There are several clinical trials going on.

ALV003 and Latiglutenase are designed to break down gluten before it can cause damage in the small intestine.

Larazotide Acetate is designed to mitigate symptoms from gluten ingestion.

TAK-101 and VTP-1000 are designed to get the immune system to tolerate gluten.

A couple of more too, but I need to update my research.  I’ll share information over the next few days.

When I evaluate whether to participate in a clinical trial, I think about a few things.

Is the study observational or a drug trial?  Observational just means they are gathering information and there is no drug intervention.  

The length of time the trial will take.  Most drug trials last a year or longer and that’s okay. Observational studies might be one day or several years.  I’m in an observational study. It has been going on for 5 years. It is expected to finish at year 10!

Does the trial involve an endoscopy at the beginning and end of the study period?  I typically don’t want to participate without endoscopy.  Researchers can’t really know the damage in my small intestine without an endoscopy.

What is the gluten exposure timeline and dosage?  The FDA has mandated at least a small amount of gluten exposure to challenge the drug.  The gluten challenge part is probably the scariest of all.  When evaluating the study, talk about what happens if you have symptoms and what are the rescue protocols.  

Does the trial have a “crossover” period? In a drug trial, “crossover” means you will eventually get the drug. It does not matter if you initially receive a placebo or the drug. You are guaranteed this outcome. I think this is vital. You don’t want to spend all this time only to find out you were on placebo the whole time.

How close is this trial to home?  If it is far, are there travel reimbursements and potential for home visits?  Close to home is best, just in case something goes wrong. 

Couple of other things – make sure to read the informed consent, get a timeline for visits, understand the compensation for your time, and talk to your family.

I think participation in a clinical trial is important to advance celiac research.  Please consider a trial that works for you and your family.