Celi Study Experience

Hi Marian,

     I am happy to share my experience as I love to contribute to the Celiac community.  For the most part I don’t have any privacy issues etc.  Just ask and I will let you know

  First let me share why I love this study:

1.  The medication is actually an enzyme

2.  The study does not ask that you go off the gluten free diet!

3.  The study helps you track your symptoms!

4.  You get free lab work and an EGD (something I have been intending on having done; however, I have had other medical expenses due to foot surgery and I have had to put off).

The study itself is handled in phases and you qualify phase by phase.

The initial phase is an extensive medical history – typical questions that you would have on a questionnaire for a physical.  Then you are asked about your historical intestinal issues, rashes, medication/alcohol use.  Nothing really earth shattering.  Your height, weight, & blood pressure are taken and you have a brief visit with the physician if any clarification is required.  My original biopsy noted that I had intraepithelial gastritis and I thought it may disqualify me from the study and the study coordinator wondered as well.  I believe that was the only reason I met with the doctor.  Oh, and there were consents to read & sign.  I was there 2 1/2 to 3 hrs. and I imagine I will not be there this long for each visit.

The study coordinators were very nice and I felt quite comfortable.  Sonia Collins is kind and very helpful/involved with the Celiac community (although not Celiac).  Sonia also likes the baked goods she receives from the patients to try!  Sonia is also more than willing to share new product information between patients.  Dr. Ennis was quite pleasant as well.  Dr. Ennis family is completely gluten free as his son has Celiac Disease (I always like to see that kind of support).

The next phase of the study was going over the lab results, the diary, & scheduling the EGD (which may be cancelled if I don’t qualify for the next round).  They performed all the labs I was looking for  When I was diagnosed, my doctor bypassed all the important stuff and went straight to the biopsy and the genetic testing (therefore, this was great).  The tests revealed that I was definitely negative for gluten – with the usual trace noted.  I am proud to say that I am very strict with my diet; however, I have a new deficiency:  Folate.  The doctor noted this as clinically significant and recommended a supplement (dually noted and purchased immediately). 

Next, we went over the daily diary.  For some reason I anticipated that it would be a food diary, but it is actually a symptom diary.  The idea of the study is that even someone like myself who is diligent with their gluten free diet is going to get a little gluten somewhere.  Therefore, cheating on your diet is not necessary, recommended, or required.  This initial diary will document the symptoms you have throughout the day.  The questions are related to symptoms you may have had throughout the day; diarrhea, regular bowel movements,  abdominal pain, bloating, nausea, or fatigue.  You go through a practice run with the study coordinator and then the next night you are on your own for 28 days.  I believe as long as you comply with the diary you qualify for the EGD.  The diary is really easy and it is by phone.  The company even sends you a text or will call you daily to remind you!  I was there for 45 min. and my next visit is actually my EGD (unless I fail at my diary and they cancel me).

If my EGD reveals I do not have any ongoing intestinal damage, I believe that will disqualify me moving forward.  Therefore, I may not have an update until the end of January as my EGD is not scheduled until January 24th.  Please feel free to inquire if you have any additional questions/concerns.