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Corporal composition and gut microbiome modification through exclusion dietary intervention in adult patients with Crohn’s disease: protocol for a prospective, interventional, controlled, randomized clinical trial

dc.contributor.authorCano-Mármol, Rosario Paloma
dc.contributor.authorFernández Ruiz, Virginia Esperanza
dc.contributor.authorMartínez-Pascual, Cristina
dc.contributor.authorRos-Madrid, Inmaculada
dc.contributor.authorMartín-Pozuelo del Pozo, Gala
dc.contributor.authorOliva-Bolarín, Alba
dc.contributor.authorMartínez-Sánchez, María Antonia
dc.contributor.authorEgea Valenzuela, Juan
dc.contributor.authorNúñez-Sánchez, María Ángeles
dc.contributor.authorRamos-Molina, Bruno
dc.contributor.authorRuiz Alcaraz, Antonio José
dc.contributor.authorFerrer Gómez, Mercedes
dc.contributor.departmentBioquímica y Biología Molecular B e Inmunología
dc.contributor.otherFacultad de Biología
dc.date.accessioned2026-01-14T07:05:44Z
dc.date.available2026-01-14T07:05:44Z
dc.date.copyright© 2025 by the authors
dc.date.issued2025-06-05
dc.description.abstractBackground: Crohn’s disease (CD) is an inflammatory bowel disease in which there is an alteration in the homeostasis and functionality of the intestinal mucosa accompanied by a dysbiosis of the commensal microbiota. The analysis of different dietary strategies to achieve CD remission and reduce gastrointestinal symptoms concludes that it is necessary to restrict the intake of ultra-processed products and to promote the consumption of those with anti-inflammatory effects that improve intestinal permeability and dysbiosis. Methods: Based on previous studies conducted in other cohorts, mainly pediatric, we propose an experimental, prospective, randomized study in patients with active CD who do not show improvement with conventional pharmacological treatment. The control group will receive standard nutritional recommendations while the intervention group will be prescribed an exclusion diet supplemented with enteral nutrition. Results: Patients in the intervention group are expected to exhibit increased lean body mass and reduced visceral fat, as measured by bioelectrical impedance analysis (BIA), alongside higher rates of clinical remission (CDAI), decreased inflammatory markers, and improved gut microbiota composition. Additionally, improvements in health-related quality of life are anticipated, as assessed by validated questionnaires. Conclusions: In the present project, we plan to conduct a detailed study to determine the potential of the exclusion diet for the treatment and remission of CD in adult patients, with the hypothesis that this nutritional intervention will be able to modify and improve intestinal dysbiosis, inflammatory status, and clinical and body composition markers in these patients.
dc.formatapplication/pdf
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dc.identifier.citationJ. Clin. Med. 2025, 14, 3998
dc.identifier.doihttps://doi.org/10.3390/jcm14113998
dc.identifier.eissn2077-0383
dc.identifier.urihttp://hdl.handle.net/10201/186470
dc.languageeng
dc.publisherMDPI
dc.relationThis research was funded by the Spanish Society of Endocrinology and Nutrition (SEEN) Foundation, the Robles Chillida Foundation, and Vegenat Healthcare Laboratories. I.R.-M. was supported by a Rio Hortega contract from the ISCIII (CM24/00019; co-funded by the Fondo Europeo de Desarrollo Regional-FEDER). M.A.M-S. was supported by a PFIS contract from the ISCIII (FI21/00003; co-funded by the Fondo Europeo de Desarrollo Regional-FEDER). M.A.N.-S. was supported by a Miguel Servet contract from the ISCIII (CP23/00051; co-funded by the European Union).
dc.relation.publisherversionhttps://www.mdpi.com/2077-0383/14/11/3998
dc.rightsAttribution 4.0 International*
dc.rights.accessRightsinfo:eu-repo/semantics/openAccess
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/*
dc.subjectExclusion diet
dc.subjectGut microbiome
dc.subjectCorporal composition
dc.subjectCrohn’s disease
dc.subject.odsNo relacionado con ningún objetivo de desarrollo sostenible
dc.titleCorporal composition and gut microbiome modification through exclusion dietary intervention in adult patients with Crohn’s disease: protocol for a prospective, interventional, controlled, randomized clinical trial
dc.typeinfo:eu-repo/semantics/article
dc.type.versioninfo:eu-repo/semantics/publishedVersion
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