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Enterolab Testing & Validity?
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Hey guys! I'm still very new to this whole celiac disease thing, but I've just received my Enterolab box to gene test & test for gluten sensitivity...plus other things. I ordered this out of desperation for some sort of answers after all my blood work has repeatedly come back negative. As with so many people on here, I just want some answers. I'm currently gluten free, so I refuse to do a gluten challenge just for a biopsy.

So here's my question. My local Celiac support group isn't keen on Enterolab and said his testing methods were antiquated. From what I've read about Enterolab, it seems his testing methods are progressive and he seems to be able to find far more info about gluten intolerance than any other lab out there. What are your thoughts about my Celiac group not supporting Enterolab's testing?

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If you look in the biomedical literature, there is virtually nothing about stool antibody diagnostic testing. Enterolab has made the decision to only patent their tests, rather than doing proper controlled studies and publishing in the peer-reviewed scientific literature. This means that anyone with good scientific training (like me) will regard Enterolab with deep suspicion.

It is entirely possible that Eneterolab is onto something useful, but without controlled, peer-reviewed studies that address the reliability of the stool testing, the tests are scientifically meaningless. The genetic testing is known to have a very high false positive rate. 30% of the population is DQ2 or DQ8, while only an estimated 1-2% is celiac. Similarly, anti-gliadin IgA in both blood and stool are known to have very high false positive rates. The anti-tTA is entirely unstudied, so no conclusions can be made about the presence of antibodies. Notice that there is absolutely nothing on Enterolab's site about the false positive rate of their antibody tests.

IMO $350 is a ridiculous amount of money to pay for tests that cannot currently be considered diagnostic.

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Hey guys! I'm still very new to this whole celiac disease thing, but I've just received my Enterolab box to gene test & test for gluten sensitivity...plus other things. I ordered this out of desperation for some sort of answers after all my blood work has repeatedly come back negative. As with so many people on here, I just want some answers. I'm currently gluten free, so I refuse to do a gluten challenge just for a biopsy.

So here's my question. My local Celiac support group isn't keen on Enterolab and said his testing methods were antiquated. From what I've read about Enterolab, it seems his testing methods are progressive and he seems to be able to find far more info about gluten intolerance than any other lab out there. What are your thoughts about my Celiac group not supporting Enterolab's testing?

Many people here rave about Enterolabs. Sometime Enterolabs may be a piece of the puzzle. I don't share their enthusiasm, due to the fact that I have never seen any independent research to the validity/accuracy of their testing. Nor has Dr. Kenneth Fine published his research, after almost a decade of promising.

The summary results that I have seen, from others, often indicate that "a sensitivity or genes were found and everyone in the family should be tested" ...um, at about $300.00+ a pop. :blink: That bothers me, and that's why Enterolabs was not my road of choice. As you are aware, they state that they can test for sensitivities, not for Celiac Disease.

There is a great deal of discussion on Dr. Fine and Enterolabs in the archives here. Some, very emotions. Educate yourself and make the best choice based on what you learn. :)

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Yikes! I wish I had asked this question before I bought the test. Oh well, might as well do the test and cross it off the list. I think there are so many of us that feel so frustrated with being sick that we will try anything for an answer. My real answer came when I went gluten free and my dibilitating low blood sugar (<50 / 10x per day) was totally cured. My endo doctor said I would be diabetic within a matter of years, so I had to do something drastic. I knew that my GI symptoms and hypoglycemia were connected. Every doctor I've seen so far said there was no way these two issues were connected...bozo doctors! However, I do have 2 children and one is following in my footsteps. I'm keeping him on gluten so he can have the proper tests conducted at the hospital.

Thanks for the info. This forum has been an invaluable resource!

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Check out Dr. Fines CV at www.finerhealth.com/About/CV. He has published extensively in the field of gastroenterology. I read some time ago that he is preparing to publish on his more recent research but have not seen it yet.

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I decided to have the test for the DQ markers at Enterolab instead of having the biopsy. It cost about $200 four years ago and I have not regretted spending the money. I have read that Dr. Fine sends out the samples for DNA markers to a reference lab (I think it's the US National Blood Bank lab but you can check it out on the website). I would suspect that the problems your group has is has more to do with intrepreting the test results than with their accuracy. I have a background in molecular genetics and biochemistry and it took me a while and lots of reading to understand what the test meant.

