Potential effects of ileo-colonic delivered Vitamins or the Groningen Anti-Inflammatory Diet on course of Crohn*s Disease and the microbiome of healthy volunteers: a randomized controlled trial - The Vita-GrAID study

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 510

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; Montreal classification: L1 (Ileal) or L3
(ileocolonic).
• Low-mild disease activity (no clinically relevant symptoms and HBI<8 and 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 Diaconessenhuis Meppel
• >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 of the UMCG, Martini Hospital, MCL
Leeuwarden or Isala Diaconessenhuis Meppel
• >=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

Patients and healthy volunteers will be excluded from the study is they meet
any of the following criteria:
• Life expectancy <12 months
• Active Crohn's disease (HBI>=8 and 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
• History of surgery:
o Presence of a pouch
o Presence of a 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