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      Optimizing educational methods for the low FODMAP diet in disorders of gut–brain interaction: A feasibility randomized controlled trial

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          Abstract

          Background

          A diet low in fermentable oligo‐saccharides, di‐saccharides, mono‐saccharides and polyols (low FODMAP diet) is complex and clinical effectiveness is achieved with dietitian‐led education, although dietitian availability in clinical practice varies. This study aimed to assess the feasibility of undertaking a trial to investigate the clinical and cost‐effectiveness of different education delivery methods of the low FODMAP diet in patients with disorders of gut–brain interaction (DGBI).

          Methods

          In this feasibility randomized controlled trial, patients with DGBI requiring the low FODMAP diet were randomized to receive one of the following education delivery methods: booklet, app, or dietitian. Recruitment and retention rates, acceptability, symptoms, stool output, quality of life, and dietary intake were assessed.

          Key Results

          Fifty‐one patients were randomized with a recruitment rate of 2.4 patients/month and retention of 48 of 51 (94%). Nobody in the booklet group strongly agreed that this education delivery method enabled them to self‐manage symptoms without further support, compared to 7 of 14 (50%) in the dietitian group ( p = 0.013). More patients reported adequate relief of symptoms in the dietitian group (12, 80%) compared with the booklet group (7, 39%; p = 0.026), but not when compared to the app group (10, 63%, p > 0.05). There was a greater decrease in the IBS‐SSS score in the dietitian group (mean −153, SD 90) compared with the booklet group (mean −90, SD 56; p = 0.043), but not when compared with the app group (mean −120, SD 62; p = 0.595).

          Conclusions & Inferences

          Booklets were the least acceptable education delivery methods. Dietitian‐led consultations led to high levels of clinical effectiveness, followed by the app, while the dietitian was superior to booklets alone. However, an adequately powered clinical trial is needed to confirm clinical effectiveness of these education delivery methods.

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          Most cited references54

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          Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis.

          Many cross-sectional surveys have reported the prevalence of irritable bowel syndrome (IBS), but there have been no recent systematic review of data from all studies to determine its global prevalence and risk factors. MEDLINE, EMBASE, and EMBASE Classic were searched (until October 2011) to identify population-based studies that reported the prevalence of IBS in adults (≥15 years old); IBS was defined by using specific symptom-based criteria or questionnaires. The prevalence of IBS was extracted for all studies and based on the criteria used to define it. Pooled prevalence, according to study location and certain other characteristics, odds ratios (ORs), and 95% confidence intervals (CIs) were calculated. Of the 390 citations evaluated, 81 reported the prevalence of IBS in 80 separate study populations containing 260,960 subjects. Pooled prevalence in all studies was 11.2% (95% CI, 9.8%-12.8%). The prevalence varied according to country (from 1.1% to 45.0%) and criteria used to define IBS. The greatest prevalence values were calculated when ≥3 Manning criteria were used (14%; 95% CI, 10.0%-17.0%); by using the Rome I and Rome II criteria, prevalence values were 8.8% (95% CI, 6.8%-11.2%) and 9.4% (95% CI, 7.8%-11.1%), respectively. The prevalence was higher for women than men (OR, 1.67; 95% CI, 1.53-1.82) and lower for individuals older than 50 years, compared with those younger than 50 (OR, 0.75; 95% CI, 0.62-0.92). There was no effect of socioeconomic status, but only 4 studies reported these data. The prevalence of IBS varies among countries, as well as criteria used to define its presence. Women are at slightly higher risk for IBS than men. The effects of socioeconomic status have not been well described. Copyright © 2012 AGA Institute. Published by Elsevier Inc. All rights reserved.
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            Sample size of 12 per group rule of thumb for a pilot study

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              The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress.

              The clinical assessment and investigation of irritable bowel syndrome would be greatly facilitated by the introduction of a simple, easy to use severity scoring system. Such a system, developed in our department over a number of years, has been submitted to validation in a total of 141 patients and 40 healthy controls. The system, incorporating pain, distension, bowel dysfunction and quality of life/global well-being, was assessed for its ability to reliably score patients previously classified as mild, moderate or severe. The reproducibility and sensitivity to change of the system was also assessed. The maximum achievable score was 500. Mild, moderate and severe cases were indicated by scores of 75 to 175, 175 to 300 and > 300 respectively. Controls scored below 75 and patients scoring in this range can be considered to be in remission. There was a highly significant difference between controls and patients as a whole (P = 0.0001) as well as significant differences (P < 0.01) between all severity categories. Scores repeated within 24 h were very reproducible and sensitivity to change was also extremely good (P < 0.001) with a change of 50 reliably indicating improvement. These results suggest that this scoring system should prove to be a valuable instrument in helping to meet the many challenges offered by irritable bowel syndrome.
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                Author and article information

                Contributors
                (View ORCID Profile)
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                Journal
                Neurogastroenterology & Motility
                Neurogastroenterology Motil
                Wiley
                1350-1925
                1365-2982
                October 2023
                July 21 2023
                October 2023
                : 35
                : 10
                Affiliations
                [1 ] Department of Nutritional Sciences King's College London London UK
                [2 ] Department of Nutrition and Dietetics Guy's and St Thomas' NHS Foundation Trust London UK
                Article
                10.1111/nmo.14640
                37480191
                eac411cb-8f64-44a5-a043-dcb11a14dac5
                © 2023

                http://creativecommons.org/licenses/by/4.0/

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