SEARCHRCTgastroenterology, clinical nutrition

RCT·gastroenterology, clinical nutrition, nutrition, vitamins, clinical trial·PMC10016306

Effects of ileocolonic delivered vitamin B 2 , B 3 and C (ColoVit) or the Groningen anti-inflammatory diet on disease course and microbiome of patients with Crohn’s disease (VITA-GrAID study): a protocol for a randomised and partially blinded trial

BMJ Open · 10 authors, 4 centres

AI SUMMARY

FIDELITY 100%

POPULATIONCrohn's disease patients with Harvey-Bradshaw Index <8 and faecal calprotectin ≥100 µg/g at baseline

INTERVENTIONGroningen anti-inflammatory diet (GrAID) or ileocolonic-delivered vitamin B2/B3/C capsule (ColoVit)

COMPARISONPlacebo group

This summary was generated by AI from a single paper. It has not been reviewed by a clinician and is not clinical advice. Verify against the source before acting on it.

AGENT 01 · STRUCTURED SUMMARY

TRACE TO SOURCE

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TL;DR

This is a protocol for a randomised, placebo-controlled trial to test if a targeted vitamin supplement or a specific anti-inflammatory diet can reduce intestinal inflammation in Crohn's disease patients, measured by changes in faecal calprotectin.

Full summary

537 CHARS

This is a protocol for a multicentre, randomised, placebo-controlled, partially blinded trial. It plans to recruit 255 Crohn's disease patients and their healthy household members. Patients will be randomised to a 12-week intervention with either the Groningen anti-inflammatory diet or an ileocolonic-delivered vitamin capsule, compared to a placebo. The primary outcome for patients is the change in faecal calprotectin level. Secondary outcomes include gut microbial composition, flare rates, clinical parameters, and quality of life.

PICO

PPOPULATION

Crohn's disease patients with Harvey-Bradshaw Index <8 and faecal calprotectin ≥100 µg/g at baseline

IINTERVENTION

Groningen anti-inflammatory diet (GrAID) or ileocolonic-delivered vitamin B2/B3/C capsule (ColoVit)

OOUTCOME

Change in faecal calprotectin from baseline after 12-week intervention

STUDY TYPE

RCT

SPECIALTY

gastroenterology

SUMMARISED BY

AI pipeline

FIDELITY CHECK

100% · A

ORIGINAL PAPER

PMC10016306

Effects of ileocolonic delivered vitamin B 2 , B 3 and C (ColoVit) or the Groningen anti-inflammatory diet on disease course and microbiome of patients with Crohn’s disease (VITA-GrAID study): a protocol for a randomised and partially blinded trial

BMJ Open

READ THE FULL PAPER

ABSTRACT

Background Diet plays a pivotal role in the onset and progression of Crohn’s disease (CD). Nutritional interventions revealed effects on intestinal inflammation and gut microbial composition. However, data from well-designed and controlled dietary trials are lacking. Therefore, evidence-based dietary recommendations are still unavailable to patients and physicians. Here, we aim to investigate the effects of an evidence-based anti-inflammatory diet, and an ileocolonic-targeted capsule containing vitamin B 2 , B 3 and C (ColoVit) on patients with CD and their healthy household members. Methods and analysis In this multicentre, randomised, placebo-controlled, partially blinded nutritional intervention trial, we aim to recruit 255 CD patients with Harvey-Bradshaw Index <8 and a faecal calprotectin (FCal) cut-off of ≥100 µg/g at baseline. Participants will be randomised into two experimental intervention groups and one placebo group. In the experimental groups, participants will either adhere to the Groningen anti-inflammatory diet (GrAID) or ingest an ileocolonic-delivered oral vitamin B 2 /B 3 /C capsule (ColoVit). The study consists of a 12-week controlled interventional phase, which proceeds to a 9-month observational follow-up phase in which patients allocated to the GrAID group will be requested to continue the intervention on their own accord. Household members of participating patients will be asked to participate in the trial as healthy subjects and are allocated to the same group as their peer. The primary study outcome for patients is the change in FCal level from baseline. The primary outcome for household members is the change in gut microbial composition, which is set as secondary outcome for patients. Ethics and dissemination The protocol has been approved by the Institutional Review Board of the Stichting Beoordeling Ethiek Biomedisch Onderzoek in Assen, the Netherlands. Written informed consent will be obtained from all participants. Results will be disseminated through peer-reviewed journals and conference presentations. Trial registration number NCT04913467 .

CITATION EXPORT

Antonius Timotheus Otten, V Peters, I Barth et al.. Effects of ileocolonic delivered vitamin B2, B3 and C (ColoVit) or the Groningen anti-inflammatory diet on disease course and microbiome of patients with Crohn’s disease (VITA-GrAID study): a protocol for a randomised and partially blinded trial. BMJ Open. (2023). https://doi.org/10.1136/bmjopen-2022-069654

AUTHORS

10 · 4 CENTRES

Antonius Timotheus Otten, V Peters, I Barth, C L Stevens, A R Bourgonje, H W Frijlink, H J M Harmsen, A Rehman, M J E Campmans-Kuijpers, G Dijkstra

1Department of Gastroenterology and Hepatology, University Medical Centre Groningen, Groningen, The Netherlands
2Pharmaceutical Technology and Biopharmacy, University of Groningen, Groningen, The Netherlands
3Department of Medical Microbiology, University Medical Centre Groningen, Groningen, The Netherlands
4DSM Nutritional Products AG, Kaiseraugst, Switzerland