Tag Archives: ALV003

So, did I get into the Celiaction study?!

Sorry, guys. I didn’t mean to hold out on you, but you know how summer gets. You’re busy with your NEW projects, like relearning to play the guitar or jab-cross-hooking at the local kickboxing studio, all while trying to soak up as much sunlight as you can on those glorious long weekend days. The computer is the last place you want to be (especially if—cue the whining—you’re still trying to avoid screens in an effort to kill your sleep problems).

As I’ve mentioned, before officially enrolling in the Celiaction study I had to undergo an endoscopy (with multiple biopsies) to prove I still have intestinal damage and can therefore reasonably blame my ongoing symptoms on celiac disease, rather than a mystery ailment, hypochondria, or “somatization disorder.”

The endoscopy went down last week and was about as much fun as it always is to eat and drink nothing for twelve-plus hours, don an IV bag and a precariously fastened tent of a hospital gown, and get a camera stuck down your throat and into your intestines. (Getting paid for it, I admit, was pretty fun.)

no gluten hospital bracelet

My hospital ID and “allergy” bracelets. I also had a big “NO GLUTEN” sign on my bed in case someone gave me crackers while I was too drugged to resist.

For extra enjoyment, I woke up in the middle of the procedure. I was certain I was going to throw up and suffocate myself, but I stayed still, expressing my panic only through my now-wide-open eyes. I distinctly remember my doctor saying, after she noticed I was awake and before they put me under again, that I was being “such a good patient.” (That may be an anesthesia-induced hallucination, but I’m proud of it nonetheless.)

Celiaction study coordinator with my biopsy samples!

Shipping my intestines off for inspection

The study coordinator kindly consented to be photographed with the package of samples taken from the intestinal lining of yours truly, en route to the lab. I went home to sleep it off, and then—like all of you have been doing, I’m sure—I waited.

Are my guts damaged enough?, I wondered. Oh, please, let my guts be damaged enough.

Well, the verdict is in . . . and so am I! I’m not sure yet of the exact Marsh score, but the biopsies showed mild damage—an improvement over the “diffuse subtotal to total villous atrophy” I used to have, but not a full recovery. So, yay! I’m in the study! I’ll keep making my phone calls and soon I’ll start taking either ALV003 or a placebo.

No one will know which I receive—not me, not the researchers. Many other things are equally uncertain. Will I feel better? If I do, will it be due to the drug? The placebo effect? The kickboxing? Or just time, steadily continuing to do its work?

Because it’ll be so uncertain why I’m feeling however I’m feeling in a few weeks or months, the study coordinators have asked me to refrain from publicly sharing my health progress during the trial. Out of context, my symptoms or lack thereof won’t reveal anything about the medicine’s effect, but my reports still might unduly influence someone else in the study who happened across this blog. In the name of Science, I’m happy to oblige the request (and was flattered to receive it!).

So, this is the last you’ll hear from me for now on how I’m doing (middlingly). I’ll still likely write about the study, just not my symptoms. If you find yourself dying to know how I am, and you aren’t in the study yourself, I welcome any and all questions, however personal, by email. Otherwise—assuming my summertime laziness subsides—I’m sure we’ll find plenty of other stuff to talk about!

What are your summer projects? How was your endoscopy experience?

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Is a gluten-free diet good enough?

Last week, I had the pleasure of attending Columbia University’s Development of Therapies for Celiac Disease Symposium. Doctors and researchers from around the world gathered to present fascinating talks and Powerpoints full of text almost all too small to read.

Also attending were patients, like myself, and some folks doing fantastic work on behalf of the gluten-free community. Hearing their stories was my second favorite part of the conference. Glimpsing the most cutting edge of celiac science was my third.

First, of course, was the food. Everything served was gluten-free; and, it seemed, everything was served. Bread baskets overflowed, and entrees and sides kept even us vegetarians happy (saag paneer—yum). There was dessert after every meal, even breakfast—which was itself essentially dessert, consisting primarily of muffins, donuts, fruit, yogurt, and “coffee” cake.

