Potential Effects of Ileocolonic 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

Status: Unknown
Location: See location...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
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• 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)

• 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)

Locations
Other Locations
Netherlands
University Medical Center Groningen
RECRUITING
Groningen
Contact Information
Primary
Gerard Dijkstra, MD PhD
gerard.dijkstra@umcg.nl
+31 050 3612620
Time Frame
Start Date: 2021-10-08
Completion Date: 2025-07-01
Participants
Target number of participants: 510
Treatments
Experimental: Groningen Anti-Inflammatory Diet (GrAID)
Specially designed diet based on the most recent scientific evidence of the inflammatory characteristics of food and food groups.
Experimental: ColoVit capsule
2 times daily intake of a supplement containing 37,5 mg vitamin B2, 2,5 mg vitamin B3 and 250 mg vitamin C in a ColoPulse-coated capsule, a pH-sensitive coating allowing ileocolonic-targeted-delivery
Placebo_comparator: Placebo capsule
2 times daily intake of a capsule containing microcrystalline cellulose which is coated using the same ColoPulse technology as is used with the ColoVit
Related Therapeutic Areas
Sponsors
Leads: University Medical Center Groningen

This content was sourced from clinicaltrials.gov