Food Limitations In Crohn's Disease and Ulcerative coliTis (FLIT)

May 27, 2026 updated by: Region Skane

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?

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Malmö, Sweden, 20502
        • Mag- och tarmmottagningen, Skåne university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Ulcerative colitis and Crohn's disease
  • Calprotectin 200-600

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Normal diet
Experimental: Test diet calprotectin
Other: Diet
Healthy nordic based food
Experimental: Test diets Nordic
Other: Diet
Healthy nordic based food
Experimental: Digital information tool
Other: education
Digital information tool/education on food in inflammatory bowel disease (IBD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Concentration of calproteictin
Time Frame: From enrollment until 6 weeks
From enrollment until 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Four days registrered food intake
Time Frame: At beginning and after 6 week
Food intake will be registrered at beginning and after 6 week
At beginning and after 6 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2026

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

December 4, 2025

First Posted (Actual)

December 17, 2025

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-04814-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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