Fda Comment Period Open For 20 Ppm Standard For Gluten Free

[T.H.]

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.

[dilettantesteph]

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.

[U Gluten Free]

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

Open Original Shared Link

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.