Uneven Nutrition and Life Style as IBD Triggers in Adolescents and Adults (UNITA)

Region Skane

Status: Not yet enrolling

Conditions: Mb Crohn; Ulcerative Colitis (UC)

Treatments: Dietary Supplement: Nordiet

Study type: Interventional

Funder types: Other

Identifiers

NCT07389161

2025-01188-01 UNITA

Details and patient eligibility

About

The aims of the study are 1. to determine the effect on dysbiosis, permeability and inflammatory activity after administration of a Mediterranean like diet (a Nordic equivalent, "Nordiet"), 2. to investigate life style related factors, such as exercise, psychosexual health and quality of life and their relation to the disease activity.

Full description

The project aims, firstly, to map the quality of life and psychosexual health of young IBD patients (18-35 years), secondly, to investigate what treatment effect a changed diet can bring, and thirdly, to investigate whether physical activity and body composition can be related to disease activity.

The investigators want to use a natural food based on Mediterranean diet without artificial additives to evaluate the effect on the degree of disease activity through analysis of customary clinical parameters such as symptom picture and lab work including calprotectin (in stool samples) but mainly analysis of the gut microbiota and bacterial DNA in the blood as a marker for intestinal health.

Physical activity can be a possible treatment. By combining activity bracelets with analysis of autonomic balance (heart rate variability) and sleep quality, examinations of symptom burden and inflammatory activity, new valuable knowledge can be obtained.

Associations have been demonstrated between active IBD, depression, stress, fatigue, quality of life and sexual function in both women and men. It is therefore important to investigate psychosexual health and quality of life among young people with IBD and to also evaluate the effects of intervention through questionnaires and qualitative interviews.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• IBD, i.e., Mb Crohn or ulcerrative colitis
• Moderatively active disease (calprotectin 200-600)

Exclusion criteria

• Proctitis alone
• Inactive disease
• Severe flare up requiring in-patient care
• Planned change of treatment
• Antibiotic treatment during the last month
• Pregnancy
• Inability to understand Swedish
• Multimorbidity

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 1 patient group

Intervention group

Experimental group

Description:

Intervention where every one serves as their own control

Treatment:

Dietary Supplement: Nordiet