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:4 March 2013
Reviewer: Jonas Ludvigsson
Reviewer's report:
Search for ataxic cereals
single-blind cross-over study - Triticum Monococcum (™) in celiac disease
Thansk for allowing me to read this study.
The researchers aimed to investigate the toxicity of a single dose of gluten of ™.
How do you motivate that one dose of ™-gluten would be relevant for safety
testing? Is it not likely that more than one dose would be necessary to see
complications from exposure to this kind of gluten?
The 12 CD patients in this study had been GFD-adherent for >=12 moths. How
did you test their adherence=
HPLC should be explained (not abbreviated only) in the abstract.
"according to the HWO scale". WhatWHO scale?
In the abstract results, I suggest you present data in the same order as in the
abstract-methods (rice, amygluten and then ™).
I suggest you add p-values, I expect the urinary L/R ratio to be >0.05 [but please
give exact p-value], but the number of GI adverse events to be <0.05 (give exact
value).
Why do you not at all mention the newly diagnosed celiac patients and the
healthy controls in the abstract?
I agree with the conclusion of the abstract.
Background
I suggest a reference to support that GFD is the only available treatment.
I think the background is reasonable, and it seems that there are good reasons to
evaluate ™.
Why did you choose to expose participants to 2.5g protein extract. Why is this a
reasonable amount? How much "bread" does 2.5g protein extract correspond to?
Phase I - please describe the phase 1 studies with a 1-2 sentences.
Methods
You required negative TTG and/or EMA during GFDin study participants but then
write in the results that one patient had positive TTG/EMA?
How did you evaluate strict dietary adherence?
Add a reference to support the WHO scale.
Why did you include 12 patients, and not 8 or 20? Did you perform any power
calculations prior to the study?
Were values normally distributed since you chose to present means +- SD:s and
not medians and range?
The ethics approval is well described
Results
Validation study, please give p.values when you compare groups.
The description of Table 1 is insufficient, what is actually "0" and "2" in the GFD
column?
Discussion
OK. I agree with the authors that it is difficult to draw any firm conclusions from
this dataset due to the very small number of study participants.
References
The authors may consider to read and cite the recent paper:
Immunogenicity of monococcum wheat in celiac patients.
Gianfrani C, Maglio M, Rotondi Aufiero V, Camarca A, Vocca I, Iaquinto G,
Giardullo N, Pogna N, Troncone R, Auricchio S, Mazzarella G.
Am J Clin Nutr. 2012 Dec;96(6):1339-45.
Minor comment:
Consider re-writing:
"Challenge with different proteins was carried in 3 separate occasions at time….
"
to
"Challenge with different proteins was carried out on 3 separate occasions at
time…. "
"As a consequence no conclusion can be drown [DRAWN] on the safety of acute
administration of Tm on CD patients"
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: Yes, and I have assessed the statistics in my report.
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:4 March 2013
Reviewer: Jonas Ludvigsson
Reviewer's report:
Search for ataxic cereals
single-blind cross-over study - Triticum Monococcum (™) in celiac disease
Thansk for allowing me to read this study.
The researchers aimed to investigate the toxicity of a single dose of gluten of ™.
How do you motivate that one dose of ™-gluten would be relevant for safety
testing? Is it not likely that more than one dose would be necessary to see
complications from exposure to this kind of gluten?
The 12 CD patients in this study had been GFD-adherent for >=12 moths. How
did you test their adherence=
HPLC should be explained (not abbreviated only) in the abstract.
"according to the HWO scale". WhatWHO scale?
In the abstract results, I suggest you present data in the same order as in the
abstract-methods (rice, amygluten and then ™).
I suggest you add p-values, I expect the urinary L/R ratio to be >0.05 [but please
give exact p-value], but the number of GI adverse events to be <0.05 (give exact
value).
Why do you not at all mention the newly diagnosed celiac patients and the
healthy controls in the abstract?
I agree with the conclusion of the abstract.
Background
I suggest a reference to support that GFD is the only available treatment.
I think the background is reasonable, and it seems that there are good reasons to
evaluate ™.
Why did you choose to expose participants to 2.5g protein extract. Why is this a
reasonable amount? How much "bread" does 2.5g protein extract correspond to?
Phase I - please describe the phase 1 studies with a 1-2 sentences.
