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

Not Applicable

Recruiting

• Conditions: Crohn Disease
• Interventions: Other: Groningen Anti-Inflammatory Diet (GrAID); Dietary Supplement: ColoVit capsule; Other: ColoPulse-placebo capsule

• Registration Number: NCT04913467
• Lead Sponsor: University Medical Center Groningen

Brief 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.

Study Timeline

• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-28
• Study First Posted: 2021-06-04
• Study Start: 2021-10-08
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-10
• Last Update Posted: 2023-02-14
• Primary Completion: 2024-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 510

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Groningen Anti-Inflammatory Diet (GrAID)	Groningen Anti-Inflammatory Diet (GrAID)	Specially designed diet based on the most recent scientific evidence of the inflammatory characteristics of food and food groups.
ColoVit capsule	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 capsule	ColoPulse-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

Primary Outcome Measures

Name	Time	Method
Change in faecal calprotectin	Faeces sample collection at 4 time points: At baseline (0 months), after 3 months, after 6 months, after 12 months	Primary outcome for CD patients
Change in microbiome composition measured by metagenomic sequencing- based profiles	Faeces sample collection at 3 time points: At baseline (0 months), after 3 months, after 12 months	Primary outcome for healthy volunteers and CD patients

Secondary Outcome Measures

Name	Time	Method
The number of flares (defined as faecal calprotectin >200 μg/g and Crohn's Disease Activity Index (CDAI) ≥220 points)	Faeces sample collection and CDAI score determination at 4 time points: At baseline (0 months), after 3 months, after 6 months, after 12 months	Secondary outcome for CD patients
Improvements of Quality of life scores as assessed by Inflammatory Bowel Disease Questionnaire (Score range of 32-224, The higher the score the higher the Quality of Life)	Questionnaires at 3 time points: At baseline (0 months), after 3 months, after 12 months	Secondary outcome for CD patients
Improvements of Quality of life scores as assessed Food Related Quality of Life Questionnaire (Score range of 29-145, The higher the score the higher the Food related-Quality of Life)	Questionnaires at 3 time points: At baseline (0 months), after 3 months, after 12 months	Secondary outcome for CD patients and healthy volunteers
Adherence to the dietary interventions as assessed by a Dietary Compliance Questionnaire	Questionnaires at 3 time points: At baseline (0 months), after 3 months, after 12 months	Secondary outcome for CD patients and healthy volunteers

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands