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Two Celiac Disease Studies At Columbia University

2 Comments 14 April 2008

The Celiac Disease Center at Columbia University is currently seeking volunteers to participate in two clinical trials.

Can you help?

STUDY #1
Evaluating the effectiveness of an antibiotic (Rifaximin) in the amelioration of symptoms in patients with poorly responsive celiac disease.

To be eligible for this study you must meet the following inclusion criteria:

Men and women 18 years of age or older
Biopsy proven celiac disease
Persistent symptoms of one or all of the following: diarrhea, gas, bloating and cramps despite a gluten free diet of at least six month.

The study is approximately 12 weeks long and it involves 3 visits to our center.  If you are eligible you must remain gluten free for the duration of the study, you’ll be randomized as in the flip of a coin to either study drug or placebo (sugar pill). On each visit you will be tested for bacterial overgrowth with a simple breathtest and you?ll also complete a small gastrointestinal questionnaire to record symptoms.

If interested, please contact the research coordinator Maria Teresa Minaya @ 212-305-5422 or mtm2111@columbia.edu.

STUDY #2
Research Clinical trial to study the safety and effectiveness of a new study drug (AT- 1001) that may allow patients with celiac disease to ingest gluten.

To be eligible for this study you must meet the following inclusion criteria:

Men and women between the ages of 18- 72 inclusive
Biopsy proven celiac disease
Gluten free diet for at least six months
Willing to complete 7 study visits in a period of 10 weeks
You cannot have any chronic GI disease other than Celiac Disease
You cannot have diabetes
You cannot chronically consume non-steroidal anti-inflammatory agents (NSAIDS) such as Advil or Aleve or take drugs like Nexium.

Willingness to use an approved form of birth control (if required)

You must remain on your gluten-free diet for the duration of the study. You will be randomized (as in the flip of a coin) to either the study drug or drug placebo (sugar pill) and a pill containing gluten.  You will have a physical exam by the study doctor.  Blood and urine will be collected from you at each visit.  You will be asked to fast and collect your overnight urine before each study visit.  You will also answer weekly gastrointestinal and health questionnaires in an electronic (computer) diary that will be given to you while you participate in the study.
If interested, please contact the research coordinator Maria Teresa Minaya @ 212-305-5422 mtm2111@columbia.edu.

THANK YOU!

******
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Your Comments

2 Comments so far

  1. 1
     
    Justin G. says:

    Sweet. Let’s help beat this thing…!

  2. 2
     
    S A Malone says:

    I would be very interested in the results of these two trials. Unfortunately I live too far away to participate in them.


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Kelly Courson

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Thanks for stopping by! I'm Kelly Courson and this is where I've shared my gluten-free finds since 2003. The world has been my gluten-free oyster for 14 years now and I love sharing what I've learned in order to help others adapt to a gluten-free diet. Have a look around and feel free to leave a comment. Connecting with people like you is what has kept me going this long! Seriously.
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