Crohn DiseaseNCT04046913
The ADDapt Diet in Reducing Crohn's Disease Inflammation
A study testing Dietary education in people with Crohn Disease and Inflammatory Bowel Diseases, run by King's College London at 1 site in United Kingdom.
Trial summary
Crohn's disease (CD) results in chronic intestinal inflammation, is of increasing incidence both in the developed and developing world and has a marked impact on patient quality of life. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Crohn Disease, Inflammatory Bowel Diseases
- What is being tested?
- Dietary education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Sep 2019to 20 Aug 2024
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults aged ≥16 years
- CD diagnosis (defined by standard clinical, histological and radiological criteria) of at least 3 months
- Mildly active disease as defined by:
- Defined by physician assessment that no change in medication is required
- Faecal calprotectin >150 µg/g OR endoscopic evidence of active luminal disease OR radiological evidence of active luminal disease (by magnetic resonance enterography, or ultrasound) within the last 8 weeks.
- CDAI between 150-250
- Current body weight of ≥50 kg
- Individuals able to give informed consent and willingness to participate
Who cannot join
- Changes in dose to azathioprine, 6-mercaptopurine, methotrexate or anti-TNF-α agents or other biologics during the preceding 8 weeks, oral 5-ASA during the preceding four weeks. Currently receiving oral prednisolone/budesonide or discontinued within the last 4 weeks, unless they are on a stable dose of 10 mg/day or less prednisolone (3 mg or less budesonide) for at least 4 weeks with the intention to continue this long term.
- Used rectal 5-ASA or rectal steroids in the preceding 4 weeks
- Previous extensive bowel resection, defined as having had >2 intestinal resections, a sub-total colectomy or documented short bowel syndrome
- Poorly controlled bile acid malabsorption
- Current stoma
- Recent use of the following treatments: antibiotics, probiotics, prebiotic or fibre supplements in the preceding four weeks, NSAIDs during the preceding week
Show all 15Show fewer
- Full bowel preparation for a diagnostic procedure in preceding 4 weeks
- Comorbidities including sepsis/fever, diabetes or coeliac disease, or other concomitant serious comorbidity e.g. significant psychiatric, hepatic, renal, endocrine, respiratory, neurological or cardiovascular disease
- Exclusive enteral nutrition in the past 8 weeks
- Assessed as at nutritional risk, as defined by any of the following:
- BMI ≤18.5 kg/m2
- Previous or current eating disorder
- Currently receiving prescribed oral nutritional supplements
- Following a restrictive diet (e.g. multiple restrictions due to numerous self-reported allergies) as judged by the dietitian
- Reported pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Crohn's disease (CD) results in chronic intestinal inflammation, is of increasing incidence both in the developed and developing world and has a marked impact on patient quality of life. The prevalence of CD is 10.6 per 100,000 people in the UK and represents a significant annual financial burden of around €16.7 billion in Europe.
A wide range of nutrients and food components have been investigated for their role in the pathogenesis and course of CD. A common theme suggests that CD risk is associated with a "Western diet", including high fat, high sugar and processed foods. However, intervention studies that exclude specific aspects of the diet such as sugar or that compare low and high fat diets have failed to show effectiveness in practice. Observational human and experimental animal studies suggest that certain food additives used extensively by the food industry play a role in the pathogenesis and natural history of CD. However, to date no evidence exists for the effectiveness of a diet low in these food additives in CD.
Therefore, the aim of this study is to investigate the effects of a diet low in certain food additives compared to a normal UK diet on CD activity, health-related quality of life, gut bacteria, gut permeability, gut inflammation and dietary intake, in patients with mildly active, stable CD. We will recruit patients with mildly active CD and will randomise them to receive either the diet low in the food additives of interest, or the diet representative of a normal UK diet. Patients will follow their allocation diet for 8 weeks and will attend study visits at the start and end of the trial, at which points questionnaires will be completed and samples will be collected.
- Conditions
- Crohn Disease, Inflammatory Bowel Diseases
- Being tested
- Dietary education
- Keywords
- Dietary intervention
- 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.
Dietary educationBehavioural
Intervention: Low food additive diet. Control: Habitual food additive diet
| Study group | Role | What they receive |
|---|---|---|
| Low food additive diet | Active comparator | Dietary advice, given by a dietitian, will be discussed at trial baseline. Receives: Behavioral: Dietary education |
| Habitual food additive diet | Placebo comparator | Dietary advice, given by a dietitian, will be discussed at trial baseline. Receives: Behavioral: Dietary education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crohn's Disease Activity Index
The proportion of patients achieving at least a 70-point reduction in the Crohn's Disease Activity Index from baseline to week 8
Measured: Difference between baseline and week 8
Secondary outcomes (22)
Faecal calprotectin
The proportion of patients achieving at least a 50% reduction in faecal calprotectin concentration.
