Celiac Disease News: A Vaccine is in Phase I trials

New Drug is in Clinical Trials

Dr Robert Anderson, PhD from Australia announced that after several years of research his vaccine was ready for a Phase I trial. I remember meeting Dr Anderson a few years ago at a National Foundation for Celiac Awareness conference ,where he shared with me his goals about this research.

The study was composed of 34 celiacs, 19 people of whom received the vaccine while 15 received a placebo of saline water.

The participants followed a strict gluten-free diet and were of the DQ2 genotype (genetic profile) for celiac disease. DQ2 is the most commonly known gene for celiac and it is estimated that 80% of celiacs carry the gene.

The goal of the phase I trial was to assess the weekly injectable vaccine for safety, tolerability and efficacy. The vaccine is derived from wheat and barley and contains 3 peptides (or protein fragments) that commonly create an immune reaction.

What Were the Side Effects?

The side effects of the 19 people tested included:

GI distress, typically similar to that felt with inadvertent gluten ingestion.

One individual had to withdraw from the study because the digestive complaints were too severe.

7 out of the 19 suffered from nausea,

2 suffered from severe nausea and

2 others vomited shortly after receiving the injection.

The mechanism of the vaccine is to target the immune cells (T cells) that are specific for celiac disease and have them instead be created specifically against the vaccine. In turn these T cells, once specific immunity is developed, create an immune substance called gamma interferon, which is critical in developing a specific immunity. This mechanism would be similar to the one used in allergy shots where someone is desensitized to something they’ve been reacting to. The injections are designed to prevent the typical immune reaction of the offensive substance from occurring.

As a side note, gamma interferon, when aberrant, is associated with autoimmune disease, meaning the immune system gets overstimulated to a point where it starts attacking the body itself instead of the foreign agent.

Four out of Nineteen Participants Had a Positive Response

Only 4 of the 19 participants generated these desired type of T cells, although Dr Anderson seemed pleased with this response, since he considered the trial a success.

There are considered to be over 60 peptides (pieces of protein) that are responsible for the reactions against gluten. This vaccine includes only 3 peptides, but its creators feel that these account for the majority of the negative reactions that are seen.

As mentioned above, this particular vaccine is only applicable for those who carry the DQ2 genes. In regard to celiac disease, we know that patients with the gene DQ8 can also develop the disease and it is thought that many other genes are involved as well. DQ2 is the most prevalent so it definitely made sense that a gene specific vaccine would be created for it, but the vaccine would not be universally effective on all celiacs.

Of course this vaccine does nothing for those suffering from gluten sensitivity, who have a different genetic profile. But gluten sensitivity is a newer player in the gluten intolerance arena, so no big surprise that a vaccine would focus on those with celiac disease.

With 4 individuals out of 19 generating the desired T cell response, that puts the “success” rate at 21%. I personally wouldn’t consider that a success, but I’m often surprised at what is acceptable in the drug and vaccine field.

While the trial was considered successful, even if all goes according to plan there would not be a vaccine on the market before 2017.

So what are my personal conclusions?  From the science perspective I share Dr Anderson’s excitement in developing a mechanism that causes the immune system to react in the way he had envisioned it.

But from a clinical perspective I have concerns. There has never been a drug or vaccine with zero side effects and I’m sure this one, should it make it to market, will be no different. What will these side effects be and how long will the vaccine need to be on the market before they are realized? No one yet knows.

Is a 21% Positive Outcome Really Considered Effective?

The “effectiveness” according to this trial was 21% of those who received the vaccine. But remember that the vaccine is only appropriate for about 80% of the celiac population. With its current efficacy, a population of 100 people would only find 17 potentially benefiting from this vaccine, excluding any side effects.

With No Drug on the Market, What Should We Do in the Meantime?

So where does this leave us? No different really than we were before this data came out. The truth of the matter is, that at this point and likely for several years into the future, our goal must be timely diagnosis of celiac disease and gluten sensitivity, gluten elimination, and an effective program to heal the gut while reversing as much gluten-induced damage as possible.

This is what we specialize in at my clinic HealthNOW Medical Center. Since writing our book The Gluten Effect” we have come to realize the overwhelming demand for a clinic that would provide such a service. In response to that need we created a destination clinic so that we could see patients from across the country as well as internationally. This has been very successful and our destination clinic patients have enjoyed dramatically improved their health. 

Need Help? We're Here for You! 

