Uneven Nutrition and Life Style as IBD Triggers in Adolescents and Adults

NCT07389161 | Recruiting

• 1 other identifier: 2025-01188-01 UNITA
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mb Crohn; Ulcerative Colitis (UC)

Keywords

Diet; Inflammatory bowel disease; Mb Crohn; Ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Disease activity

  Four weeks

• Disease activity

  Four weeks

• Disease activity

  Four weeks

Other Outcomes (1)

• Sleep quality

  Four weeks.

Study Arms (1)

Intervention group

EXPERIMENTAL

Intervention where every one serves as their own control

Dietary Supplement: Nordiet

Interventions

Nordiet DIETARY_SUPPLEMENT

Intervention with a Mediterranean like diet, the so called "Nordiet" during four weeks.

Intervention group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Skane: lead
• Malmö University: collaborator
• Lund University: collaborator
• Linkoeping University: collaborator

Study Sites (1)

Skåne University Hospital

Malmo, 21428, Sweden

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Vedrana Vejzovic, Associate professor

  Malmö University

  STUDY DIRECTOR

Central Study Contacts

Klas Sjöberg, Adj professor

CONTACT

+46 40 33 61 61; klas.sjoberg@med.lu.se

Vedrana Vejzovic, Associate professor

CONTACT

+46 40 665 74 46; vedrana.vejzovic@mau.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sequential Assignment Prospective non-randomized intevention study where everyone serves as their own control

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: February 5, 2026
• Study Start: April 28, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 2026 Feb 01 - 2029 Dec 31
• Access Criteria: In order to establish research cooperation.

Locations

SE (1)