Measured: Baseline, 8 weeks and 26 weeks
Faecal calprotectin
Absolute and change in faecal calprotectin concentrations during the trial.
Measured: Baseline, 8 weeks and 26 weeks
Faecal calprotectin
Proportion of patients achieving faecal calprotectin concentrations <150 µg/g.
Measured: Baseline, 8 weeks and 26 weeks
Serum C-reactive protein
Absolute and change in CRP concentration and proportion of patients achieving a CRP concentration <5 mg/L
Measured: Baseline, 8 weeks and 26 weeks
Mucosal immune cell gene expression
RNA sequencing on GI immune cells isolated from rectal biopsies
Measured: Baseline and 8 weeks
Crohn's Disease Activity Index (CDAI)
Absolute and change in CDAI score during the trial.
Measured: Baseline, 8 weeks and 26 weeks
Crohn's Disease Activity Index (CDAI)
Proportion of patients achieving a CDAI score <150 points (clinical remission) by 8 weeks.
Measured: Baseline and 8 weeks
Crohn's Disease Activity Index (CDAI)
Proportion of patients achieving ≥100-point reduction in CDAI score by 8 weeks.
Measured: Baseline and 8 weeks
Stool Output
Absolute and change in stool frequency and consistency
Measured: Baseline, 8 weeks and 26 weeks
Perceived Crohn's disease control
Absolute and change in score in IBD-control questionnaire
Measured: Baseline, 8 weeks and 26 weeks
Health related quality of life
Absolute and change in Inflammatory Bowel Disease questionnaire (IBDQ) score, and proportion of patients achieving clinical remission i.e., IBDQ score >168
Measured: Baseline, 8 weeks and 26 weeks
Faecal microbiota composition
Shotgun sequencing
Measured: Baseline, 8 weeks and 26 weeks
Faecal microbial gene expression
Meta-transcriptomics
Measured: Baseline, 8 weeks and 26 weeks (in a subset of participants)
Mucosal microbiota composition
16S sequencing
Measured: Baseline and 8 weeks (in a subset of participants)
Gastrointestinal permeability
Sugar probe solution urinary analysis to determine intestinal permeability
Measured: Baseline and 8 weeks
Dietary intake
Micronutrient and macronutrient intake, food intake and dietary pattern
Measured: Baseline, 8 weeks and 26 weeks
Dietary adherence
Reduction in intake of food additives and consumption of study foods and snacks
Measured: Baseline, 8 weeks and 26 weeks
Diet feasibility and acceptability
Acceptability questionnaire, including food-related quality of life
Measured: Baseline, 8 weeks and 26 weeks
Physical Activity
International Physical Activity Questionnaire
Measured: Baseline, 8 weeks and 26 weeks
Metabolomics
Metabolomics analyses through Liquid Chromatography - Mass Spectrometry using validated assays.
Measured: Baseline and 8 weeks
Biomarker study
Biomarker study through Nuclear Magnetic Resonance Spectroscopy
Measured: Baseline and 8 weeks
Genetics
Whole genome single nucleotide polymorphism array genotyping
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start9 Sep 2019
- Primary completion25 Apr 2024
- Study completion20 Aug 2024 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust, Guy's and St Thomas' NHS Foundation Trust, Institut Pasteur
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046913
- Sponsor's protocol ID
- IRAS 260196
- Status last verified
- Jan 2024
- First submitted
- 26 Jul 2019
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ADDapt Diet in Reducing Crohn's Disease Inflammation
- ClinicalTrials.gov ID
- NCT04046913
- Acronym / sponsor ID
- IRAS 260196
- Conditions
- Crohn Disease, Inflammatory Bowel Diseases
- Keywords
- Dietary intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust, Guy's and St Thomas' NHS Foundation Trust, Institut Pasteur
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 20 Aug 2024 (estimated)
- First posted
- 6 Aug 2019 (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.
Crohn's disease (CD) results in chronic intestinal inflammation, is of increasing incidence both in the developed and developing world and has a marked impact on patient quality of life. The prevalence of CD is 10.6 per 100,000 people in the UK and represents a significant annual financial burden of around €16.7 billion in Europe.