If you felt as if I was describing you above, you are not alone. As I mentioned earlier, adrenal fatigue/exhaustion is almost epidemic. If you would like assistance and don’t have a clinician whom you feel can assist you, consider contacting us for a FREE Health Analysis. We are a Destination Clinic and treat patients from across the country and internationally. We would be delighted to help you as we have been doing so for over two decades.

Visit us at www.RootCauseMedicalClinic.com. If you have questions or need any help, I’m here for you! Call 408-733-0400.

I look forward to hearing from you.

To your good health,

Dr Vikki Petersen, DC, CCN, CFMP


IFM Certified Practitioner

Founder of Root Cause Medical Clinic
Co-author of “The Gluten Effect”

Author of the eBook: “Gluten Intolerance – What You Don’t Know May Be Killing You!”

Are There Degrees of Gluten Intolerance?

I recently saw an “Ask the Doctor” question on a popular news website. The individual's question involved degrees of gluten sensitivity. She already knew that she didn’t have celiac disease, but she wanted to know if gluten was still a problem for her.

Much of the data shared was accurate, but there was some misinformation presented also that I wanted to point out, so that you won’t be confused or misinformed.

To define our terms, I use 'gluten intolerance' as an umbrella term that embraces both celiac disease and gluten sensitivity.  Research into gluten sensitivity is still in its infancy. Just a few years ago, researchers were arguing whether or not the condition even existed, and today some major research dollars are being spent to understand it and diagnose it. While that is positive, we still have a long way to go.

Celiac disease is estimated to affect 1% of our population with that number increasing to 4% with age.

Gluten sensitivity is conservatively estimated to affect 10% of our population (remember the research is very young) which makes it an extremely common condition. Personally I believe that we’ll find gluten sensitivity to affect upwards of 30% of our population, but time will tell.

Unfortunately, this knowledge is not yet widely known among clinicians as evidenced by the woman who sent in her question. And I quote: “I know that I'm sensitive to carbs but I wanted to know how sensitive I was to gluten. I had a test taken by a nutritionist, and it came out positive. So I wanted to get tested by an official M.D., which I did. He tested me for celiac disease, even though I told him I didn't have it. He didn't understand when I told him that gluten sensitivity has different degrees of impact.”

All too often patients who suspect gluten intolerance are tested only for celiac disease. The poor sensitivity of the tests aside, (there are many false negatives) omitting a test for gluten sensitivity easily misses diagnosing millions of people who are suffering from the ill effects of gluten.

The doctor who wrote the answer apparently interviewed Dr Joseph Murray of the Mayo Clinic. Dr Murray is someone I respect highly, but I do have to disagree with some of the information that is attributed to him in this article. 

Before I mention my specific disagreements, I do want to note for the record that individuals are not always quoted correctly and this very well could have happened here. Just yesterday I had the same thing happen, when I saw a quote attributed to me on a website that was inaccurate.

Okay, let’s get on to what was said, what I disagree with and what the truth is in my opinion.

Dr Murray is quoted as calling one version of gluten sensitivity “celiac lite” and stating that the person doesn’t have the positive tests for celiac disease but has digestive symptoms that benefit from a gluten-free diet. He also states that non-celiac gluten sensitivity does exist but defines it the same as “celiac lite” and mentions that the patient is often diagnosed with irritable bowel syndrome or IBS.

My disagreements with the above are:

First, calling a condition that creates depression, migraines, obesity, fatigue, schizophrenia and pain ‘lite’ is insulting to those who suffer from it. None of the over 300 symptoms and conditions associated with gluten sensitivity are ‘lite’; they are serious and potentially life threatening. In fact in the Journal of the American Medical Association, fellow American researcher Dr Peter Green cites  Dr Ludvigsson’s findings from Sweden, that undiagnosed gluten sensitivity increases your mortality rate from all causes.

Relegating the symptoms associated with gluten sensitivity to only those associated with digestion is not only inaccurate but does a grave disservice to the concept of increasing awareness. The facts are that neurological symptoms from gluten outnumber digestive symptoms greatly. One of the biggest hurdles we have to surmount is overcoming the false idea that gluten only creates digestive complaints. This is one of the reasons that our diagnosis rate is so pitifully low (5%); doctors don’t think to check their patients for the condition.

Dr Murray apparently quoted a recent Australian study published in the American Journal of Gastroenterology whereby researchers acknowledged the existence of gluten sensitivity but were unable to determine its cause.

