How uneven diet and lifestyle may trigger IBD in adolescents and adults
Uneven Nutrition and Life Style as IBD Triggers in Adolescents and Adults
See if switching to a Mediterranean-style 'Nordiet' helps young adults with moderately active Crohn's disease or ulcerative colitis reduce gut inflammation and feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | All |
| Sponsor | Region Skane Academic / other |
| Locations | 1 site (Malmö) |
| Trial ID | NCT07389161 on ClinicalTrials.gov |
What this trial studies
This project maps quality of life and psychosexual health in young people with IBD (ages 18–35) and tests the effect of a Mediterranean-like 'Nordiet' on gut health and disease activity. The diet intervention uses natural, additive-free foods and outcomes include symptom scores, stool calprotectin, gut microbiota composition, and bacterial DNA in blood as markers of intestinal health. Physical activity, sleep, and autonomic balance are tracked using activity bracelets and heart rate variability to explore links between exercise, body composition, and disease activity. Psychosexual health and quality of life will also be measured by questionnaires and qualitative interviews to capture patient-reported outcomes.
Who should consider this trial
Good fit: Ideal candidates are Swedish-speaking adults about 18–35 years old with moderately active Crohn's disease or ulcerative colitis (stool calprotectin 200–600), not pregnant, without recent antibiotic use, planned treatment changes, or major comorbidities.
Not a fit: Patients with inactive disease, proctitis alone, severe flares requiring hospitalization, recent antibiotic treatment, pregnancy, multimorbidity, or inability to understand Swedish are unlikely to benefit or to be eligible.
Why it matters
Potential benefit: If successful, the Nordiet and lifestyle measures could lower intestinal inflammation, improve microbiome balance, and enhance symptoms and quality of life for young adults with moderately active IBD.
How similar studies have performed: Observational studies and some small trials have suggested Mediterranean-style diets can improve the gut microbiome and symptoms in IBD, but larger randomized evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Malmö
- Skåne University Hospital — Malmö, Sweden (Recruiting)
Study contacts
- Study coordinator: Klas Sjöberg, Adj professor
- Email: klas.sjoberg@med.lu.se
- Phone: +46 40 33 61 61
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.