Reviewer's report
Title:Search for atoxic cereals: a phase II, single blind, cross-over study on
safety of a single dose of Triticum monococcum in patients with celiac disease
Version: 1Date:23 February 2013
Reviewer: Stefano S Guandalini
Reviewer's report:
This study aims at assessing the safety of an ancient grain, Triticum
monococcum, in celiac patients.
This author's main criticism is centered on the choice of the intestinal
permeability (IP) test as a valid measure of the effect of acute gluten toxicity in
celiac patients.
In fact, contrary to what is stated ("a method to assess changes of small
intestinal permeability that is known to increase in CD patients exposed to
gluten[11]", IP is not an accepted parameter to evaluate the toxicity of gluten in
celiacs. In fact, reference 11 simply reports, among other elements, the fact that
2 previous studies only (conducted in 1982 and 1991) showed that gluten
induced an acute change in IP. Of note, the 1991 study (Ref.: Greco L, D'Adamo
G, Truscelli A, Parrilli G, Mayer M, Budillon G. Intestinal
permeability after single dose gluten challenge in coeliac disease. Arch Dis
Child. 1991 Jul;66(7):870-2.) uses a dose of gluten (50g) that is 20 times higher
than that employed in the present study!
In other words, the design of the study was doomed to fail to show any benefit of
the ancient grain compared to 2.5g of gluten.
For the rest, the paper is well written, and the remarkable difference in symptoms
reported by the celiac patients when exposed to Tm appears indeed encouraging
and worth of further studies.
Level of interest: An article of importance in its field
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests
Reviewer's report
Title:Search for atoxic cereals: a phase II, single blind, cross-over study on
safety of a single dose of Triticum monococcum in patients with celiac disease
Version: 1Date:23 February 2013
Reviewer: Stefano S Guandalini
Reviewer's report:
This study aims at assessing the safety of an ancient grain, Triticum
monococcum, in celiac patients.
This author's main criticism is centered on the choice of the intestinal
permeability (IP) test as a valid measure of the effect of acute gluten toxicity in
celiac patients.
In fact, contrary to what is stated ("a method to assess changes of small
intestinal permeability that is known to increase in CD patients exposed to
gluten[11]", IP is not an accepted parameter to evaluate the toxicity of gluten in
celiacs. In fact, reference 11 simply reports, among other elements, the fact that
2 previous studies only (conducted in 1982 and 1991) showed that gluten
induced an acute change in IP. Of note, the 1991 study (Ref.: Greco L, D'Adamo
G, Truscelli A, Parrilli G, Mayer M, Budillon G. Intestinal
permeability after single dose gluten challenge in coeliac disease. Arch Dis
Child. 1991 Jul;66(7):870-2.) uses a dose of gluten (50g) that is 20 times higher
than that employed in the present study!
In other words, the design of the study was doomed to fail to show any benefit of
the ancient grain compared to 2.5g of gluten.
For the rest, the paper is well written, and the remarkable difference in symptoms
reported by the celiac patients when exposed to Tm appears indeed encouraging
and worth of further studies.
Level of interest: An article of importance in its field
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests
Please review this paper.
user
Reviewer's report
Title:Search for atoxic cereals: a phase II, single blind, cross-over study on
safety of a single dose of Triticum monococcum in patients with celiac disease
Version: 1Date:23 February 2013
Reviewer: Stefano S Guandalini
Reviewer's report:
This study aims at assessing the safety of an ancient grain, Triticum
monococcum, in celiac patients.
This author's main criticism is centered on the choice of the intestinal
permeability (IP) test as a valid measure of the effect of acute gluten toxicity in
celiac patients.
In fact, contrary to what is stated ("a method to assess changes of small
intestinal permeability that is known to increase in CD patients exposed to
gluten[11]", IP is not an accepted parameter to evaluate the toxicity of gluten in
celiacs. In fact, reference 11 simply reports, among other elements, the fact that
2 previous studies only (conducted in 1982 and 1991) showed that gluten
induced an acute change in IP. Of note, the 1991 study (Ref.: Greco L, D'Adamo
G, Truscelli A, Parrilli G, Mayer M, Budillon G. Intestinal
permeability after single dose gluten challenge in coeliac disease. Arch Dis
Child. 1991 Jul;66(7):870-2.) uses a dose of gluten (50g) that is 20 times higher
than that employed in the present study!
In other words, the design of the study was doomed to fail to show any benefit of
the ancient grain compared to 2.5g of gluten.
For the rest, the paper is well written, and the remarkable difference in symptoms
reported by the celiac patients when exposed to Tm appears indeed encouraging
and worth of further studies.
Level of interest: An article of importance in its field
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests
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