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Food Limitations In Crohn's Disease and Ulcerative coliTis

NCT ID: NCT07289672

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2027-12-30

Brief Summary

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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

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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.

Conditions

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

Keywords

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IBD ulcerative colitis Crohn's disease nutritional intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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Normal diet

Group Type NO_INTERVENTION

No interventions assigned to this group

Test diet calprotectin

Group Type EXPERIMENTAL

Diet

Intervention Type OTHER

Healthy nordic based food

Test diets Nordic

Group Type EXPERIMENTAL

Diet

Intervention Type OTHER

Healthy nordic based food

Digital information tool

Group Type EXPERIMENTAL

education

Intervention Type OTHER

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

Interventions

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Diet

Healthy nordic based food

Intervention Type OTHER

education

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Skane

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mag- och tarmmottagningen, Skåne university hospital

Malmo, , Sweden

Site Status

Countries

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Sweden

Central Contacts

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Alexandra Vulcan, PhD

Role: CONTACT

Phone: +4640332388

Email: [email protected]

Facility Contacts

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Alexandra Vulcan

Role: primary

Other Identifiers

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2024-04814-01

Identifier Type: -

Identifier Source: org_study_id