Efficacy of FODMAP Elimination and Subsequent Blinded Placebo-Controlled Provocations in a Randomised Controlled Study in Patients with Ulcerative Colitis in Remission and Symptoms of Irritable Bowel Syndrome: A Feasibility Study
, Jeanette Sørensen 3, Johannes Riis 1, Tine S. Ovesen 3,4, Peter Leutscher 1,2, Suzette Sørensen 1,2, Julie K. Knudsen 1, Caspar Bundgaard-Nielsen 1, Jeanette Ejstrup 3, Ann-Maria Jensen 1, Mette Borre 5 and Anne L. Krarup 2,3,6Round 1
Reviewer 1 Report
This is an interesting study in which the authors have tested elimination and subsequent reintroduction of FODMAPs in patients with IBS symptoms and compared the severity of IBS symptoms, pain, bloating, and quality of life. Though the recruitment of participants was challenging in the current study, the authors successfully showed the possibility of performing a randomized controlled study for testing food intolerance with blinding of the Low FODMAP diet. However, I have a few minor comments regarding the manuscript/study.
- There are many typos throughout the manuscript. e.g., in line 79, colonoscopy is misspelled; in line 84 there is no space between 'above' and 'mentioned'; in line 102 'underwent' is written in a smaller font; in line 174 QOL is written while at other places it is written as QoL, and so on.
- Did the authors collect sex-dependent data?
Author Response
Dear reviewer
Thank you for the kind receipt of our paper. We appreciate the time and effort put into reading and commenting on our manuscript. The points you have raised have been addressed as detailed below, and changes are highlighted directly in the text using track changes.
There are many typos throughout the manuscript. e.g., in line 79, colonoscopy is misspelled; in line 84 there is no space between 'above' and 'mentioned'; in line 102 'underwent' is written in a smaller font; in line 174 QOL is written while at other places it is written as QoL, and so on. The typos are now corrected
Did the authors collect sex-dependent data? Yes, but due to the small sample size we do not find et relevant to report them.
Respectfully yours
Dorte Melgaard
Reviewer 2 Report
This is a very well-written and interesting paper. It is educational and, in my opinion, provides important information. I just have a few questions.
I know you addressed the issue of enrollment numbers but, DO you think you should include a power analysis? It isn’t difficult to do and solidifies your goal. In addition, you have actually drawn negative conclusions.
My guess is the study was too small and too short to demonstrate your outcome statistically. In this type study subject, however, even information that trends is helpful considering many patients want nonpharmacologic relief and there are no contraindications or side effects to the treatment (Low FODMAP diet)
Do you think BMI is more helpful than wt?
Race of subjects?
Only 19 patients? Why not study IBS rather than silent UC and IBS patients? Especially considering the primary objective.
Author Response
Dear reviewer
Thank you for the kind receipt of our paper. The points you have raised have been addressed as detailed below, and changes are highlighted directly in the text using track changes.
I know you addressed the issue of enrollment numbers but, DO you think you should include a power analysis? The power analysis is added - l. 87.
Do you think BMI is more helpful than wt? The BMI or the wt seems not to be very relevant in this study
Race of subjects? Caucasian - added table 2
Only 19 patients? Why not study IBS rather than silent UC and IBS patients? Especially considering the primary objective. More studies includes patients with IBS, but only very few studies focus on patients with UC and IBS
