A 5Ad Dietary Protocol for Functional Bowel Disorders

Comment 1

I reviewed the   above-mentioned manuscript from Ibrahim et al. evaluating the effect of a new   dietary protocol on abdominal symptoms in 22 patients with functional bowel   disorders. The concept of the 5AD dietary protocol is shows advantages in   comparison to the existing low FODMAP diet as it is less restrictive, avoids   malnutrition (ensures adequate calcium intake), simple to follow and less   costly. Interestingly, this new diet significantly improved abdominal   symptoms independent of the IBS subtypes (predominant constipation or   diarrhoea). This is a short-term trial studying effects of a 7-day balanced   diet in IBS patients consuming at least one item of the 5 food groups,   including low-lactose dairy products, around 1 kilo intake of fruit and   vegetables, but restricted to fruits with a equimolar fructose to glucose   ratio. The authors pointed out three interesting advantages of the diet: -   Significant improvement of a wide range of functional abdominal symptoms. -   Normalisation of bowel function in predominant constipated and diarrheal   patients. - Potential of long-term adherence due to easy to follow   instructions. This is a novel and interesting approach towards dietary   treatment of FBD and is of interest to the readers of nutrients.

Response

We fully appreciate the evaluation of   the manuscript by the reviewer, and we would like to thank the reviewer for   the valuable comments above and emphasizing the novelty of the approach.

Comment 2

The manuscript is   well written, scientific and clearly structured. The limitations of the study   were clearly presented.

Response

We would like to thank the reviewer   for this comment as well.

Comment 3

Further studies   comparing for example 5Ad dietary protocol with low FODMAP are necessary.

Response

This original research was carried out to explore the utility of   the newly developed 5Ad Dietary Protocol and was intended as a preliminary   study; therefore, we do agree with the reviewer that more studies are needed,   particularly randomized clinical trials. We planned to conduct an RCT with   the 5Ad Dietary Protocol vs the low FODMAP diet as well as the NICE   guidelines in collaboration with the regional Clinical Trial Unit (CTU),   Norwich, United Kingdom, and we have already established the necessary communication   for this purpose.

Comment 4

However, there are   just some minor points of criticism that should be referred in the revised   manuscript. Minor remarks 1) It is not mentioned how the eligibility criteria   “no underlying pathology” was assessed.

Response

A screening questionnaire was the basis of the participant   eligibility, and therein the participants were asked whether they have been   formally diagnosed with IBS and whether any associated pathologies had been   identified. Thus, it was a self-reported assessment, which is now clarified   in Box 3.

Comment 5

2) A more detailed   description of the 5Ad Dietary Protocol and how the participants were   instructed is missing in the methological section.

At this point of time, we do feel that there is a potential for intellectual   property rights associated with the 5Ad Dietary Protocol and therefore the participants   were asked to maintain the confidentiality of the protocol. The 5Ad Dietary   Protocol was designed solely by the authors of this manuscript, and although   it might prove difficult to patent a dietary protocol, we would like to   conduct more studies before we fully publish the details of the protocol. However,   if the editor and the reviewers think this is essential before publication,   we are happy to upload the detailed instructions of the protocol to share it   with the reviewers and the editor and seek their advice on whether the   details should be published as supplementary materials, or whether we are able   to withhold until investigating the intellectual property matter.

Comment 6

3) No information   on the diagnosis of the other 50% of the patients were given.

Half of the participants were self-reported as formally diagnosed   with IBS based on the screening questionnaire and the remaining were not   formally diagnosed with IBS. However, the eligibility criteria were more   vigorous than the Rome IV criteria and were meant to be more inclusive for   those who have been silently suffering from functional bowel disorders rather   than focusing only on a limited section of the population who have the   opportunity to be diagnosed as IBS patients. The Rome IV criteria applies to   the last 6 months before diagnosis, while we included those who have been   suffering for at least a year; indeed most participants in this study have   been suffering with abdominal symptoms for more than 5 years, according to   the screening questionnaire.

Comment 7

4) Figure 3 and 4   labelling – the letters are to small

The figures have been resized so that the labels are now more   visible.

Comment 8

5) The   introduction could be shortened.

We have revisited the introduction and we shortened as   recommended. All changes are made using the MS word Review function and can   be seen in the new draft.

Comment 9

6) The supplement   with the meal examples were missing.

Apologies for this error, and the example meals are now provided   in a file named: Supplementary_1 meal examples. Providing the meal examples   may also contribute the discussion of our response to comment 5.

Comment 10

7) Pages are   missing in the citation of ref 33,48 and 50

The page numbers have now been added to the above citations, and   where there was no page number available yet, a DOI has been added.

Comment 1

This study was conducted to assess the potential benefit of 5Ad   Dietary Protocol i subject with FBDs. Overall it showed promising findings   regarding its efficacy in reducing a wide 168 range of symptoms associated   with FBDs and  a significant improvement was shown in abdominal pain 169   as well as all other assessed abdominal symptoms scores

Response

We would like to thank the reviewer for evaluating   the manuscript and pointing out the significance of the findings and the   improvements shown in a wide range of abdominal symptoms. Indeed, it was very   interesting to see these findings and to understand the importance of food   ingredients in the aetiology of functional bowel disorders.  It is very likely that effects of food   ingredients on bowel function are also relevant to extra-intestinal diseases   mediated by their direct effect on gut barrier function but this remains to   be elucidated in further research.

Comment 2

the number of tested subject is of concern. Please provide a justification   that n=22 subjects is an optimal group to draw the conclusion.

Response

Mathematically, the larger the sample size, the higher   the potential to find a significant difference and therefore, a larger sample   size is normally required to make sure that the study is not underpowered and   to avoid type II error. However, these highly significant findings were   observed with a relatively small sample size, therefore demonstrating   substantial efficacy of the protocol. From this study, we have also learned   about the power required for further randomized clinical trials in order to   test the protocol against the mainstream dietary therapies such as the low   FODMAP diet and NICE guidelines. We have also developed the methodology for   an inclusive evaluation of the abdominal symptoms, and we are working on a   novel overall index too.