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Check out Dr. Fines CV at www.finerhealth.com/About/CV. He has published extensively in the field of gastroenterology. I read some time ago that he is preparing to publish on his more recent research but have not seen it yet.

I've looked at that CV. It's on the Enterolabs website as well. Don't you find the total and complete absence of any attempt to validate his position on fecal antibodies and celiac disease worrisome?

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I've looked at that CV. It's on the Enterolabs website as well. Don't you find the total and complete absence of any attempt to validate his position on fecal antibodies and celiac disease worrisome?

No, mainly because I don't think intestinal biopsies are the best standard to judge the presence or absence of a gluten problem. Many testing methods live or die based on whether they can accurately predict measurable microvilli damage but this is a pointless standard because that damage is nothing more than another symptom of a larger problem.

Fecal antibody tests for IgA issues is not a novel medicine technique, the mucous membranes contain the majority of the IgA in your body and these are built to survive the digestive system.

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Ordering the test from Enterolab was probably the best thing I've ever done in my life. I was sick for months and months, worried sick because I had no health insurance. I read a lot online and celiac/gluten intolerance seemed to match my symptoms well. Still, I was skeptical that I had a problem with gluten and put off going gluten free for awhile. I finally got intensely ill and made the leap to go gluten free. I didn't feel a lot better at first and cheated a few times.

Then, when I got the test back from Enterolab, I saw that I was, in fact, created antibodies to gluten and to my own tissue. That did it for me. I've never cheated since the day I got those results back. I stuck to the diet like glue (no pun intended :)) and sure enough, within a couple months, I started feeling immensely better. I am LOADS better than I was this time last year, and were it not for the testing I did with Enterolab, I'm not sure I would have gone through with the 100% gluten free diet.

I have a lot of gratitude for what Enterolab does. It may not be accepted in the mainstream, and there will be skeptics, I completely understand that, but for me, personally, they were such a blessing.

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I also am very happy that I had Enterolab testing done. I didn't have it done until 5 years after diagnosis. It solved the mystery of why my DD was told she would never be celiac despite her previously positive diagnosis based on positive blood work and biopsy. It turns out I carry two copies of a gene that is not recognized as a celiac associated gene (at least at the time), by the US doctors. Their instance that only DQ2 and DQ8 are celiac associated genes, (the ones DD's doctors tested) resulted in her going into denial about her diagnosis. Unfortunately those wonderful doctors convinced her to go back to gluten and to think all her issues are now 'stress' related.

Enterolab also pinpointed my intolerance to soy. Eliminating that has allowed me to much more fully heal.

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I have a lot of gratitude for what Enterolab does. It may not be accepted in the mainstream, and there will be skeptics, I completely understand that, but for me, personally, they were such a blessing.

I second that.

There is much that is still to be learned about celiac. It is only recently that we have started seeing doctors accepting the relationship between mental illness and celiac, for one example. That adults can develop celiac and that is not just a childhood illness is another. The children don't outgrow celiac is another. I am thankful for Dr. Fine and his research, the patients who have the tests done, get the results and recover are, IMHO validating also.

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I am thankful for Dr. Fine and his research, the patients who have the tests done, get the results and recover are, IMHO validating also.

People who have positive test results and recover do not validate a clinical test. Making that assumption is what statisticians call a Type I error.

Can you please provide a link to Dr. Fine's research on fecal antibodies for which you are grateful? I have searched PubMed pretty carefully and I can't find anything.

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Just because you can't see God, do you believe, he's not there? Just because they don't have proof, you do believe, their tests are not valid?

I personally heard a lot of good stuff about them. I don't have health insurance either. And when I get my new job in September, I will get some tests done over them, cause I will still not have health insurance then.

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i'm healing because of the decision to use enterolab. it got the ball rolling so to speak. if you get the negative blood work you get discouraged again especially when you *know* gluten is the problem. not everyone gets the positive biopsy via endoscopy either. in one book/research site it will say 1 test is not conclusive. in another, endoscopy is golden. yet another you are told to combine them along with dietary response and you get your diagnosis.

enterolab is out there to help. i had a great experience with them. they answered questions for me without weeks of waiting and leaving messages. celiac is very misunderstood by many doctors out there. mine included ... just didn't know much about it. as with any illness, you have to be proactive and work with the doctors to find out what's going on ... unless you are comfortable putting your health into their hands.