In two days I ate more desserts than anyone should eat in a month. I can’t tell you how many exactly, because a) it would be embarrassing and b) I lost count, but brownies, crème brûlée, polenta cake, kheer (Indian rice pudding), and pound cake were not excluded. Some treats were from Pink Poppy, others from By the Way Bakery. So. Much. Sugar.

gluten-free muffins, donuts, and bagels at conference

The lighting doesn’t do them justice, but trust me: delicious unfrosted cupcakes muffins.

As if all that weren’t enough, we were also encouraged to take samples, and take them I did: The Simply Bars, Crunchmaster multi-grain crackers, NoGii paleo bars, Schar multigrain ciabatta rolls, and Le Veneziene chocolate hazelnut cookies. The cookies expire in a month, so we’ll have to eat them fast.

Okay, okay, I admit: the point of the conference was not the food. The point was to learn about gluten-related disorders. And I’m evading that point because the conference’s unofficial motto was “Good question! We can’t answer it.”

Much about celiac disease and gluten sensitivity remains uncertain, due to conflicting study results, lack of longitudinal and prospective data (meaning, collected over a period of time as events unfold, unhampered by subjects’ flawed memories), lack of appropriate controls, or the fact that serious research attention hasn’t been paid to this field until recently.

Celiac disease is not a simple disease. You know that, I know that, scientists know that, and (some) doctors know that. Unfortunately, that’s about all we know.

Still, because I did learn a lot about what we don’t know, this will be my first in a series of posts about the questions the conference raised, and the answers that may someday prove to be true—at least in part. I call it “Sprue/False.”

We start with a big one:

This question was at the symposium’s heart. If “go gluten-free” were all we needed, no one would be developing therapies (other than snake oil peddlers). “Go gluten-free and wait” is another option. Multiple presenters affirmed it can take years for adults to heal. But is that the best we can do?

Unsurprisingly, the drug developers say no. Glutenase (a.k.a. ALV003, and importantly distinct from “Glutenease”) researchers had a pool of about 200 gluten-free celiac patients keep a seven-day symptom diary. Over 90% had at least one day of symptoms, and 44% reported five to ten symptoms. Three quarters called their symptoms “moderate,” “severe,” or “very severe,” and 20% missed social events or called in to work.

Also potentially significant is the fact (stated in another presentation) that even on the gluten-free diet, adults’ villi may never rebound to “normal” length—meaning, possibly, we don’t regain the ability to absorb nutrients as well as we should. Yet another presenter suggested we may be wrong to assume that all is peachy—from a health perspective—for diagnosed kids.

We see an unmet medical need,” said Daniel Adelman, of Glutenase. “The gluten-free diet is all we’ve got, and it’s not enough.

But doctors aren’t so sure. Dr. Julio Bai’s comment that his patients did not make such complaints met with widespread head-nodding from clinicians. More than one expert scolded the drug developers for not surveying a control group. “For all we know,” their argument went, “everyone would report weekly gut symptoms if given the opportunity.”

I’m disappointed they didn’t include controls, but otherwise, I’m with the druggists. I’ve been scrupulously gluten-free for well over a year and still don’t feel well. And faulty memory, schmaulty memory, I know it wasn’t like this before. There has to be something more I can do. The question is, what?

Patients can help answer that. Both Larazotide and Glutenase—drugs being developed as adjuncts, not replacements, to the GFD—are in clinical trials. Neither trial is currently requiring participants to deviate from their usual diet, and both have been through extensive safety testing.

I’m investigating Glutenase’s CeliAction Study, myself. Celiac changed my life and so far the GFD hasn’t changed it back. I’m ready to try something new. Worst case scenario, I get a placebo or the drug doesn’t work. Best case? My life returns to really, truly good enough.
gluten-free Fridays Vegetarian Mamma
Over the next few weeks I’ll explore more unanswerable questions about gluten-related disorders, with less preamble about brownies. In the meantime, tell me: In your experience, is the gluten-free diet enough? Would you ever participate in a clinical trial? Have you already?

Post #2 on the conference is up: check out “More on Drugs” and share your thoughts!

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