A wide range of nutrients and food components have been investigated for their role in the pathogenesis and course of CD. A common theme suggests that CD risk is associated with a "Western diet", including high fat, high sugar and processed foods. However, intervention studies that exclude specific aspects of the diet such as sugar or that compare low and high fat diets have failed to show effectiveness in practice. Observational human and experimental animal studies suggest that certain food additives used extensively by the food industry play a role in the pathogenesis and natural history of CD. However, to date no evidence exists for the effectiveness of a diet low in these food additives in CD.
Therefore, the aim of this study is to investigate the effects of a diet low in certain food additives compared to a normal UK diet on CD activity, health-related quality of life, gut bacteria, gut permeability, gut inflammation and dietary intake, in patients with mildly active, stable CD. We will recruit patients with mildly active CD and will randomise them to receive either the diet low in the food additives of interest, or the diet representative of a normal UK diet. Patients will follow their allocation diet for 8 weeks and will attend study visits at the start and end of the trial, at which points questionnaires will be completed and samples will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low food additive diet | Active comparator | Behavioral: Dietary educationDietary advice, given by a dietitian, will be discussed at trial baseline. |
| Habitual food additive diet | Placebo comparator | Behavioral: Dietary educationDietary advice, given by a dietitian, will be discussed at trial baseline. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged ≥16 years
- CD diagnosis (defined by standard clinical, histological and radiological criteria) of at least 3 months
- Mildly active disease as defined by:
- Current body weight of ≥50 kg
- Individuals able to give informed consent and willingness to participate
Key exclusion criteria (15 listed)
- Changes in dose to azathioprine, 6-mercaptopurine, methotrexate or anti-TNF-α agents or other biologics during the preceding 8 weeks, oral 5-ASA during the preceding four weeks. Currently receiving oral prednisolone/budesonide or discontinued within the last 4 weeks, unless they are on a stable dose of 10 mg/day or less prednisolone (3 mg or less budesonide) for at least 4 weeks with the intention to continue this long term.
- Used rectal 5-ASA or rectal steroids in the preceding 4 weeks
- Previous extensive bowel resection, defined as having had >2 intestinal resections, a sub-total colectomy or documented short bowel syndrome
- Poorly controlled bile acid malabsorption
- Current stoma
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 |
|---|---|---|
| Dietary educationIntervention: Low food additive diet. Control: Habitual food additive diet | Behavioural | Habitual food additive diet, Low food additive diet |
Primary outcome
Crohn's Disease Activity Index
Time frame: Difference between baseline and week 8
The proportion of patients achieving at least a 70-point reduction in the Crohn's Disease Activity Index from baseline to week 8
22 secondary outcomes
Faecal calprotectin
Time frame: Baseline, 8 weeks and 26 weeks
Faecal calprotectin
Time frame: Baseline, 8 weeks and 26 weeks
Faecal calprotectin
Time frame: Baseline, 8 weeks and 26 weeks
Serum C-reactive protein
Time frame: Baseline, 8 weeks and 26 weeks
Mucosal immune cell gene expression
Time frame: Baseline and 8 weeks
Crohn's Disease Activity Index (CDAI)
Time frame: Baseline, 8 weeks and 26 weeks
Crohn's Disease Activity Index (CDAI)
Time frame: Baseline and 8 weeks
Crohn's Disease Activity Index (CDAI)
Time frame: Baseline and 8 weeks
Stool Output
Time frame: Baseline, 8 weeks and 26 weeks
Perceived Crohn's disease control
Time frame: Baseline, 8 weeks and 26 weeks
Health related quality of life
Time frame: Baseline, 8 weeks and 26 weeks
Faecal microbiota composition
Time frame: Baseline, 8 weeks and 26 weeks
Faecal microbial gene expression
Time frame: Baseline, 8 weeks and 26 weeks (in a subset of participants)
Mucosal microbiota composition
Time frame: Baseline and 8 weeks (in a subset of participants)
Gastrointestinal permeability
Time frame: Baseline and 8 weeks
Dietary intake
Time frame: Baseline, 8 weeks and 26 weeks
Dietary adherence
Time frame: Baseline, 8 weeks and 26 weeks
Diet feasibility and acceptability
Time frame: Baseline, 8 weeks and 26 weeks
Physical Activity
Time frame: Baseline, 8 weeks and 26 weeks
Metabolomics
Time frame: Baseline and 8 weeks
Biomarker study
Time frame: Baseline and 8 weeks
Genetics
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Crohn Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary education 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 8 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 6 Jun 2024. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Crohn's Disease Activity Index (time frame: Difference between baseline and week 8). 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 6 Jun 2024.