Irritable Bowel SyndromeNCT03694223
Health Education Delivery Methods for a Low Fermentable Carbohydrate Diet in Patients With Functional Bowel Disorders
A study testing Health education delivery methods in people with Irritable Bowel Syndrome and Functional Diarrhea, run by King's College London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome, Functional Diarrhea, Functional Bowel Disorder
- What is being tested?
- Health education delivery methods
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Jan 2016to 25 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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.
- Individuals with a BMI of 18.5 kgm2 or more.
- Individuals able to give informed consent
- Individuals able to understand English
- Individuals able to read English
- Individuals with access to Internet
- Individuals with smartphone with Android or IOS (Apple) software who are able to download apps.
Who cannot join
- Females who report to be pregnant or lactating
- Individuals with constipation predominant IBS (IBS-C) based on the Rome IV criteria
- Consumption of antibiotics, in the last 4 weeks prior to the study
- Individuals with additional specific dietary needs (based on the dietitian's judgment)
- Individuals with multiple food allergies
- Individuals who have participated in other trials with investigational products within 3 months prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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:
- Patient data will be anonymised
- All trial data will be stored on a password protected computer and limited to authorised study personnel
- All records and samples will be stored in a secure environment
- All trial data will be stored in line with the Data Protection Act
- Data and samples will be securely stored for 5 years after the study has ended and may be used for further in depth analysis
- Data may be accessed by regulatory authorities for audit purposes
- Being tested
- Health education delivery methods
- Keywords
- FODMAP, DIET, BLOATING
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health education delivery methodsOther
| Study group | Role | What they receive |
|---|---|---|
| Booklets | Experimental | Health education delivery method: Booklet. Patients will be given 2 leaflets on the low FOMDAP diet 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. Receives: Other: Health education delivery methods |
| Mobile application | Experimental | Health education delivery method: Mobile application. 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. Receives: Other: Health education delivery methods |
| One to one consultation with dietitian | Active comparator | Health education delivery method:One-to-one consultation with dietitian. 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. During the visit, tailored information on the low FOMDAP diet will be given to match patients' individual needs. During the visit, either the leaflets (used in group 1) or the application (used in group 2) will be used to facilitate the visit. The choice of using the leaflets or the app during the visit will be based on the dietitian's judgment based on the patients' needs. Receives: Other: Health education delivery methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
RECRUITMENT RATE
Recruitment rate of patients receiving different education delivery methods of the low FODMAP diet.
Measured: Baseline visit (Day 0)
RETENTION RATE (overall and within each study group)
Retention rate of patients receiving different education delivery methods of the low FODMAP diet.
Measured: Follow-up visit (week 4)
Secondary outcomes (10)
Compliance rates to the diet
Compliance rates to the diet within the study groups assessed via a 7day food and drink diary
Measured: Follow-up visit (week 4)
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)
Measured: Baseline (Day 0) and Follow-up visit (week 4)
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)
Measured: Baseline (Day 0) and Follow-up visit (week 4)
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)
Measured: Follow-up visit (week 4)
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)
Measured: Follow-up visit (week 4)
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.
Measured: Baseline (Day 0) and Follow-up visit (week 4)
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.
Measured: Baseline (Day 0) and Follow-up visit (week 4)
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.
Measured: Baseline and follow-up visitBaseline (Day 0) and Follow-up visit (week 4)
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.
Measured: Baseline (Day 0) and Follow-up visit (week 4)
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.
Measured: Screening (Week -1), Baseline (Day 0) and Follow-up visit (week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start3 Jan 2016
- Primary completion25 Oct 2018
- Study completion25 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miranda Lomer, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03694223
- Sponsor's protocol ID
- 206464
- Status last verified
- Jul 2018
- First submitted
- 23 Jul 2018
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study on Different Health Education Delivery Methods for a Low Fermentable Carbohydrate (FODMAP) Diet in Patients With Functional Bowel Disorders
- ClinicalTrials.gov ID
- NCT03694223
- Acronym / sponsor ID
- 206464
- Keywords
- FODMAP, DIET, BLOATING
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 3 Jan 2016 (actual)
- Primary completion
- 25 Oct 2018 (actual)
- Study completion
- 25 Oct 2018 (actual)
- First posted
- 3 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Patient data will be anonymised
- All trial data will be stored on a password protected computer and limited to authorised study personnel
- All records and samples will be stored in a secure environment
- All trial data will be stored in line with the Data Protection Act
- Data and samples will be securely stored for 5 years after the study has ended and may be used for further in depth analysis
- Data may be accessed by regulatory authorities for audit purposes
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Booklets | Experimental | Other: Health education delivery methodsHealth education delivery method: Booklet. Patients will be given 2 leaflets on the low FOMDAP diet 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. |
| Mobile application | Experimental | Other: Health education delivery methodsHealth education delivery method: Mobile application. 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. |
| One to one consultation with dietitian | Active comparator | Other: Health education delivery methodsHealth education delivery method:One-to-one consultation with dietitian. 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. During the visit, tailored information on the low FOMDAP diet will be given to match patients' individual needs. During the visit, either the leaflets (used in group 1) or the application (used in group 2) will be used to facilitate the visit. The choice of using the leaflets or the app during the visit will be based on the dietitian's judgment based on the patients' needs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- 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.
- Individuals with a BMI of 18.5 kgm2 or more.
- Individuals able to give informed consent
- Individuals able to understand English
Key exclusion criteria (6 listed)
- Females who report to be pregnant or lactating
- Individuals with constipation predominant IBS (IBS-C) based on the Rome IV criteria
- Consumption of antibiotics, in the last 4 weeks prior to the study
- Individuals with additional specific dietary needs (based on the dietitian's judgment)
- Individuals with multiple food allergies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health education delivery methods | Other | Booklets, Mobile application, One to one consultation with dietitian |
Primary outcome
RECRUITMENT RATE
Time frame: Baseline visit (Day 0)
Recruitment rate of patients receiving different education delivery methods of the low FODMAP diet.
RETENTION RATE (overall and within each study group)
Time frame: Follow-up visit (week 4)
Retention rate of patients receiving different education delivery methods of the low FODMAP diet.
10 secondary outcomes
Compliance rates to the diet
Time frame: Follow-up visit (week 4)
Satisfaction over the education delivery methods received
Time frame: Baseline (Day 0) and Follow-up visit (week 4)
Appropriateness of the education methods received in each study group
Time frame: Baseline (Day 0) and Follow-up visit (week 4)
Perceived fit of the education delivery methods within the NHS
Time frame: Follow-up visit (week 4)
Willingness of participants being assigned to the study groups using a multiple choice questionnaire.
Time frame: Follow-up visit (week 4)
Gastrointestinal symptom severity
Time frame: Baseline (Day 0) and Follow-up visit (week 4)
Health-related quality of life in irritable bowel syndrome
Time frame: Baseline (Day 0) and Follow-up visit (week 4)
Gastrointestinal symptoms experienced
Time frame: Baseline and follow-up visitBaseline (Day 0) and Follow-up visit (week 4)
Adequate relief of symptoms
Time frame: Baseline (Day 0) and Follow-up visit (week 4)
Estimates of the parameters required for calculation of the sample size for a future larger study
Time frame: Screening (Week -1), Baseline (Day 0) and Follow-up visit (week 4)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miranda Lomer, PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health education delivery methods in people with Irritable Bowel Syndrome and Functional Diarrhea, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RECRUITMENT RATE (time frame: Baseline visit (Day 0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019; AzTrials last refreshed its copy on 7 Nov 2026.