NCT04913467

Effect of Ileocolonic Delivered Vitamins and an Anti-Inflammatory Diet on Crohn's Disease and Healthy Volunteers

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 510 (estimated)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
OTHER	Groningen 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_SUPPLEMENT	ColoVit capsule	Vitamin B2/B3/C supplement in a ColoPulse-coated capsule
OTHER	ColoPulse-placebo capsule	A capsule containing microcrystalline cellulose which is coated using the same ColoPulse technology as is used with the ColoVit

Timeline

• Start date: 2021-10-08
• Primary completion: 2024-07-01
• Completion: 2025-07-01
• First posted: 2021-06-04
• Last updated: 2023-02-14

Locations

1 site across 1 country: Netherlands