Food Limitations In Crohn's Disease and Ulcerative coliTis
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: Diet, education.
- Who it may be relevant to
- Registry conditions: Crohn Disease (CD), Ulcerative Colitis (UC), IBD (Inflammatory Bowel Disease). Basic parameters: from 18 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 →
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Official title
Förändrat Livsmedelsval Vid Inflammatorisk Tarmsjukdom
Overview
The goal of this clinical trial is to increase the knowledge on what type of diet affects inflammation and how to better convay that information in patients with inflammatory bowel disease (IBD) and decrease selective eating in patients with IBD. The main questions it aims to answer are: * will the use of calprotectin as a control for changes in inflammation decrease selective food choices? * will the use of a digital information tool increase quality of life (QoL) och decrease selctive eating patterns? * will a diet based on nordic food choices decrease inflammation and increase QoL? Researchers will compare with IBD-patients in ordinary care. Participants will eat a test diet during six weeks or go through a digital information tool.
Detailed description
Patients with inflammatory bowel disease attending the out-patient clinic at Skåne university hospital with calprotectin 200-600 will be invited to participate in this diet intervention study. They will be divided into four arms with 35 patients in each, normal diet, test diets or diet with digital information tool.
The diet will be recorded at study start and end with a food diary for four days, as will health related quality of life. The patients clinical characteristics (demographics) and disease activity (diarrhoea frequency, blood in stools, abdominal pain, CRP and calprotectin) will be recorded.
The patients clinical characteristics (demographics) and disease activity (diarrhoea frequency, blood in stools, abdominal pain, CRP and calprotectin) will be recorded.
Interventions
- Other Diet
Healthy nordic based food - Other education
Digital information tool/education on food in inflammatory bowel disease (IBD)
Primary outcome measures
- Concentration of calproteictin [Time frame: From enrollment until 6 weeks]
Secondary outcome measures (1)
- Four days registrered food intake [Time frame: At beginning and after 6 week]
Eligibility criteria
Inclusion criteria
- Ulcerative colitis and Crohn's disease
- Calprotectin 200-600
Exclusion criteria
- Non-active disease
- solely procitis
- Severe disease
- past extensive bowel surgery
- treatment with antibiotics (last month or present)
- pregnancy
- unability to understand spoken or written Swedish
- Multimorbidity which aggrevate participation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Mag- och tarmmottagningen, Skåne university hospital — Malmö
Identifiers
NCT: NCT07289672 · 2024-04814-01