Crohn DiseaseNCT03691155
The Feasibility of Following the Crohn's Diet
A study testing The Crohn's Diet in people with Crohn Disease and Inflammatory Bowel Diseases, run by King's College London at 1 site in United Kingdom.
Trial summary
A research team from King's College London are investigating how diet can be used as a treatment for Crohn's disease. The investigators have designed a new diet and eventually wish to test whether the diet can be used to manage Crohn's disease and reduce gut inflammation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease, Inflammatory Bowel Diseases, Dietary Modification
- What is being tested?
- The Crohn's Diet
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Jul 2018to 18 Dec 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
- Adults aged ≥18 years with a diagnosis of Crohn's disease
- Stable Crohn's disease (as defined as self-reported: no change in Crohn's disease medication in the last 3 months; no Crohn's disease surgery in the last 6 months; no hospital admissions related to Crohn's disease in the last 6 months; no new perianal Crohn's disease in the last 6 months).
- Individuals with a Body Mass Index (BMI) of ≥ 18.5 kg/m2
- Individuals able to give informed consent
- Individuals able to understand and read English
- Individuals willing to provide consent in this study which involves a dietary change for 14 days
Who cannot join
- Unexplained/unintentional weight loss in the past 6 months
- Major co-morbidities; for example, diabetes, coeliac disease, major active psychiatric conditions or current eating disorders.
- Current Crohn's disease therapy with any of the following: corticosteroids, exclusive or partial enteral nutrition (liquid nutrition), and any participants prescribed oral nutrition supplements for nutrition support.
- Individuals who report to be pregnant or lactating
- Individuals with specific, complex dietary needs (based on the dietitian's judgment), such as multiple food allergies, in which the additional burden of the Crohn's Diet would pose a nutrition risk.
Trial locations and contacts
1 site in 1 country.
About this study
A research team from King's College London are investigating how diet can be used as a treatment for Crohn's disease. The investigators have designed a new diet and eventually wish to test whether the diet can be used to manage Crohn's disease and reduce gut inflammation. Before doing this, the investigators need to find out how practical it is for people to follow the diet for 14 days by conducting this 'feasibility' study. A feasibility study is a small study that aims to highlight any issues before informing the design of a larger research trial.
The diet the investigators have designed is called the Crohn's Diet. The evidence for this diet is based on recent research which suggests that certain food ingredients may be involved in triggering gut inflammation.
The study's primary aim is to assess the practicalities of following the Crohn's Diet. It will also assess compliance to the Crohn's Diet and if following it changes the nutritional balance from the normal diet.
- Being tested
- The Crohn's Diet
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Crohn's DietOther
All recruited participants will be educated on the Crohn's Diet and instructed to adhere to the study diet for 14 days.
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of following the Crohn's Diet: questionnaire
Method: Collation of participant feedback during the Crohn's Diet and administer diet feasibility questionnaire. This questionnaire uses an adapted Education Method Usability Scale (Bangor et al. 2008) ('strongly agree' to 'strongly disagree' style scale) and open questions.
Measured: Throughout the 14-day intervention
Secondary outcomes (6)
Acceptability of following the Crohn's Diet: questionnaire
Method: Administer questionnaires on diet acceptability, including the Food-Related Quality of Life in Inflammatory Bowel Disease questionnaire (Hughes et al 2016).
Measured: Throughout the 14-day intervention and within one week of completing the intervention
Participant compliance to the Crohn's Diet
Method: Dietitian monitoring of compliance during the trial. A 7-day food diary will quantify compliance alongside a questionnaire which explores reasons for potential non-compliance.
Measured: Throughout the 14-day intervention
Impact of the Crohn's Diet on habitual dietary intake
Method: 7-day food diaries to compare nutrient intake and explore changes in dietary patterns.
Measured: One week before the intervention and throughout the 14-day intervention
Impact of the Crohn's Diet on BMI
Method: Participants will undergo anthropometric assessment, including weight and height to report BMI.
Measured: One week before the intervention and within one week of completing the 14-day intervention
Impact of the Crohn's Diet on gastrointestinal symptoms
Method: Administer the PRO-2 questionnaire (Khanna et al 2015).
