Have you ever been eating your cereal in the morning and look down at the box to see 3-4 letter symbols in colored circles?  I have and wondered what those meant-only to look at the ingredient list to see they stand for certain ingredients either included in the product or free from the product.  This includes Gluten the protein found in wheat, barley and rye that people with Celiac disease are allergic to.  When I was researching Celiac Disease and Gluten, I came across many sites for “gluten free diets” and how to follow them.  Some were from Celiac disease suffers and others were just people trying to make a buck on the latest get thin quick scheme.  But what I also saw was several Celiac Disease suffers who were stating how difficult it is to truly live gluten free because of the lax rules surrounding this very label.  So I did a little digging.  According to the FDA website http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm265212.htm, they are opening up discussions about tightening the rules needed for manufactures to produce foods with this label (a discussion originally started 4 years ago in 2007).  As it stands right now, it is up to the manufactures to decide if the product is gluten free or not. 
Which means one food could have less than a 100 parts per million of gluten in it and be labeled gluten free (at this amount most Celiac suffers would have symptoms) verses another food that has less that 20 parts per million
of gluten (below this it becomes undetectable) which most Celiac disease suffers can tolerate.  

Fine, you think, if it is that difficult, the sufferer can just avoid any product made with a grain. Not so easy as sometimes a product that seems gluten free may have gluten in it because it is manufactured in a plant that produces gluten laden products therefore there is cross-contamination. Although many foods contain gluten, it is not always included in ingredients lists. This lack of inclusion is because gluten is not used in the formulation of the product, but use in the manufacturing of the product. One example is the dusting of the conveyor belts in the production facilities with gluten products to prevent the foods from sticking during processing. "Natural
Flavoring" is also suspected to contain gluten. This type of gluten contamination may not be labeled; information confirming whether this form of gluten is present in a given product may only be available by contacting the
food manufacturer directly. One example of this was an independent study done on a chicken nugget sold by Wellshire Farms.  In an investigation reported by the Chicago Tribune on November 21, 2008, Wellshire Farms chicken nuggets labeled "gluten-free" were purchased and samples were sent to a food allergy lab at the University of Nebraska. Results of the testing indicated gluten was present in levels exceeding 2,000 ppm. After the article was published, the products continued to be sold.  However, after receiving customer inquiries, Whole Foods Market removed the product from their shelves over a month later. Wellshire Farms has since replaced the batter used in their chicken nuggets. (http://en.wikipedia.org/wiki/Gluten-free_diet).

Plenty of people without celiac disease have embraced these products, believing that avoiding gluten will help them lose weight, improve their mood, or increase their energy. Last year, sales of gluten-free products hit $1.2 billion; more than double the sales from 2005.  If a person is not afflicted with celiac disease then avoiding gluten
will not help them.  However, by avoiding gluten (cookies, cake, and breads) people may feel better and lose
weight because they are replacing them with fruits and vegetables which is a healthier diet.

If you are a Celiac Disease suffer, your task is that much harder.  Hopefully the FDA regulations will soon be changing as they are currently being reviewed.  Also, new medications are being developed to prevent those glutens that sneaking through your gut into the blood stream.  We will be conducting a study starting in late January for a medication that helps to decrease the leaky gut that allows gluten to pass through the intestine into the blood, therefore hopefully eliminating those break-through attacks.  Stay tuned to our website for details and contact us if you are interested in being a part of this study! 
   

We are ramping up for a new study for people with Diagnosed Celiac disease which is also called "sprue".  It should be a great study as this is a disease of the immune system that affects more than 3 million people in the USA!  As with any new study, I try to do my research so I am up to date on the disease in question and during my reading it was referred to as Sprue but nowhere in the literature was it explained why.  So like all good researchers with a question, I GOOGLED it!  Funny thing was, I found lots of articles about the disease and the gluten free diet sufferers must follow but nothing about why it is called sprue!  I also found the definition of sprue which is a manufacturing term meaning the channels used to pour liquid metal into a mold.  Ok, I thought, what does that have to do with a small intestine disease that causes its victims to become malnourished?!  After much searching, I learned a lot about the disease and finally found out how it became to be known as Sprue.  Here's what I learned:

1.  Explanation of the condition:  Celiac Disease (Sprue) causes damage to the lining of the small intestine by damaging villi (tiny absorption hair like structures in the lining of the intestine) and prevents them from absorbing nutrients/food essentials that keep us healthy.

