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Fda Comment Period Open For 20 Ppm Standard For Gluten Free
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28 posts in this topic

The problem may be ethical rather than technical: it may not be ethical to give gluten to people who are already known to be extremely sensitive.

Good point, as well. :-) I wonder if a more ethical study concept would be to take celiacs who are NOT healing, like those diagnosed with refractory celiac disease, and start the trial working the other way around: trying to heal them. Have some on 20mg a day, some on 10 mg a day, and some on a 'super' gluten free diet of even less than that. See if the condition improves.

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Good point, as well. :-) I wonder if a more ethical study concept would be to take celiacs who are NOT healing, like those diagnosed with refractory celiac disease, and start the trial working the other way around: trying to heal them. Have some on 20mg a day, some on 10 mg a day, and some on a 'super' gluten free diet of even less than that. See if the condition improves.

I think that it would be a great study to take people who haven't healed and put them on a diet like ours. It has worked for several of "us", but not within the confines of a study.

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My other concern with the safe threshold study is that it lasted for 90 days. Is that long enough?

http://www.ajcn.org/...t/85/1/160.long

The authors of this paper pointed out that there were ethical challenges in continuing a clinical trial in which intestinal damage was clearly being caused by the gluten administered to the patients.

Now that I think of it, I wonder if such a clinical trial would be approved in the US? It seems that most of these studies are done overseas.

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