Measured: One week before the intervention and within one week of completing the 14-day intervention
Impact of the Crohn's Diet on perceived disease control
Method: Administer questionnaires, including the Inflammatory Bowel Disease Control-8 questionnaire (IBD-C-8) (Bodger et al. 2013).
Measured: One week before the intervention and within one week of completing the 14-day intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start8 Jul 2018
- Primary completion18 Dec 2018
- Study completion18 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Whelan, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691155
- Sponsor's protocol ID
- LRS-17/18-7313
- Status last verified
- Feb 2019
- First submitted
- 20 Sep 2018
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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
- The Feasibility of Following the Crohn's Diet
- ClinicalTrials.gov ID
- NCT03691155
- Acronym / sponsor ID
- LRS-17/18-7313
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 8 Jul 2018 (actual)
- Primary completion
- 18 Dec 2018 (actual)
- Study completion
- 18 Dec 2018 (actual)
- First posted
- 1 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.
A research team from King's College London are investigating how diet can be used as a treatment for Crohn's disease. The investigators have designed a new diet and eventually wish to test whether the diet can be used to manage Crohn's disease and reduce gut inflammation. Before doing this, the investigators need to find out how practical it is for people to follow the diet for 14 days by conducting this 'feasibility' study. A feasibility study is a small study that aims to highlight any issues before informing the design of a larger research trial.
The diet the investigators have designed is called the Crohn's Diet. The evidence for this diet is based on recent research which suggests that certain food ingredients may be involved in triggering gut inflammation.
The study's primary aim is to assess the practicalities of following the Crohn's Diet. It will also assess compliance to the Crohn's Diet and if following it changes the nutritional balance from the normal diet.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged ≥18 years with a diagnosis of Crohn's disease
- Stable Crohn's disease (as defined as self-reported: no change in Crohn's disease medication in the last 3 months; no Crohn's disease surgery in the last 6 months; no hospital admissions related to Crohn's disease in the last 6 months; no new perianal Crohn's disease in the last 6 months).
- Individuals with a Body Mass Index (BMI) of ≥ 18.5 kg/m2
- Individuals able to give informed consent
- Individuals able to understand and read English
Key exclusion criteria (5 listed)
- Unexplained/unintentional weight loss in the past 6 months
- Major co-morbidities; for example, diabetes, coeliac disease, major active psychiatric conditions or current eating disorders.
- Current Crohn's disease therapy with any of the following: corticosteroids, exclusive or partial enteral nutrition (liquid nutrition), and any participants prescribed oral nutrition supplements for nutrition support.
- Individuals who report to be pregnant or lactating
- Individuals with specific, complex dietary needs (based on the dietitian's judgment), such as multiple food allergies, in which the additional burden of the Crohn's Diet would pose a nutrition risk.
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 |
|---|---|---|
| The Crohn's DietAll recruited participants will be educated on the Crohn's Diet and instructed to adhere to the study diet for 14 days. | Other | – |
Primary outcome
Feasibility of following the Crohn's Diet: questionnaire
Time frame: Throughout the 14-day intervention
Method: Collation of participant feedback during the Crohn's Diet and administer diet feasibility questionnaire. This questionnaire uses an adapted Education Method Usability Scale (Bangor et al. 2008) ('strongly agree' to 'strongly disagree' style scale) and open questions.
6 secondary outcomes
Acceptability of following the Crohn's Diet: questionnaire
Time frame: Throughout the 14-day intervention and within one week of completing the intervention
Participant compliance to the Crohn's Diet
Time frame: Throughout the 14-day intervention
Impact of the Crohn's Diet on habitual dietary intake
Time frame: One week before the intervention and throughout the 14-day intervention
Impact of the Crohn's Diet on BMI
Time frame: One week before the intervention and within one week of completing the 14-day intervention
Impact of the Crohn's Diet on gastrointestinal symptoms
Time frame: One week before the intervention and within one week of completing the 14-day intervention
Impact of the Crohn's Diet on perceived disease control
Time frame: One week before the intervention and within one week of completing the 14-day intervention
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.
Kevin Whelan 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 The Crohn's Diet in people with Crohn Disease and Inflammatory Bowel Diseases, 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 6 inclusion and 5 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?
Feasibility of following the Crohn's Diet: questionnaire (time frame: Throughout the 14-day intervention). 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.