Uneven Nutrition and Life Style as IBD Triggers in Adolescents and Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nordiet.
- Who it may be relevant to
- Registry conditions: Mb Crohn, Ulcerative Colitis (UC). Basic parameters: 18 years — 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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.
Interventions
- Dietary supplement Nordiet
Intervention with a Mediterranean like diet, the so called "Nordiet" during four weeks.
Primary outcome measures
- Microbial composition [Time frame: Four weeks]
Secondary outcome measures (3)
- Disease activity [Time frame: Four weeks]
- Disease activity [Time frame: Four weeks]
- Disease activity [Time frame: Four weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Skåne University Hospital — Malmö
Identifiers
NCT: NCT07389161 · 2025-01188-01 UNITA