Food Limitations In Crohn's Disease and Ulcerative coliTis

NCT07289672 | Not Yet Recruiting

• 1 other identifier: 2024-04814-01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Crohn Disease (CD); Ulcerative Colitis (UC); IBD (Inflammatory Bowel Disease)

Keywords

IBD; ulcerative colitis; Crohn's disease; nutritional intervention

Outcome Measures

Primary Outcomes (1)

• Concentration of calproteictin

  From enrollment until 6 weeks

Secondary Outcomes (1)

• Four days registrered food intake

  At beginning and after 6 week

Study Arms (4)

Normal diet

NO INTERVENTION

Test diet calprotectin

EXPERIMENTAL

Other: Diet

Test diets Nordic

EXPERIMENTAL

Other: Diet

Digital information tool

EXPERIMENTAL

Other: education

Interventions

Diet OTHER

Healthy nordic based food

Test diet calprotectin; Test diets Nordic

education OTHER

Digital information tool/education on food in inflammatory bowel disease (IBD)

Digital information tool

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Mag- och tarmmottagningen, Skåne university hospital

Malmo, 20502, Sweden

Location

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

Diet; Educational Status

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Socioeconomic Factors; Population Characteristics

Central Study Contacts

Alexandra Vulcan, PhD

CONTACT

+4640332388; alexandra.vulcan@skane.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Although the patients know that they will be given dietary advice they will not know what type of intervention the other group will be offered. Since dietary advice must be given by the investigators the study cannot be blinded to them.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 17, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)