Methods
You required negative TTG and/or EMA during GFDin study participants but then
write in the results that one patient had positive TTG/EMA?
How did you evaluate strict dietary adherence?
Add a reference to support the WHO scale.
Why did you include 12 patients, and not 8 or 20? Did you perform any power
calculations prior to the study?
Were values normally distributed since you chose to present means +- SD:s and
not medians and range?
The ethics approval is well described
Results
Validation study, please give p.values when you compare groups.
The description of Table 1 is insufficient, what is actually "0" and "2" in the GFD
column?
Discussion
OK. I agree with the authors that it is difficult to draw any firm conclusions from
this dataset due to the very small number of study participants.
References
The authors may consider to read and cite the recent paper:
Immunogenicity of monococcum wheat in celiac patients.
Gianfrani C, Maglio M, Rotondi Aufiero V, Camarca A, Vocca I, Iaquinto G,
Giardullo N, Pogna N, Troncone R, Auricchio S, Mazzarella G.
Am J Clin Nutr. 2012 Dec;96(6):1339-45.
Minor comment:
Consider re-writing:
"Challenge with different proteins was carried in 3 separate occasions at time….
"
to
"Challenge with different proteins was carried out on 3 separate occasions at
time…. "
"As a consequence no conclusion can be drown [DRAWN] on the safety of acute
administration of Tm on CD patients"
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: Yes, and I have assessed the statistics in my report.
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:4 March 2013
Reviewer: Jonas Ludvigsson
Reviewer's report:
Search for ataxic cereals
single-blind cross-over study - Triticum Monococcum (™) in celiac disease
Thansk for allowing me to read this study.
The researchers aimed to investigate the toxicity of a single dose of gluten of ™.
How do you motivate that one dose of ™-gluten would be relevant for safety
testing? Is it not likely that more than one dose would be necessary to see
complications from exposure to this kind of gluten?
The 12 CD patients in this study had been GFD-adherent for >=12 moths. How
did you test their adherence=
HPLC should be explained (not abbreviated only) in the abstract.
"according to the HWO scale". WhatWHO scale?
In the abstract results, I suggest you present data in the same order as in the
abstract-methods (rice, amygluten and then ™).
I suggest you add p-values, I expect the urinary L/R ratio to be >0.05 [but please
give exact p-value], but the number of GI adverse events to be <0.05 (give exact
value).
Why do you not at all mention the newly diagnosed celiac patients and the
healthy controls in the abstract?
I agree with the conclusion of the abstract.
Background
I suggest a reference to support that GFD is the only available treatment.
I think the background is reasonable, and it seems that there are good reasons to
evaluate ™.
Why did you choose to expose participants to 2.5g protein extract. Why is this a
reasonable amount? How much "bread" does 2.5g protein extract correspond to?
Phase I - please describe the phase 1 studies with a 1-2 sentences.
Methods
You required negative TTG and/or EMA during GFDin study participants but then
write in the results that one patient had positive TTG/EMA?
How did you evaluate strict dietary adherence?
Add a reference to support the WHO scale.
Why did you include 12 patients, and not 8 or 20? Did you perform any power
calculations prior to the study?
Were values normally distributed since you chose to present means +- SD:s and
not medians and range?
The ethics approval is well described
Results
Validation study, please give p.values when you compare groups.
The description of Table 1 is insufficient, what is actually "0" and "2" in the GFD
column?
Discussion
OK. I agree with the authors that it is difficult to draw any firm conclusions from
this dataset due to the very small number of study participants.
References
The authors may consider to read and cite the recent paper:
Immunogenicity of monococcum wheat in celiac patients.
Gianfrani C, Maglio M, Rotondi Aufiero V, Camarca A, Vocca I, Iaquinto G,
Giardullo N, Pogna N, Troncone R, Auricchio S, Mazzarella G.
Am J Clin Nutr. 2012 Dec;96(6):1339-45.
Minor comment:
Consider re-writing:
"Challenge with different proteins was carried in 3 separate occasions at time….
"
to
"Challenge with different proteins was carried out on 3 separate occasions at
time…. "
"As a consequence no conclusion can be drown [DRAWN] on the safety of acute
administration of Tm on CD patients"
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: Yes, and I have assessed the statistics in my report.
Declaration of competing interests:
I declare that I have no competing interests
assistant