This study will evaluate if the Groningen Anti-Inflammatory Diet and the ileocolonic delivery of vitamin B2, B3 and C can positively influence the course of Crohn's disease and can positively alter the gut microbiome of Crohn's disease patients as well as healthy volunteers.
It is becoming increasingly more well known that diet and the microbiome have a pivotal role in the development and course of inflammatory bowel diseases (IBD). Strict exclusive enteral nutrition (EEN) can induce remission in Crohn's Disease (CD) and is the standard treatment in paediatric CD. Implementing a restrictive diet in adults is difficult; adult patients do not tend to adhere to EEN. Recently, the CD-exclusion diet (CDED) combined with partial enteral nutrition demonstrated to be effective in CD-patients with flares. Additionally, accumulating evidence suggests that intake of vitamins can influence disease course, mainly by beneficially modulating the gut microbiota and gut redox potential, especially if the vitamins can be delivered to the colon. Nevertheless, no dietary guidelines are available to physicians and patients. Due to complaints of certain foods and patients' eagerness to postpone new flares, patients start experimenting with their food. As patients with CD are already often malnourished, this poorly substantiated experimenting puts them even more at risk for malnutrition and could have a potential negative effect on their disease outcomes. Next, quality of life of patients decreases and healthcare costs will rise. Therefore, both patients and physicians are in desperate need of evidence for an anti-inflammatory dietary advice in CD. As compliance to a diet increases when they are supported by family members, their household members will also be asked to participate in the study. Simultaneously studying their healthy family members will also provide information of the effect of this anti-inflammatory diet or intake of lieocolonic-delivered vitamins on their microbiome and markers of inflammation and oxidative stress.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
510
Specially designed diet based on the most recent scientific evidence of the inflammatory characteristics of food and food groups. Basically, subjects will be instructed to increase uptake of food components that hold potential anti-inflammatory proportions and to avoid food components that may showcase potential pro-inflammatory proportions.
Vitamin B2/B3/C supplement in a ColoPulse-coated capsule
A capsule containing microcrystalline cellulose which is coated using the same ColoPulse technology as is used with the ColoVit
University Medical Center Groningen
Groningen, Netherlands
RECRUITINGChange in faecal calprotectin
Primary outcome for CD patients
Time frame: Faeces sample collection at 4 time points: At baseline (0 months), after 3 months, after 6 months, after 12 months
Change in microbiome composition measured by metagenomic sequencing- based profiles
Primary outcome for healthy volunteers and CD patients
Time frame: Faeces sample collection at 3 time points: At baseline (0 months), after 3 months, after 12 months
The number of flares (defined as faecal calprotectin >200 μg/g and Crohn's Disease Activity Index (CDAI) ≥220 points)
Secondary outcome for CD patients
Time frame: Faeces sample collection and CDAI score determination at 4 time points: At baseline (0 months), after 3 months, after 6 months, after 12 months
Improvements of Quality of life scores as assessed by Inflammatory Bowel Disease Questionnaire (Score range of 32-224, The higher the score the higher the Quality of Life)
Secondary outcome for CD patients
Time frame: Questionnaires at 3 time points: At baseline (0 months), after 3 months, after 12 months
Improvements of Quality of life scores as assessed Food Related Quality of Life Questionnaire (Score range of 29-145, The higher the score the higher the Food related-Quality of Life)
Secondary outcome for CD patients and healthy volunteers
Time frame: Questionnaires at 3 time points: At baseline (0 months), after 3 months, after 12 months
Adherence to the dietary interventions as assessed by a Dietary Compliance Questionnaire
Secondary outcome for CD patients and healthy volunteers
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Time frame: Questionnaires at 3 time points: At baseline (0 months), after 3 months, after 12 months