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
NCT number | NCT03694223 |
Other study ID # | 206464 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 3, 2016 |
Est. completion date | October 25, 2018 |
Verified date | July 2018 |
Source | King's College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 51 |
Est. completion date | October 25, 2018 |
Est. primary completion date | October 25, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Men and women aged 18 or over with IBS, functional diarrhoea or functional bloating based on Rome IV criteria who do not have a major medical condition (diabetes, psychiatric or current eating disorders), gastrointestinal disease (e.g. inflammatory bowel disease, coeliac disease) or history of previous GI surgery, except cholecystectomy and haemorrhoidectomy 2. Individuals with no adequate relief of their symptoms at baseline, as well as those with frequency of abdominal pain or discomfort for 1 or more days/week. 3. Individuals with a BMI of 18.5 kgm2 or more. 4. Individuals able to give informed consent 5. Individuals able to understand English 6. Individuals able to read English 7. Individuals with access to Internet 8. Individuals with smartphone with Android or IOS (Apple) software who are able to download apps. Exclusion Criteria: 1. Females who report to be pregnant or lactating 2. Individuals with constipation predominant IBS (IBS-C) based on the Rome IV criteria 3. Consumption of antibiotics, in the last 4 weeks prior to the study 4. Individuals with additional specific dietary needs (based on the dietitian's judgment) 5. Individuals with multiple food allergies 6. Individuals who have participated in other trials with investigational products within 3 months prior to screening |
Country | Name | City | State |
---|---|---|---|
United Kingdom | King's College London | London |
Lead Sponsor | Collaborator |
---|---|
King's College London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | RECRUITMENT RATE | Recruitment rate of patients receiving different education delivery methods of the low FODMAP diet. | Baseline visit (Day 0) | |
Primary | RETENTION RATE (overall and within each study group) | Retention rate of patients receiving different education delivery methods of the low FODMAP diet. | Follow-up visit (week 4) | |
Secondary | Compliance rates to the diet | Compliance rates to the diet within the study groups assessed via a 7day food and drink diary | Follow-up visit (week 4) | |
Secondary | Satisfaction over the education delivery methods received | Satisfaction over the education methods and diet, assessed via 5-point Likert scales (1=Strongly Agree, 2=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree) | Baseline (Day 0) and Follow-up visit (week 4) | |
Secondary | Appropriateness of the education methods received in each study group | Perceived appropriateness of the education methods, assessed via 5-point Likert scales (1=Strongly Agree, 2=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree) | Baseline (Day 0) and Follow-up visit (week 4) | |
Secondary | Perceived fit of the education delivery methods within the NHS | Assessed via a 5-point Likert scale (1=Strongly Agree, 2=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree) | Follow-up visit (week 4) | |
Secondary | Willingness of participants being assigned to the study groups using a multiple choice questionnaire. | Assessed via a question on whether they would like to have been randomised to a different group (Yes/No) | Follow-up visit (week 4) | |
Secondary | Gastrointestinal symptom severity | Validated Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) questionnaire. The questionnaire includes four VAS items evaluating abdominal pain frequency and intensity, abdominal distension, satisfaction with bowel habit, and quality of life. Scores are then added up; scoring allows categorisation of patients into mild (75-174), moderate (175-300) and severe (>300) cases, with a maximum achievable severity score of 500 points. A minimal clinically important difference of a 50-point reduction in score allows meaningful interpretation of score change over time. | Baseline (Day 0) and Follow-up visit (week 4) | |
Secondary | Health-related quality of life in irritable bowel syndrome | Validated Irritable Bowel Syndrome-Quality of Life (IBS-QoL) questionnaire. Each item utilises a 5-point Likert response scale, which is transformed to a 0-100 point scale and subscale scores are then calculated (dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual, relationships). A total score can be calculated by summing the subscale scores. A score of 100 denotes maximum QOL for subscales and the total score. | Baseline (Day 0) and Follow-up visit (week 4) | |
Secondary | Gastrointestinal symptoms experienced | Assessed using Gastrointestinal Symptom Rating Scale (GSRS). Gastrointestinal symptoms (Abdominal discomfort or pain, Heartburn, Acid reflux, nausea, abdominal gurgling, bloating, burping, flatulence, constipation, diarrhoea, loos stools, hard stools, urgency, incomplete evacuation, tiredness, overall symptoms) are rated in a 4-point Likert scale (0=Absent, 1=Mild, 2=Moderate, 3=Severe). Descriptive and inferential statistical results are presented for each individual symptom seperately. | Baseline and follow-up visitBaseline (Day 0) and Follow-up visit (week 4) | |
Secondary | Adequate relief of symptoms | Assessed using the "adequate relief of IBS symptoms" question (IBS-AR). The outcome is dischotomous (Yes/No) and counts/percentages that have reported adequate relief ("Yes") will be presented. | Baseline (Day 0) and Follow-up visit (week 4) | |
Secondary | Estimates of the parameters required for calculation of the sample size for a future larger study | The results of this study will be used to inform the sample size calculation of a future larger study if needed. The outcome that will be used for the sample size calculation depends on the which the primary outcome of the future study will be. The mean and standard deviation generated from this study will be used for the sample size of the future trial. | Screening (Week -1), Baseline (Day 0) and Follow-up visit (week 4) |
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