Crohn's Disease IBD
Conditions
Interventions
Intervention:
- Group 1 who will follow the Groningen Anti-Inflammatory diet (GrAID) and
receive a food box for three months
- Group 2 who will receive a vitamin B2/B3/C delivered to the ileocolonic
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients are eligible to participate in this study if they meet all of the following criteria: • Signed an informed consent • Previously diagnosed with CD • Low-mild disease activity (no clinically relevant symptoms and HBI=100 µg/g) • Able to attend to the outpatient clinic • >18 years of age • Able to use oral feeding and willing to undergo a dietary intervention (use food out of the food boxes or use a vitamin B2/B3/C supplement or placebo) Concomitant medication for CD is allowed (except for Methotrexate drugs, see exclusion criteria) and will be continued and monitored during the complete study. Healthy participants are eligible to participate in this study if they meet all the following criteria: • Signed an informed consent • Never been diagnosed with IBD • Able to attend to the outpatient clinic • >=18 year of age • Able to use oral feeding and willing to undergo a dietary intervention (use food out of the food boxes or use a vitamin B2/B3/C supplement or placebo)
Exclusion criteria
Exclusion criteria: Patients and healthy volunteers will be excluded from the study is they meet any of the following criteria: • Life expectancy =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 proton pump inhibitors • GI resection or a history of GI conditions that in the judgment of the investigator could possibly interfere with the working mechanism of the pH-sensitive ColoPulse coating • Patients with a pouch or stoma • Pregnant or breastfeeding • 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 Coeliac Disease • Following a vegetarian or vegan diet
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoints are divided into three research areas and differs for patients and healthy participants. Overview of measurements conducted in CD patients and healthy participants can be found in more detail in the protocol. Clinical objective: a. the number of flares (defined as faecal calprotectin >200 µg/g and CDAI >=220) (secondary outcome CD patients), measured after 3, 6 and 12 months b. the quality of life (IBDQ), at 0, 3, 6 and 12 months Mechanical objective c. faecal sampling: the composition of microbiota and microbiome diversity (primary outcome for healthy participants) at 0, 3, and 12 (only in GrAID) months d. faecal parameters: calprotectin (primary outcome for IBD patients), faecal pH, Short Chain Fatty Acids (SCFAs), faecal redox potential (secondary outcome) at 0, 3 and 12(only in GrAID) months e. Inflammatory parameters (CRP) and redox parameters (free thiols) (blood samples) at 0, 3, 6 and 12 months in CD patients and at 0 and 3 months in healthy participants Societal objective: f. compliance outcomes: follow-up compliance. (at 3 months for all groups and at 6 and 12 months for the dietary group) | — |
Secondary
| Measure | Time frame |
|---|---|
| See primary study parameters for a quick overview and please refer to the protocol for a more elaborate overview of the endpoints and parameters) | — |
Countries
Netherlands
Outcome results
None listed