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

Region Skane

Status: Not yet enrolling

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

Treatments: Other: education; Other: Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT07289672

2024-04814-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 4 patient groups

Normal diet

No Intervention group

Test diet calprotectin

Experimental group

Treatment:

Other: Diet

Test diets Nordic

Experimental group

Treatment:

Other: Diet

Digital information tool

Experimental group

Treatment:

Other: education