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.
| Autor: | Otten AT; Department of Gastroenterology and Hepatology, University Medical Centre Groningen, Groningen, The Netherlands a.t.otten@umcg.nl., Peters V; Department of Gastroenterology and Hepatology, University Medical Centre Groningen, Groningen, The Netherlands., Barth I; Department of Gastroenterology and Hepatology, University Medical Centre Groningen, Groningen, The Netherlands., Stevens CL; Department of Gastroenterology and Hepatology, University Medical Centre Groningen, Groningen, The Netherlands., Bourgonje AR; Department of Gastroenterology and Hepatology, University Medical Centre Groningen, Groningen, The Netherlands., Frijlink HW; Pharmaceutical Technology and Biopharmacy, University of Groningen, Groningen, The Netherlands., Harmsen HJM; Department of Medical Microbiology, University Medical Centre Groningen, Groningen, The Netherlands., Rehman A; DSM Nutritional Products AG, Kaiseraugst, Switzerland., Campmans-Kuijpers MJE; Department of Gastroenterology and Hepatology, University Medical Centre Groningen, Groningen, The Netherlands., Dijkstra G; Department of Gastroenterology and Hepatology, University Medical Centre Groningen, Groningen, The Netherlands. |
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| Jazyk: | angličtina |
| Zdroj: | BMJ open [BMJ Open] 2023 Mar 14; Vol. 13 (3), pp. e069654. Date of Electronic Publication: 2023 Mar 14. |
| DOI: | 10.1136/bmjopen-2022-069654 |
| Abstrakt: | 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 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 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. Competing Interests: Competing interests: GD received a research grant from Royal DSM and received speaker fees from Pfizer, Abbvie and Janssen Pharmaceuticals. All other authors have no conflicts of interest to declare. (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.) |
| Databáze: | MEDLINE |
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