Mb CrohnUNITANCT07389161
Uneven Nutrition and Life Style as IBD Triggers in Adolescents and Adults
A study testing Nordiet in people with Mb Crohn and Ulcerative Colitis (UC), run by Region Skane at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Mb Crohn, Ulcerative Colitis (UC)
- What is being tested?
- Nordiet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSweden
- Study dates
- 28 Apr 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- IBD, i.e., Mb Crohn or ulcerrative colitis
- Moderatively active disease (calprotectin 200-600)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Skåne University Hospital
Malmö, 21428
Klas Sjöberg, Adj professor, 40336161 ext. +46, klas.sjoberg@med.lu.se
Vedrana Vejzovic, Associate professor, 40-665 74 46 ext. +46, vedrana.vejzovic@mau.se
About this study
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.
Read the 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.
- Conditions
- Mb Crohn, Ulcerative Colitis (UC)
- Being tested
- Nordiet
- Keywords
- Diet, Inflammatory bowel disease, Mb Crohn, Ulcerative colitis
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NordietDietary supplement
Intervention with a Mediterranean like diet, the so called "Nordiet" during four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention where every one serves as their own control Receives: Dietary Supplement: Nordiet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Four weeks
Secondary outcomes (3)
Disease activity
Laboratory data:
Calprotectin (mg/kg); lower level is better.
Measured: Four weeks
Disease activity
Questionnaires:
Harvey-Bradshaw Index (ulcerative colitis). Lower levels are in accordance with lower disease activity.
Measured: Four weeks
Disease activity
Questionnaires:
CDAI (Crohn's Disease Activity Index). Lower levels are in accordance with lower disease activity.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start28 Apr 2026
- Primary completionJun 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mb CrohnStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Sequential Assignment Prospective non-randomized intevention study where everyone serves as their own control
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Malmö University, Lund University, Linkoeping University
- Responsible party
- Sponsor
- Investigators
- Vedrana Vejzovic, Associate professor, Study director, Malmö University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389161
- Sponsor's protocol ID
- 2025-01188-01 UNITA
- Other IDs
- 2025
- Acronym
- UNITA
- Status last verified
- Apr 2026
- First submitted
- 16 Dec 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data on group level can be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uneven Nutrition and Life Style as IBD Triggers in Adolescents and Adults
- ClinicalTrials.gov ID
- NCT07389161
- Acronym / sponsor ID
- UNITA / 2025-01188-01 UNITA
- Conditions
- Mb Crohn, Ulcerative Colitis (UC)
- Keywords
- Diet, Inflammatory bowel disease, Mb Crohn, Ulcerative colitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Malmö University, Lund University, Linkoeping University
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sequential Assignment Prospective non-randomized intevention study where everyone serves as their own control
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: NordietIntervention where every one serves as their own control |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- IBD, i.e., Mb Crohn or ulcerrative colitis
- Moderatively active disease (calprotectin 200-600)
Key exclusion criteria (8 listed)
- Proctitis alone
- Inactive disease
- Severe flare up requiring in-patient care
- Planned change of treatment
- Antibiotic treatment during the last month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NordietIntervention with a Mediterranean like diet, the so called "Nordiet" during four weeks. | Dietary supplement | Intervention group |
Primary outcome
Microbial composition
Time frame: Four weeks
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.
3 secondary outcomes
Disease activity
Time frame: Four weeks
Disease activity
Time frame: Four weeks
Disease activity
Time frame: Four weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Yes. Data on group level can be shared upon request.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vedrana Vejzovic, Associate professor study director
Malmö University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nordiet in people with Mb Crohn and Ulcerative Colitis (UC), run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Klas Sjöberg, Adj professor (+46 40 33 61 61 ext. +46, klas.sjoberg@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial composition (time frame: Four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.