Crohn Disease
Conditions
Keywords
Inflammatory Bowel Disease, IBD, Crohn, Vitamins, Diet, Riboflavin, Ascorbic Acid, Niacin, Microbiome
Brief summary
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.
Detailed description
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.
Interventions
OTHERGroningen Anti-Inflammatory Diet (GrAID)
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.
DIETARY_SUPPLEMENTColoVit capsule
Vitamin B2/B3/C supplement in a ColoPulse-coated capsule
OTHERColoPulse-placebo capsule
A capsule containing microcrystalline cellulose which is coated using the same ColoPulse technology as is used with the ColoVit
Sponsors
University Medical Center Groningen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized, partly blinded, multicenter clinical food trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
CD patients: * Participant understands the study procedures and signed an informed consent to participate in this study * Previously diagnosed with CD; Montreal classification: L1 (Ileal), L2 (colonic), or L3 (ileocolonic). * Low-mild disease activity (no clinically relevant symptoms and HBI\<8 or CDAI \<220) * Evidence of mucosal inflammation (faecal calprotectin ≥100 μg/g) * Able to attend to the outpatient clinic of the UMCG, Martini Hospital, MCL Leeuwarden or Isala * ≥18 years of age * Able to use oral feeding and willing to undergo a dietary intervention (Follow a diet or use a vitamin B2/B3/C supplement or placebo) Inclusion Criteria healthy volunteers: * Participant understands the study procedures and signed an informed consent to participate in this study * Never been diagnosed with IBD or any other chronic inflammatory condition. * Participant has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the investigator on the basis of medical history and routine laboratory test results. * Able to attend to the outpatient clinic of the UMCG, Martini Hospital, MCL Leeuwarden or Isala * ≥18 year of age * Able to use oral feeding and willing to undergo a dietary intervention (Follow a diet or use a vitamin B2/B3/C supplement or placebo)
Exclusion criteria
CD patients: * Life expectancy \<12 months * Active Crohn's disease (HBI≥8 or CDAI\>220), or expecting drug intervention within 3 months * Colonoscopy and colon cleansing in the past 3 months; * Use antibiotics, probiotics (eg Yakult, Vifit, Activia) or specific prebiotics supplements 3 weeks prior to the start of the intervention * Use of vitamin/mineral supplements 1 week prior to the start of the intervention (except for vitamin D and/or calcium) * Use Methotrexate drugs or chronic use of antacids, H2 or proton-pump inhibitors * With a history of GI disorders or GI surgery that are likely to interfere with the pH-dependent mode of action of the Colovit-capsule * Patients with a pouch or stoma * Pregnant or breastfeeding (or foreseen pregnancy during dietary intervention period) * Swallowing disorders, not able to tolerate oral food, or use of tube feeding (EEN) * Previously proven anaphylactic reaction to foods included in the food boxes * Previously diagnosed with Celiac Disease or following a gluten-free diet * Following a vegetarian or vegan diet
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in faecal calprotectin | Faeces sample collection at 4 time points: At baseline (0 months), after 3 months, after 6 months, after 12 months | Primary outcome for CD patients |
| Change in microbiome composition measured by metagenomic sequencing- based profiles | Faeces sample collection at 3 time points: At baseline (0 months), after 3 months, after 12 months | Primary outcome for healthy volunteers and CD patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of flares (defined as faecal calprotectin >200 μg/g and Crohn's Disease Activity Index (CDAI) ≥220 points) | Faeces sample collection and CDAI score determination at 4 time points: At baseline (0 months), after 3 months, after 6 months, after 12 months | Secondary outcome for CD patients |
| 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) | Questionnaires at 3 time points: At baseline (0 months), after 3 months, after 12 months | Secondary outcome for CD patients |
| 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) | Questionnaires at 3 time points: At baseline (0 months), after 3 months, after 12 months | Secondary outcome for CD patients and healthy volunteers |
| Adherence to the dietary interventions as assessed by a Dietary Compliance Questionnaire | Questionnaires at 3 time points: At baseline (0 months), after 3 months, after 12 months | Secondary outcome for CD patients and healthy volunteers |
Countries
Netherlands
Contacts
Primary ContactGerard Dijkstra, MD PhD
Outcome results
None listed