Most of us are well aware that Alba Therapeutics (created to bring Dr. Fasano's anti-zonulin pills to market) is in the final stages of testing Larazotide Acetate in order to receive FDA approval for the product. So once again they are seeking test subjects for the latest trial. But look at the selection criteria for test subjects, especially the items that I have highlighted in red:
They are saying that subjects must have the symptoms of celiac disease, even though they are on a GF diet, but they can't have refractory celiac disesase. Well Doh! Either I don't understand the definition of "refractory", or somebody is playing games with the selection process.Eligibility
Ages Eligible for Study: 18 Years to 75 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria (select criteria, not all inclusive):
biopsy proven and serology-confirmed celiac disease (at any point in time prior to study entry)
written informed consent
age between 18-75
BMI between 18.5-40
symptoms despite being on a gluten-free diet (diarrhea, nausea, stomach pain, bloating)
must have attempted a gluten-free diet for at least 12 months
CeD-GSRS score
Exclusion Criteria (select criteria, not all-inclusive):
Refractory celiac disease
diagnosed with chronic active GI disease, such as irritable bowel syndrome, inflammatory bowel disease etc.
severe complications of celiac diseases
Just for a reality check, I decided to see how Webster defines the word "refractory":
So in view of that definition, it seems pretty clear that if we apply that definition to someone with celiac disease, a patient showing signs of a "refractory" condition would continue to show symptoms of the disease, such as "diarrhea, nausea, stomach pain, bloating", "despite being on a gluten-free diet".refractory adj., n., pl. ries. -adj. 1. hard or impossible to manage; stubbornly disobedient: a refractory child. 2. resisting ordinary methods of treatment. 3. difficult to fuse, reduce, or work, as an ore or metal. -n. 4. a material that retains its shape and composition even when heated to extreme temperatures. 5. refractories, bricks of various shapes used in lining furnaces
Are they taking out of both sides of their mouth at the same time, or am I nuts?
http://www.clinicaltrials.gov/ct2/show/ ... AUS&rank=2
The project must be continuing to encounter problems, because I see by the History of changes for the project that they have changed the recruitment criteria and a couple of other items again, almost a year after the recruitment announcement was first issued. Gee, I wonder if the convoluted recruitment criteria might have anything to do with that.
http://clinicaltrials.gov/archive/NCT01396213
In view of these weird selection criteria, how in the world could anyone in their right mind be expected to trust the results of the trial?
Tex
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