That may be the conclusion of those researchers, but we do know that gluten sensitivity results from the immune system reacting in a negative fashion towards gluten. It may not be the exact same reaction as is seen in celiac disease, as it appears to involve a different aspect of the immune system, but that makes it no less serious. The hundreds upon hundreds of patients that we have personally seen in our clinic whose health improvement was miraculous because we discovered them to be gluten sensitive, is truly vast. These patients did not have celiac disease but they were gluten sensitive and the cause was a negative reaction to gluten that caused serious problems in various systems of their body.

The doctor answering the question went on to state to the reader that there was no reliable test for gluten sensitivity, so whatever her nutritionist ordered was not medically approved.

There certainly IS a reliable test. And, not only is it substantiated by research as valid, it is also free – eliminate gluten from your diet for 30 days and see how you feel. If you notice an improvement, that is considered to be a valid test.

There is an anti-gliadin antibody test that measures the body’s immune system response to the protein gluten. If the body doesn’t consider the protein to be a problem then it wouldn’t make something called ‘antibodies’ against it. This test measures this reaction and can be found positive in those with gluten sensitivity as well as celiac disease.

A test offered by Cyrex Labs is considered 10 times more comprehensive. It analyzes a potential immune reaction to many different parts of the gluten protein, not just gliadin. It is thought that this will increase accuracy of diagnosis dramatically. 

Further, genetic testing exists for gluten sensitivity. These are not the same genes as for celiac disease, but they can be measured .

Lastly, telling someone that a test isn’t medically approved is insinuating that it’s invalid or worthless. Our medical profession really shouldn’t be casting stones considering it only diagnoses 5% of the celiacs suffering. If ‘medically approved’ tests were effective, wouldn’t we have a better percentage to show for it? 

Should 15% of the United States population (at least!) simply continue to suffer and not identify what’s really causing their health problems until the medical majority ‘deem’ that a test is now approved?  I think not.

The doctor also told the reader that if her symptoms resolved after one month and the dietary change didn’t stop working several months later, then she is likely gluten sensitive.

You may wonder what my disagreement is here, considering I myself state above that eliminating gluten for a month is a valid test. It’s not that part that I have a problem with, it’s the section where she states that the dietary change ‘doesn’t stop working’ several months later. Let me explain:

I’ve been working with patients suffering from celiac disease and gluten sensitivity for almost two decades, and I can tell you that often the initial benefits that patients notice when removing gluten don’t always stay corrected. Why? It’s not because gluten isn’t the problem, it’s because, like peeling layers of an onion, there is another layer of health issues that needs to be addressed.

This is why I specialize in treating the secondary effects of gluten. If removing gluten from the diet was the only thing a gluten intolerant individual had to do, optimizing the health of these individuals would be easy. Unfortunately removing gluten is often just the beginning. 

Now don’t get discouraged, the secondary effects are not difficult to treat, nor do they need to take a lot of time. They simply need to be tested for and treated appropriately in order to truly regain optimal health.  So it’s not abnormal for this to occur, but if everyone who had a symptom return then decided that gluten wasn’t really their problem, we would have a lot of needlessly ill individuals doing more harm to themselves.

And finally, the doctor informed her reader that people often feel better on a gluten free diet because they are eating less food overall due to fewer choices.

Really? Well I don’t find that to be the case at all. My practice is in Silicon Valley, California, a major metropolitan area. The reader was from Oakland, also a large city nearby, and the doctor answering her question was also local to this same area. So while I could have cut her some slack if she was writing from Arkansas or some small town where gluten-free products were not widely available, making such a statement from a large city really made no sense to me. Not only are there abundant sources of food that are naturally gluten-free including every fruit, vegetable, nut, seed, bean, legume and animal product (eggs, fish, meat), there are also an abundance of typically gluten containing foods that are widely available gluten-free.

I hope you find this to be helpful. I am committed to educate and increase awareness of gluten intolerance to this planet. Every inroad we make in this area saves lives. Please let me know any questions that you have.

Need Help? We're Here for You! 

If you felt as if I was describing you above, you are not alone. As I mentioned earlier, adrenal fatigue/exhaustion is almost epidemic. If you would like assistance and don’t have a clinician whom you feel can assist you, consider contacting us for a FREE Health Analysis. We are a Destination Clinic and treat patients from across the country and internationally. We would be delighted to help you as we have been doing so for over two decades.

