Irritable Bowel Syndrome Clinical Trial
Official title:
A Feasibility Study on Different Health Education Delivery Methods for a Low Fermentable Carbohydrate (FODMAP) Diet in Patients With Functional Bowel Disorders
There is evidence for the use of a diet low in short chain fermentable carbohydrates (low
FODMAP diet) in the management of functional gut symptoms, such as abdominal pain and
bloating. However, the provision of advice on the low FODMAP diet can be challenging due to
limited resources and the need for a dietitian with expertise in the low FODMAP diet. The aim
of this study is to assess the feasibility in terms of recruitment and retention in planning
a future trial. The purpose of the future trial will be to investigate the clinical and cost
effectiveness, as well as the acceptability of different education methods of the low FODMAP
diet for the treatment of IBS.
To date, there are no studies on the implementation of the low FOMDAP diet using a mobile app
or leaflets in the education of the low FODMAP diet. Therefore, a feasibility study design
was chosen in order to obtain key data on recruitment and retention rates at each study
group.
A low FODMAP diet includes FODMAP restriction, FODMAP re-introduction and FODMAP
personalisation. This study will focus on FODMAP restriction whereby foods high in FODMAPs
are avoided for 4 weeks.
Patients with IBS will be recruited from primary and secondary care centres.
STUDY GROUPS
Group 1: 2 x Booklets produced produced by the Department of Nutrition and Dietetic in Guy's
& St Thomas' NHS Foundation Trust, and the Diabetes and Nutritional Sciences Division at
King's College London. These booklets have been produced by dietitians and are commonly used
in clinical practice across the UK. They contain the following information:
Group 2: Patients will be asked to download an application on their mobile phones or tablets.
This application has been produced by dietitians from the Department of Nutrition and
Dietetic in Guy's & St Thomas' NHS Foundation Trust, and the Diabetes and Nutritional
Sciences Division at King's College London.
Group 3:Patients will attend a clinic visit for a one-to-one consultation with a dietitian.
As per current clinical practice, the initial visit will last for 1 hour.
PRIMARY OBJECTIVE The primary objective is to estimate recruitment and retention rates of
patients with IBS receiving different education delivery methods of the low FODMAP diet.
SAMPLE SIZE As this is a feasibility study, a formal sample size calculation is not
appropriate. For such feasibility studies, sample sizes between 24 and 50 have been
recommended. Therefore, for this study, a total sample size of 45 was chosen (15 patients per
group). Previous work indicates an approximately 12% attrition rate and, therefore, the final
sample size will be 50 patients.
ANALYSIS Descriptive statistics such as mean values, standard deviations (SD) for continuous
variables, and counts (percentages) and confidence intervals (CI) for categorical variables
will be calculated. To assess recruitment and retention rates the following will be recorded:
number of people directly contacting the researchers for the study, number of participants
pre-screened and screened, number of participants randomised, number of drop-outs.
ETHICS AND REGULATORY APPROVALS The trial will be conducted in compliance with the principles
of the Declaration of Helsinki (1996), the principles of Good Clinical Practice. Ethical
approval for this study has been granted by an NRES Committee London.
DATA HANDLING
The Chief Investigator will act as custodian for the trial data. The following guidelines
will be strictly adhered to:
1. Patient data will be anonymised
2. All trial data will be stored on a password protected computer and limited to authorised
study personnel
3. All records and samples will be stored in a secure environment
4. All trial data will be stored in line with the Data Protection Act
5. Data and samples will be securely stored for 5 years after the study has ended and may
be used for further in depth analysis
6. Data may be accessed by regulatory authorities for audit purposes
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