NCT03694223

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2016

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 3, 2018

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2018

Completed
Last Updated

February 26, 2019

Status Verified

July 1, 2018

Enrollment Period

2.8 years

First QC Date

July 23, 2018

Last Update Submit

February 25, 2019

Conditions

Irritable Bowel SyndromeFunctional DiarrheaFunctional Bowel Disorder

Keywords

FODMAPDIETBLOATING

Outcome Measures

Primary Outcomes (2)

  • RECRUITMENT RATE

    Recruitment rate of patients receiving different education delivery methods of the low FODMAP diet.

    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.

    Follow-up visit (week 4)

Secondary Outcomes (10)

  • Compliance rates to the diet

    Follow-up visit (week 4)

  • Satisfaction over the education delivery methods received

    Baseline (Day 0) and Follow-up visit (week 4)

  • Appropriateness of the education methods received in each study group

    Baseline (Day 0) and Follow-up visit (week 4)

  • Perceived fit of the education delivery methods within the NHS

    Follow-up visit (week 4)

  • Willingness of participants being assigned to the study groups using a multiple choice questionnaire.

    Follow-up visit (week 4)

  • +5 more secondary outcomes

Study Arms (3)

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.

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.

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.

Other: Health education delivery methods

Interventions

Health education delivery methodsOTHER
BookletsMobile applicationOne to one consultation with dietitian

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College London

London, se1 9nh, United Kingdom

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Miranda Lomer, PhD

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2018

First Posted

October 3, 2018

Study Start

January 3, 2016

Primary Completion

October 25, 2018

Study Completion

October 25, 2018

Last Updated

February 26, 2019

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)