Visit us at www.RootCauseMedicalClinic.com. If you have questions or need any help, I’m here for you! Call 408-733-0400.

I look forward to hearing from you.

To your good health,

Dr Vikki Petersen, DC, CCN, CFMP


IFM Certified Practitioner

Founder of Root Cause Medical Clinic
Co-author of “The Gluten Effect”

Author of the eBook: “Gluten Intolerance – What You Don’t Know May Be Killing You!”

Why Do So Many Celiacs Take Drugs?

I was reading a position statement from a national celiac organization regarding making it law that all gluten is removed from medications. While I completely concur, the issue I’d like to discuss involves a statistic that this organization gathered after surveying its members.

They found that according to survey, those with celiac disease take an average of eight oral medications per day. Eight! 

Potential gluten contamination aside, when someone takes that amount of medication it is known that an adverse drug reactions is definitely occurring – the likelihood is considered 100%.

What I would like to discuss is why celiacs would be, on average, consuming so many medications. They should be following a gluten-free diet that would, theoretically, improve their health dramatically. But apparently that is not the case.

Here are my thoughts as to what might be contributing to this problem:

       1. Some celiacs are a bit ‘sloppy’ on their gluten-free diets because they haven’t been well educated or they simply don’t notice a difference in their health when they knowingly cheat. Whether you 'feel' it or not, consuming gluten when you are gluten intolerant is increasing your risk of dying from all causes, especially heart disease, cancer and autoimmune disease, our three leading causes of death.

       2. Due to our poor ability to diagnose celiac disease (95% remain undiagnosed in this country), even those who now have the diagnosis often waited about a decade to find out. During that time their health was so compromised that autoimmune and other diseases developed that are now being ‘managed’ by drugs. While those in this position may feel that drugs are their only option, I disagree. We have seen nice improvements in the diseases caused by gluten, even in those who have suffered for many decades. See #3 below for more information on how we treat this.

       3. Generally speaking the treatment for celiac disease and gluten sensitivity is a life-long gluten-free diet – period. Unfortunately, eating gluten-free alone is usually insufficient to restore health. What I like to call the ‘secondary effects’ of gluten must also be addressed, to truly restore optimal health. Such things as ‘hidden’ infections in the intestines, nutritional deficiencies, probiotic imbalance, enzyme insufficiency, the presence of cross-reactive foods, toxic overload and hormonal imbalance must all be evaluated and addressed if found to be lacking. Neglecting this type of follow-up, in my opinion, diminishes the chances of a full recovery and is currently one of our largest problems in treating the gluten intolerant population.

      4.  Those who do follow the diet, often happily replace all the gluten-containing foods they used to eat with a gluten-free option, but don’t take steps to really eat a healthy diet. The bad news is that a gluten-free diet doesn’t necessarily equate to a healthy one. Too often, in order to appease the feeling of deprivation, gluten intolerant individuals throw themselves into overeating the vast array of cookies, cakes, breads and other goodies offered by the gluten-free manufacturers. While we are all delighted that such an abundance of gluten-free food is available, it doesn’t make that cookie or cake any healthier for you. These ‘goodies’ should be relegated to special occasions and, instead, the bulk of the diet should be made up of healthy vegetables, fruits, beans, good fat and a small amount of healthy animal protein.

Please pass this post along to others whom you know suffer from gluten intolerance. It’s hard enough to get diagnosed. Once you do and you’re following a gluten-free diet, you deserve to be enjoying excellent health.

What are your thoughts on this? 

Do you take more medications than you’d like?

I would love to hear from you.

Need Help? We're Here for You! 

If you felt as if I was describing you above, you are not alone. As I mentioned earlier, adrenal fatigue/exhaustion is almost epidemic. If you would like assistance and don’t have a clinician whom you feel can assist you, consider contacting us for a FREE Health Analysis. We are a Destination Clinic and treat patients from across the country and internationally. We would be delighted to help you as we have been doing so for over two decades.

Visit us at www.RootCauseMedicalClinic.com. If you have questions or need any help, I’m here for you! Call 408-733-0400.

I look forward to hearing from you.

To your good health,

Dr Vikki Petersen, DC, CCN, CFMP


IFM Certified Practitioner

Founder of Root Cause Medical Clinic
Co-author of “The Gluten Effect”

Author of the eBook: “Gluten Intolerance – What You Don’t Know May Be Killing You!”