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People who have positive test results and recover do not validate a clinical test. Making that assumption is what statisticians call a Type I error.

Can you please provide a link to Dr. Fine's research on fecal antibodies for which you are grateful? I have searched PubMed pretty carefully and I can't find anything.

Skylark, You are certainly entititled to your opinion. Those of us who have had the tests and acted on those findings are entitleded to ours. Each are opinions.

I did not use Enterolab for my celiac diagnosis I took the tests 5 years after diagnosis because my DD had her biopsy and blood positive celiac diagnosis recinded because of a gene test. She now attributes her symptoms to the stress of first school and now her job. Because of her test results I wanted to find out what genes we did carry. I also was still having some occasional issues and his tests pinpointed a reaction to soy and casien. After eliminating both I then progressed to as complete of a recovery as I will have.

I still have some neuro damage but doctors relied on the test forms that you consider to be the only valid ones, blood tests and biopsy. They wouldn't do a biopsy since my blood work was negative and a later challenge demanded by my GI after I had been gluten-free as ordered my my allergist, a well respected physician, almost killed me so I finally got my doctor derived diagnosis. I am seronegative and I suffered for years while my brain and body continued to be under attack.

Dr Fine, as you seem aware, applied for a patent for the testing in 2001 and recieved it in 2003. There is much info in that patent application, you can do a search for it if you like I don't have time this morning.

Celiac research is continueing and they are 'discovering' more and more everyday. In some countries they use a rectal or oral challenge where gluten in used by injection or suppository and the tissue is biopsied hours later. In those countries that form of testing is considered valid and celiacs get diagnosed an average of 2 weeks after first symptoms are seen. In the US those tests are not used because they are considered too sensitive and diagnose before the villi are gone. In some countries MRI's are used to diagnose neuro impact celiac by the findings of UBO's on the scan. Here those same UBO's seen on my scans had my neuro shrug his shoulders and say 'lot's of people have those, they mean nothing, here's a script for prozac.

There is still much to learn about celiac. I, for one, can't wait until we start to diagnose people sooner rather than later. It sure would have been nice to not have lost years of my life. It would have made a great difference in my childrens lives also.

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I think it is important to keep medical tests in perspective. As much as some may look at medicine as a science, much is guesswork. For example, many studies show a correlation between celiac and other diseases, but no one has yet proved the connection. Another example is the current dispute over celiac being primarily a gut disease or a neurological disease with gastrointestinal issues only in some patients. Not surprisingly, there are no firm definitions of gluten intolerance, and no generally accepted tests.

Against this backdrop we should keep the goal of health firmly in focus. If a test indicates a gluten intolerance, and dietary change brings improved health, the test was beneficial.

Maybe those who evidently believe that only "proven" tests be used can tell us what someone should do when serologic and biopsy are negative, but symptoms go away when gluten is removed from the diet? Maybe they could also explain the validity of the "normal" range for serologic tests, why different labs have different ranges, and why ranges from the same lab change over time. And the relationship between the range and health in any particular patient.

Our scientific knowledge has limits. We have to recognize those limits and still do what we can to stay healthy.

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People who have positive test results and recover do not validate a clinical test. Making that assumption is what statisticians call a Type I error.

Actually that has nothing to do with a type one error...

Wiki

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Look, everyone is attacking me and I suppose that's normal for the kid who says the emperor has no clothes. It just breaks my heart to see all these people wasting $349 on unvalidated tests. That's a lot of money for a piece of paper from a lab that doesn't even tell you the false positive and false negative rates of their tests. (i.e. how many non-celiacs have fecal anti-gliadin IgA, and how many biopsy-proven celiacs test negative?)

Medicine may be part art, part science, but diagnostic testing is most certainly science. Assay validation is fairly straightforward and before an assay can be included in the "art" of medicine, those studies need to be done.

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1). Back up your statements.