2.  Why it happens:  The damage occurs when the individual affected eats something containing gluten (a protein found in wheat and related grains such as rye and barley).  The person's own immune system that damages the villi as it reacts to the gluten because it thinks the gluten is a threat to the body (like a virus or parasite) and tries to kill it. 

3.  Who is affected:  The cause of why this starts is unknown but with careful documentation, a few patterns have emerged.  First, the disease can affect any age and can go undiagnosed depending on the severity of symptoms.  It does however run in families so if someone in your family has it you are more likely to have it too.  It also affects more women than men which is common in most autoimmune diseases.  It also affects more Caucasians and those of European decent.

4.  Found more often with other common diseases: People who have the following disease are also more likely to have Sprue: Diabetes type 1 (insulin dependent), Autoimmune disorders (RA, Lupus), Addison Disease (President Kennedy had this), Down's Syndrome, Intestinal Cancers, Lactose Intolerance, and Thyroid disease.

5.  Last but not least after much digging, why Celiac Disease is called Sprue!  It was first described by Dr. William Hillary in 1759 while he was in Barbados.  The European settlers who came to these lands were afflicted by this disease that caused severe diarrhea and is now called Tropical Sprue.  The Tropical version is caused by an infection where Gluten Sprue is not.  The description of the disease we now call Sprue was actually described by Dr. Ketelaer, a Dutch physician, in 1669 but was called Sprouw (scholars think Dr. Hillary translated this into an English version of the word for "Sprue").  He observed a wasting illness with diarrhea in Holland which now is thought to be the first documentation of the Gluten reaction we now know as Celiac disease/Sprue.

So there you have it-took a lot of digging to understand why this strange word is associated with the disease but you can win a lot of money on Jeopardy if it is a final question!  This looks to be an interesting study and with 1 in every 133 people affected by Celiac disease, it can also be very helpful to a lot of people!  Are you affected by this disease or know someone who is?  Is it hard to follow a Gluten free diet?  My next blog will be taking about the gluten free diet and what all those symbols on Wegman's products mean!
Stay tuned for that Blog and to our current study listing for the description of the study and admission criteria very soon!!!

When I have approached practice patients, friends, and people at a support group about participating in a research study many have asked-"why should I participate? Aren't I just being a guinea pig"? I thought my first blog entry should answer this question as it is the basis of why we conduct studies.  I have spoken to 2 of our Investigators about these questions and they had 2 different but important responses.  First, Dr. John Condemi explained to me that we have to think about our genetic makeup and how race plays a part.  Every race of people have different reactions to different substances.  As Americans, we are unique in our genetic makeup from Japanese, Mexican, even European races.  Studies are performed around the world to make sure the medication meets each country’s standards.  Medication may work differently on different races of people. If, for instance, a medication is tested in Japan, the results obtained in Japan may differ from the results in India or America.  The only way to know if a medication is safe and effective on Americans, is to test it on Americans.
Secondly, It is very important to find out any possible side effects of a medication during its testing phase.  
All side effects must be considered during the drug approval process. Dr. Deane explains that in some countries, a person’s only access to medication may be a clinical trial. They may not report a side effect for fear they will be discontinued from
the study and receive no medication for their condition. For the majority of Americans, this isn’t the case and side effects get reported.  It is important for Americans to participate in clinical trials and report all side effects so the
FDA can make an informed decision on whether a drug is safe for Americans to use.
Both reasons are equally important to urge Americans like you and me to participate in clinical trials right here in the states where the procedures are closely monitored by competent and caring doctors and nurses so medication that come to market can be safely used by our patients, friends, and family.