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

NCT04913467 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 510

Last updated 2023-02-14

No results posted yet for this study

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.

Conditions

  • Crohn Disease

Interventions

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

Sponsors & Collaborators

  • University Medical Center Groningen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-08
Primary Completion
2024-07-01
Completion
2025-07-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04913467 on ClinicalTrials.gov