Crohn Disease (CD)FLITNCT07289672
Food Limitations In Crohn's Disease and Ulcerative coliTis
A study testing Diet and education in people with Crohn Disease (CD) and Ulcerative Colitis (UC), run by Region Skane at 1 site in Sweden.
Trial summary
The goal of this clinical trial is to increase the knowledge on what type of diet affects inflammation and how to better convay that information in patients with inflammatory bowel disease (IBD) and decrease selective eating in patients with IBD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease (CD), Ulcerative Colitis (UC), IBD (Inflammatory Bowel Disease)
- What is being tested?
- Diet and education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Ulcerative colitis and Crohn's disease
- Calprotectin 200-600
Who cannot join
- Non-active disease
- solely procitis
- Severe disease
- past extensive bowel surgery
- treatment with antibiotics (last month or present)
- pregnancy
- unability to understand spoken or written Swedish
- Multimorbidity which aggrevate participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Förändrat Livsmedelsval Vid Inflammatorisk Tarmsjukdom
The goal of this clinical trial is to increase the knowledge on what type of diet affects inflammation and how to better convay that information in patients with inflammatory bowel disease (IBD) and decrease selective eating in patients with IBD. The main questions it aims to answer are:
- will the use of calprotectin as a control for changes in inflammation decrease selective food choices?
- will the use of a digital information tool increase quality of life (QoL) och decrease selctive eating patterns?
- will a diet based on nordic food choices decrease inflammation and increase QoL?
Read more
Researchers will compare with IBD-patients in ordinary care.
Participants will eat a test diet during six weeks or go through a digital information tool.
Read the detailed description
Patients with inflammatory bowel disease attending the out-patient clinic at Skåne university hospital with calprotectin 200-600 will be invited to participate in this diet intervention study. They will be divided into four arms with 35 patients in each, normal diet, test diets or diet with digital information tool.
The diet will be recorded at study start and end with a food diary for four days, as will health related quality of life. The patients clinical characteristics (demographics) and disease activity (diarrhoea frequency, blood in stools, abdominal pain, CRP and calprotectin) will be recorded.
The patients clinical characteristics (demographics) and disease activity (diarrhoea frequency, blood in stools, abdominal pain, CRP and calprotectin) will be recorded.
- Being tested
- Diet, education
- Keywords
- IBD, ulcerative colitis, Crohn's disease, nutritional intervention
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
Healthy nordic based food
educationOther
Digital information tool/education on food in inflammatory bowel disease (IBD)
| Study group | Role | What they receive |
|---|---|---|
| Normal diet | No intervention | Not described |
| Test diet calprotectin | Experimental | Not described Receives: Other: Diet |
| Test diets Nordic | Experimental | Not described Receives: Other: Diet |
| Digital information tool | Experimental | Not described Receives: Other: education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of calproteictin
Measured: From enrollment until 6 weeks
Secondary outcomes (1)
Four days registrered food intake
Food intake will be registrered at beginning and after 6 week
Measured: At beginning and after 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start1 Apr 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289672
- Sponsor's protocol ID
- 2024-04814-01
- Acronym
- FLIT
- Status last verified
- May 2026
- First submitted
- 19 Nov 2025
- Last updated
- 28 May 2026
- 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 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Förändrat Livsmedelsval Vid Inflammatorisk Tarmsjukdom
- ClinicalTrials.gov ID
- NCT07289672
- Acronym / sponsor ID
- FLIT / 2024-04814-01
- Keywords
- IBD, ulcerative colitis, Crohn's disease, nutritional intervention
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 17 Dec 2025 (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.
The goal of this clinical trial is to increase the knowledge on what type of diet affects inflammation and how to better convay that information in patients with inflammatory bowel disease (IBD) and decrease selective eating in patients with IBD. The main questions it aims to answer are:
- will the use of calprotectin as a control for changes in inflammation decrease selective food choices?
- will the use of a digital information tool increase quality of life (QoL) och decrease selctive eating patterns?
- will a diet based on nordic food choices decrease inflammation and increase QoL?
Researchers will compare with IBD-patients in ordinary care.
Participants will eat a test diet during six weeks or go through a digital information tool.
Detailed description
Patients with inflammatory bowel disease attending the out-patient clinic at Skåne university hospital with calprotectin 200-600 will be invited to participate in this diet intervention study. They will be divided into four arms with 35 patients in each, normal diet, test diets or diet with digital information tool.
The diet will be recorded at study start and end with a food diary for four days, as will health related quality of life. The patients clinical characteristics (demographics) and disease activity (diarrhoea frequency, blood in stools, abdominal pain, CRP and calprotectin) will be recorded.
The patients clinical characteristics (demographics) and disease activity (diarrhoea frequency, blood in stools, abdominal pain, CRP and calprotectin) will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal diet | No intervention | – |
| Test diet calprotectin | Experimental | Other: Diet |
| Test diets Nordic | Experimental | Other: Diet |
| Digital information tool | Experimental | Other: education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ulcerative colitis and Crohn's disease
- Calprotectin 200-600
Key exclusion criteria (8 listed)
- Non-active disease
- solely procitis
- Severe disease
- past extensive bowel surgery
- treatment with antibiotics (last month or present)
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 |
|---|---|---|
| DietHealthy nordic based food | Other | Test diet calprotectin, Test diets Nordic |
| educationDigital information tool/education on food in inflammatory bowel disease (IBD) | Other | Digital information tool |
Primary outcome
Concentration of calproteictin
Time frame: From enrollment until 6 weeks
1 secondary outcome
Four days registrered food intake
Time frame: At beginning and after 6 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- 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.
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 Diet and education in people with Crohn Disease (CD) and Ulcerative Colitis (UC), run by Region Skane at 1 site in Sweden.
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 2 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 28 May 2026. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
Concentration of calproteictin (time frame: From enrollment until 6 weeks). 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 28 May 2026.