2). Assay validation and publishing are not the same things. I suspect Enterolab would tell you that they have validated their assay. It's not common for a company to publish, since they don't need to. They haven't received government money and won't be asking for government money in the future.

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Hi Skylark, I appreciate your input. As well as everyone elses. You are very educated in science. However, I think both sides are relevant and there are places for both sides of the fence. I think most of us just wish science factored in more variables. It's possible. Science tries to fit every human into the same box when conducting a test and then to validate that test, but we know there are better parameters. It's just expensive. So, no one does it.

There is a norm in the science world to proof tests, and for the most part it's effective. But, then there are doctors. And labs. They can screw up, contaminate blood samples, lab errors, etc... Then, what are the patients left to do. We know we feel awful and we are pretty sure we know why, but we'd like proof.

Then there are insurance companies. I've been uninsured trying to find an answer and I've been insured trying to find an answer. I can tell you that in my experience, being insured is far more costly than not. Disclaimer, in the event of a major catastrophic illness or accident, the insurance will probably come in handy. But, for everyday use it's expensive and a total rape on the average American. Between monthly premiums, deductibles, paying 20% my portion on ALL labs, doctos fees, readings, etc... Well, let us just say that I'd rather use Enterolab to find a gluten sensitivity rather than paying thousands a year in hopes some doctor out there will take the time to be educated enough to treat me. $400 is a far easier gamble even if the test isn't validated in the medical world. In some countries it is, just not here. So, who's right?

In the meantime, we eat gluten-free :D

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Look, everyone is attacking me and I suppose that's normal for the kid who says the emperor has no clothes. It just breaks my heart to see all these people wasting $349 on unvalidated tests. That's a lot of money for a piece of paper from a lab that doesn't even tell you the false positive and false negative rates of their tests. (i.e. how many non-celiacs have fecal anti-gliadin IgA, and how many biopsy-proven celiacs test negative?)

Medicine may be part art, part science, but diagnostic testing is most certainly science. Assay validation is fairly straightforward and before an assay can be included in the "art" of medicine, those studies need to be done.

Enterolab doesnt dx celiac, only gluten intolerance.....

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How do I back up my statements? I couldn't figure out how to link to PubMed to show empty search results on a search with Fine as author and "antibodies". Typing "fecal antibodies celiac" into PubMed produces only 34 results in the whole database, and there are really no studies that support Fine's assertions.

The genetic testing interpretation is interesting at Enterolab. Basically, if you order a genetic test, you have better than 81% chance of Enterolab telling you that you are predisposed to gluten sensitivity.

From their FAQ. "How common are the gluten sensitivity and celiac genes?"

DQ2 is present in 31% of the general American population. DQ8 (without DQ2) is present in another 12%. Thus, the main celiac genes are present in 43% of Americans. Include DQ1 (without DQ2 or DQ8), which is present in another 38%, yields the fact that at least 81% of America is genetically predisposed to gluten sensitivity. Of the remaining 19%, most have DQ7,7 (an allele almost identical in structure to DQ2,2, the most celiac-predisposing of genetic combinations) which in our laboratory experience is associated with strikingly high antigliadin antibody titers in many such people. Thus, it is really only those with DQ4,4 that have never been shown to have a genetic predisposition to gluten sensitivity, and this gene combination is very rare in America..."

For the stressed-out person wanting something to confirm their dietary gluten sensitivity, it doesn't get any better than that!

The Enterolab FAQ page says in reference to stool antibodies "Extensive research has revealed that this hypothesis is true, and has resulted in the development of new methods for detection of gluten sensitivity, celiac sprue, and other food sensitivities." but the statement is not referenced at all.

Here is a recent study on serum and anti-gliadin IgA. The authors did fecal as well as serum anti-gliadin antibodies and for starters they found a poor correlation between the two.

