection of the pre exercise stool specimen as described in study summary.  Also, control subjects must be willing to fast from midnight on and hold medications until after the study is completed when they arrive at Columbia.  At this time we are searching for the following: 

2 white male control subjects aged 46 to 56; 1 African American female aged 22 to 32; 1 white female aged 65 to 70.


Qualified Participants May Receive:

Participants who complete the study successfully will receive $ 250 check.


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.