Tag Archives: clinical trials

Symptomatic celiac disease driving you crazy? Then try CeliAction with me!

“The definition of insanity is doing the same thing over and over and expecting different results.” A whole bunch of dubiously wise people have told me that. The quote’s attributed to every famous smart person ever, usually Albert Einstein, and it has a certain ring of truth. So I hope you won’t blame me for wondering . . .

Am I insane?

If Albert Einstein said it, it must be true.

If this guy said it, it must be true. (Psst: he didn’t.)

I’ve been dutifully eating gluten-free for nearly a year and a half. But despite saying no to wheat, rye, barley, and even oats over and over again, I’ve seen so little improvement in my health that celiac disease is starting to seem like a sick joke. I can’t help but wonder: Are all those people who claim to recover just punking me? Are you? Is it crazy to continue a rigid, socially hobbling diet without any signs that it’s working?

Luckily, when these questions were threatening to make me really insane, I found a great Psychology Today article dismantling this “definition of insanity.” Ryan Howes argues that many use the cliche as an excuse to avoid the long-term, difficult, and sometimes thankless work of self-improvement. They confuse perseverance—a “strong, valuable quality”—with perseveration, a particular psychological issue. Howes writes:

Repeating the same constructive behavior over and over, hoping (one day) for a positive result is difficult but virtuous. . . .

Perseveration feels compulsive, hopeless, helpless, automatic and unsatisfying. There is a desire to stop, but stopping doesn’t feel like an option. Perseverance feels like striving toward a noble goal, and whether or not it’s reached . . . there is virtue in the effort.

Now, I can’t say that avoiding gluten never feels compulsive, hopeless, helpless, automatic, or unsatisfying. But usually, I feel I’m doing something constructive in hopes of (eventual) better health. The day-to-day results may be nil, but I won’t be giving up my diet anytime soon.

On the other hand, just as it’s not crazy to keep striving in the same way for a noble goal like health, it’s also not crazy to try something new. If you aren’t seeing as much progress as you’d like, it’s a good, sane idea to take extra steps that might help you reach your goal and keep you from going nuts along the way.

That’s why I’m excited to report that I have enrolled in the CeliAction Study!

The CeliAction Study is testing ALV003, a medication intended to break gluten into pieces too small for the immune system to recognize. Even careful people like you and I probably get trace contamination; this drug may keep our immune systems from punishing us for it. It’s worked in a test tube, and only science will tell whether it works in humans.

Now, I don’t believe in medicating problems that have effective, simple, non-pharmaceutical solutions. But I do believe in medicating everything else. If the gluten-free diet were good enough for everybody, I’d be shaking my head at those money-grubbing drug companies with the judgiest of ’em. But for many, it isn’t. I believe that developing new therapies for celiac disease is a necessary cause, and I look forward to supporting it. If you’re interested, I invite you to join me!

You can enroll if you have celiac disease, have been gluten-free for a year, still have symptoms, and are close enough to one of the many study locations (see contact info for the Columbia location here). You’ll continue on your gluten-free diet and do a few other things over the course of 28 weeks:

  • Get bloodwork and endoscopies done toward the beginning and end (fo’ free)
  • Call a special system every night to report on your symptoms (then drift off to sweet dreams about satisfying bowel movements)
  • Stir the powdered medication into a beverage and drink it at each meal
  • Not get pregnant
Only 30% of participants get the placebo, so odds are OK you'll be stirring the real thing into your water glass. (Photo © Dennis Skley | Flickr)

Only 30% of participants get the placebo, so odds are OK you’ll be drinking the real thing. (Photo © Dennis Skley | Flickr)

Like another infamous study, it’s placebo controlled (and double blind), so you won’t necessarily get the drug, and either way you won’t know. You also have to show ongoing intestinal damage in the first endoscopy to be given the drug or placebo. But IF you get the drug, and IF it works, THEN your quality of life might improve.

If those ifs don’t work out, at least you get to be one small cog rolling forward the machine that is scientific progress. Plus you get paid (cha-ching!), and if you’re loving the drug at the end, you get to keep taking it for a while. (Unclear whether that holds if you’re on the placebo. But hey, if the placebo works I’ll take it.)

It’s quite possible I’ll hate the phone calls by the end of the study, and maybe I still won’t feel better. Maybe I’ll feel crazy for having gotten myself into this.

But mostly, I hope, I’ll be happy that I’m persevering toward my noble goal of better health. And if you’re still striving for it yourself, I’ll appreciate the company. Us crazy people gotta stick together.

Does managing a special diet ever make you feel a bit insane? What new things have you tried in pursuit of health? Are you considering the CeliAction study?

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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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