"CONCLUSIONS: In both studied populations of adults and children, AGA disappeared in more than 50% of the cases. The appearance of AGA has to be interpreted as a non-specific immunomodulation phenomenon, confirming the low specificity of AGA as a serologic marker for celiac disease."

http://www.ncbi.nlm.nih.gov/pubmed/16607144

This fecal antibody study on anti-gliadin IgA and anti-TG2 IgA came to the conclusion "Neither stool test was suitable for screening for coeliac disease in children with symptoms."

http://www.ncbi.nlm.nih.gov/pubmed/16377644

The really good assay for genetic gluten sensitivity and/or celiac is for either IgG or IgA against anti-deamidated gliadin, which as far as I can tell Enterolab doesn't use.

http://www.ncbi.nlm.nih.gov/pubmed/20022983

http://www.ncbi.nlm.nih.gov/pubmed/20456302

http://www.ncbi.nlm.nih.gov/pubmed/20171961

Even deamidated gliadin IgA can disappear with time, making it still an iffy marker in the absence of anti-TG2 or anti-endomysial antibodies.

http://www.ncbi.nlm.nih.gov/pubmed/20357057

Anti-TG2 is known to be problematic and prone to cross-reactivity.

http://www.ncbi.nlm.nih.gov/pubmed/15936306

http://www.ncbi.nlm.nih.gov/pubmed/16987503

This study shows that fecal anti-TG2 antibodies are a marker for inflammatory bowel disease and that anti-endomysial antibodies are a better marker for celiac.

http://www.ncbi.nlm.nih.gov/pubmed/15552265

And studies showing that fecal anti-endomysial antibodies would be the correct marker for celiac.

http://www.ncbi.nlm.nih.gov/pubmed/8210980

http://www.ncbi.nlm.nih.gov/pubmed/11808976

So, basically Enterolab is looking at anti-gliadin IgA, which might be produced by normal immune systems, and anti-TG2 IgA, which is produced in other disease states.

The markers specific for gluten sensitivity and celiac disease would be probably be fecal anti-deamidated gliadin IgA/IgG and fecal anti-endomysial IgA.

This doesn't even begin to address the issues of assay accuracy and reliability, false positives, false negatives, and other information about the tests that is not provided by Enterolab.

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The issue I have with the majority of those studies, and the reason most people turn to Enterolab, is that the authors relied on a positive biopsy, or positive serum markers to determine who has Celiac Disease. Many people here will tell you that they tested negative, but removing gluten from their diets has made a tremendous change in their health.

Where are the studies correlating enteric antibodies with feeling ill, subsequently relieved by adopting a gluten-free diet? Why didn't they test people with digestive issues, look at antibody panels, have them all stop eating gluten and correlate reported wellness with presence or absence of gliadin related antibodies?

You are starting from the assumption that existing diagnostic tests are sufficient. I am starting from the assumption that, just because we don't know how to test for it, doesn't mean it doesn't exist.

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The issue I have with the majority of those studies, and the reason most people turn to Enterolab, is that the authors relied on a positive biopsy, or positive serum markers to determine who has Celiac Disease. Many people here will tell you that they tested negative, but removing gluten from their diets has made a tremendous change in their health.

Where are the studies correlating enteric antibodies with feeling ill, subsequently relieved by adopting a gluten-free diet? Why didn't they test people with digestive issues, look at antibody panels, have them all stop eating gluten and correlate reported wellness with presence or absence of gliadin related antibodies?

You are starting from the assumption that existing diagnostic tests are sufficient. I am starting from the assumption that, just because we don't know how to test for it, doesn't mean it doesn't exist.

I'm not saying existing diagnostic tests are sufficient at all. It's particularly devastating that getting any hope of a positive result involves destroying ones body with gluten. You asked for references and I did my best from what's out there.

You ask the exact question I'm asking. Where is the study correlating fecal AGA or anti-TG2 antibodies with feeling better off gluten? You would also need a false positive rate by testing a control group of healthy people. Calling out Enterolab for charging people a bunch of money without doing this (or at least providing a reference to someone who has) apparently makes me a bad guy. :(

I know! Send me only $100 and I'll send you a piece of paper showing that your blood is red. I understand red blood is strongly correlated with gluten sensitivity and you should try a gluten-free diet and see if you feel better. ;) (Going to an extreme in an attempt at humor!)

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I'm pretty much at the point where, you have to stop eating gluten and not feel different for me to believe you don't have an issue with gluten, but some people still need some diagnostic test in their hands. If you consider that the majority of people that come to this site have some gastrointestinal issue, for those people that need a test, Enterolab is not a bad choice. I don't believe the current lab tests of antibodies and biopsy are sufficient to diagnose issues with gluten (call it celiac disease, or gluten sensitivity) so if you are unwilling to try the diet without a diagnostic test, then the $400 or whatever dollars is money well spent. You'll try the diet and continue it if it works, and not continue it if it doesn't.

