Screening Process; Gut Clinical Trial

I have never been involved with a clinical trial before so the process is interesting to me. Much paperwork and medical history discussions along w/ blood samples, urine, stool. Yeah - I said that - stool. Let me tell you how anxious I was driving 87+ miles with a cooler next to me of which inside was a container of 'poo'. Yea and don't even ask how fun it was to poo into a container rather than a toilet.... All in the name of science.

I was impressed by the doctor and the staff on their diligence for data integrity and the standardization of how they applied the clinical trial 'rules'. These rules caused scheduling future visits to be tricky. Apparently each visit and procedure must be done w/in so many days of the prior visit or procedure... After several changes we finally got it nailed down.... I worry about how much time I will be sacrificing away from work but excited that this trial might offer me proactive and effective treatment.

Then there is the 'Poo Diary' that I have to keep and fax in weekly. They have specific questions I have to answer on my poo and how I feel related to my crohn's.....This helps them score my baseline and also going forward to determine effectiveness of the treatment - provided I don't end up taking a placebo.... Although the doc says over 30% of people feel better due to placebo effect. Huh.

Next visit - the Colonoscopy... Fun fun. Soon after if all goes well I can begin taking the double blind portion of the trial where I either take the new treatment or placebo.

Lithia, FL
Tuesday, Oct 2, 2012