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

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.

Study Overview

• Status: Recruiting
• Conditions: Ulcerative Colitis (UC); Mb Crohn
• Intervention / Treatment: Dietary supplement: Nordiet

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Klas Sjöberg, Adj professor; Phone Number: +46 +46 40 33 61 61; Email: klas.sjoberg@med.lu.se
• Study Contact Backup: Name: Vedrana Vejzovic, Associate professor; Phone Number: +46 +46 40 665 74 46; Email: vedrana.vejzovic@mau.se

Study Locations

• Sweden
  • Malmo, Sweden, 21428
    • Recruiting
    • Skåne University Hospital
    • Contact: Klas Sjöberg, Adj professor; Phone Number: +46 40336161; Email: klas.sjoberg@med.lu.se
    • Contact: Vedrana Vejzovic, Associate professor; Phone Number: +46 40-665 74 46; Email: vedrana.vejzovic@mau.se
    • Principal Investigator: Klas Sjöberg, Adj professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Intervention where every one serves as their own control	Dietary supplement: Nordiet; Intervention with a Mediterranean like diet, the so called "Nordiet" during four weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbial composition	Gut microbiota will be analyzed at start and after four weeks. The health promoting efect of the diet will be estimated with analysis of the total bacterial genome down to species level. The bacterial composition will then be analyzed with regard to presence of beneficial or harmful bacteria. Based on the complexity of the micorbiota it is not possible to state any specific value that should be achieved.	Four weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease activity	Laboratory data: Calprotectin (mg/kg); lower level is better.	Four weeks
Disease activity	Questionnaires: Harvey-Bradshaw Index (ulcerative colitis). Lower levels are in accordance with lower disease activity.	Four weeks
Disease activity	Questionnaires: CDAI (Crohn's Disease Activity Index). Lower levels are in accordance with lower disease activity.	Four weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep quality	Activity bracelets will be used for measurements of sleep quality: This is based on a value that is a combination of time for sleep onset (minutes, shorter is better), the number of awakenings (fewer is better) and the amount of REM sleep during the night (minutes, more is better). A cut-off level is not appropriate. It is indvidual and must be based both on absolute outcome and relative change.	Four weeks.

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: Lund University; Linkoeping University; Malmö University
• Investigators: Study Director: Vedrana Vejzovic, Associate professor, Malmö University

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: January 30, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Diet; Ulcerative colitis; Inflammatory bowel disease; Mb Crohn
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Colitis; Colitis, Ulcerative; Inflammatory Bowel Diseases
• Other Study ID Numbers: 2025-01188-01 UNITA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data on group level can be shared upon request.
• IPD Sharing Time Frame: 2026 Feb 01 - 2029 Dec 31
• IPD Sharing Access Criteria: In order to establish research cooperation.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No