Would You Eat Gluten for $160?

A very interesting email popped up in my inbox yesterday that got me angrier the more I read it. The University of Chicago Celiac Disease Center is recruiting patients for a clinical trial for a pill to treat celiac disease. I've said it before but I would never want to take a pill for celiac disease. I would rather pay attention to the food I am ingesting daily. I've been doing it for almost 35 years now so adding another medication to my body is of no interest to me! On the flip side, I do know many of my readers are interested in some kind of medication to manage celiac disease and might be willing to be in a clinical trial.

But this trial rubbed me the wrong way. If enrolled in the study, you need to eat gluten bread, go in for six study visits, have blood drawn, provide stool samples, and get an endoscopy in exchange for a whopping $160. Wait, what??? 

First of all, I would miss multiple days of work if I had to eat even one quarter of a slice of regular gluten bread. Traveling to and from the trial would become impossible unless I had a toilet nearby! I would also miss a full day of work for an endoscopy. That is approximately 3-4 days of missed work and is worth way more to me than $160.

Second of all, I don't believe there is not enough evidence about the long-term damage of eating even a little bit of gluten on someone with celiac disease. Have the trial coordinators considered this in their preparation?

Lastly, I would like to understand UPFRONT the way Montelukast will treat celiac disease and how symptoms will be monitored. According to the Mayo Clinic website, Montelukast has side effects that include: "abdominal or stomach pain, flu-like symptoms, general feeling of discomfort or illness, headache, joint pain, shortness of breath or troubled breathing, and unusual tiredness or weakness."
Sorry University of Chicago, but you won't get a clinical trial study out of me. I don't know about you, but I have at least two or three of these symptoms (if not all) every time I ingest gluten. NO THANK YOU.

What do you think about this trial? Do you think you would participate? If not, why? I would love your comments below!

A Pill to Treat Celiac Disease?
Now enrolling patients to a clinical study! 

WHO: you may be eligible for this study if:

• You are age 18 and older
• You have celiac disease
• You have been on a gluten-free diet for at least one year
• You are willing to eat gluten (bread)

WHAT: testing of Montelukast (a drug that has been approved by the FDA for treatment of asthma) for the treatment of Celiac Disease

If enrolled, you will be given the drug or a placebo and asked to:

• Come to up to 6 study visits
• Have multiple blood draws, endoscopy with biopsy and brushings, and provide stool samples
• Answer some questions regarding your health

WHERE: University of Chicago Medical Center

Subjects will be reimbursed up to $160.00 if all visits are completed and will receive parking vouchers.



NOTE: This is the exact email I got about the trial. If you have questions, please contact the University of Chicago Celiac Disease Center directly. 

Refractory Celiac Disease Clicincal Trial Participants Needed

Do you have refractory celiac disease and not respond at all to a gluten-free diet? This medical trial might be for you. Please use the contact information below for more information.

The Mayo Clinic in Rochester, Minnesota is seeking individuals diagnosed with Refractory Celiac Disease.

While most people can treat celiac disease with a strict gluten-free diet, a small number of patients fail to respond to a gluten-free diet and continue to have significant and severe symptoms. This is called refractory celiac disease and can increase the risk of mortality and developing lymphoma.

• Currently, there are no established treatments for refractory celiac disease 
• The goal is to study a new treatment for refractory celiac disease 
• The drug targets the effects of a signal (IL-15) in the body that is believed to cause much of the damage in the intestine
• It is hoped that this drug will lessen the damage in the intestine and/or lessen the severity of refractory celiac disease 
• The study involves multiple trips to Mayo Clinic in Rochester, Minnesota; Travel and lodging expenses qualify for reimbursement for required visits 

If you are interested or want more information, please contact: Carol Van Dyke by telephone at (507)-266-7842 or email Vandyke.Carol@Mayo.edu.

Source: Beyond Celiac

International Clinical Trials Day

Today is International Clinical Trials Day. Clinical trials are a critical part of healthcare research and development across the globe. These trials can include testing treatments, new medications, and new approaches to healthcare in humans. There is a tremendous amount of research involved with getting a new medication approved by the FDA and people who sign up for clinical trials are a vital part of this process.

While I have been part of focus groups and online surveys, I have never personally participated in a clinical trial. Recently, I learned about CureClick through the WEGOHealth advocacy community. CureClick is an interesting new web portal that shares information about clinical trials in general as well as including information about recruitment for active clinical trials. I learned a lot about clinical trials from this website and it helped me understand how, as patients, we can help inform our own medical futures. According to CureClick "Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research."

To my knowledge, there are a few clinical trials specifically aimed at finding a medicinal aid to those of us living with Celiac Disease; CureClick just doesn't list them yet. The good news is that I am CureClick Advisory Board Member and I have a lot of communication with the founders of the website. I have already asked them to share any celiac-related trials with me immediately which I will then pass along to you. Right now, CureClick is currently recruiting for trials about severe asthma,  mild/moderate asthma, high cholesterol and risk factors for heart disease, and Type 2 diabetes.

Many people are excited about the possibility of drug therapy for celiac disease. Personally, I do not know if I would ever take a pill for celiac treatment but it is nice for others to have options. I am happy to see medical researches even paying attention to Celiac Disease. It is empowering to think that participating in a celiac disease clinical trial can help shape the medical future of our disease.

Please visit CureClick.com for more information about clinical trials and learn more today! Stay tuned to Gluten-Free Fun for any celiac disease trial announcements. You will be the first to know as soon as I do!