I personally don't think any laboratory testing is worth doing for this issue. If you change your diet and you feel better, then why pay for a lab test? There is nothing unhealthy about gluten-free eating, and any related diseases that might come up would be treated based on symptoms and other lab tests anyway. (This doesn't hold for people who are already experiencing related health issues.)

As to the studies correlating fecal testing with feeling better, where are the studies correlating improvement on gluten-free diet in subjects who test negative for celiac disease using conventional testing? I think that system is just as flawed. And those tests cost a bunch of money too, it's just easier not to see it because insurance "pays" for it. If you work in a small company, you may find that your insurance costs go up relative to the amount the employees use. You do a bunch of diagnostic tests, your costs are divided up among the other employees and the company. The labs still get the same amount of money, and it's not coming out of the insurance companies' pocket....

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    • To answer some of your questions.... Non celiac gluten sensitivity does not cause any damage to the small intestine so that is not the source of the "little holes or bumps".  You need to get her records including the report of the endoscopy to see exactly what it says as well as the pathology report of the biopsies. You should always get medical records anyway & keep a copy for yourself. How many biopsies did he take? There should be a minimum of 4, ideally 6. The small intestine is very vast even in a small child. An adults is the size of a tennis court! That's a whole lot of territory so biopsies can miss damage especially when enough of them are not taken! She has 2 positives on the serum panel. This crap about "weak" positives should be thrown out of the nomenclature! A positive is a positive, weak or not! Her DgP IGG is way over the range and extremely telling. As far as my knowledge goes, there is nothing else that causes a positive DgP IGG other than celiac disease. False positives are really rare and to have 2 false positives would be astronomically rare! You are right & smart that she really does need an official diagnosis! IMHO, keep her on gluten for right now. Get a second opinion pronto & I believe you'll be able to get her a dx based on the 4 out of 5 rule if nothing else. I wouldn't think it's going to take more than a month to get to see another doc for a second opinion. Then you can take her off gluten. Kids heal up really fast, way faster than us old geezers! I'm sure as others  wake up & get on their computers they will be along to voice their knowledge. I am in the eastern time zone & rise before the birds so I was on here early. Hang in there mom! You're doing the right thing!
    • Now that my initial rage has calmed a tad.... your daughter has to fulfill 4 out of 5 of the diagnostic criteria. Second opinion can do a gene test. If positive, then she will have4 out of 5 of the dx criteria to dx without a positive biopsy. See: http://www.gastro.org/news_items/a-biopsy-should-not-be-required-to-make-the-diagnosis which says in part: The presence of signs and symptoms compatible with celiac disease. Positive serology screening (high serum levels of anti-TTG and/or EMA). Presence of the predisposing genes HLA-DQ2 and/or –DQ8. Histological evidence of auto-insult of jejunal mucosa typical of celiac disease. Resolution of the symptoms and normalization of serology test following the implementation of a gluten-free diet.   Also see: http://www.tenderfoodie.com/blog/2014/5/1/dr-fasano-on-new-gut-autoimmune-research-autism-clearing-up.html She can get a dx after her symptoms resolve on a gluten-free diet!
    • OMG!!!! The doc wants her to get sicker & sicker & do further damage so he can diagnose her? Don't do me any favors doc!!! I'm so spitting med right now I can't even speak! Find a new doc, take the records & get a second opinion. Maybe the next doc will have a freaking brain & dx your daughter. She should be dx'd! This is absurd in the extreme. The very least that should happen is the doc give her a dx now & then in a year or 2 have her do a gluten challenge & do a biopsy all over again but seriously, that would be just as cruel as what he's doing now. He's an ASS!
    • Celiac disease may lead to a host of other inflammatory, gluten-related ... Fortunately, Diet Doc offers gluten-free diet plans which are customized to ... View the full article
    • Cyclinglady is absolutely correct, after hours of internet research the only gluten-free food available at JNB is a fast food chain called 'Nandos'. I was hoping for a bit more variety, but I'll take what I get.   
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