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A Novel UC Exclusion Diet and Antibiotics for Treatment of Mild to Moderate Pediatric Ulcerative Colitis: A Prospective Open-Label Pilot Study

Background: As the microbiome plays an important role in instigating inflammation in ulcerative colitis (UC), strategies targeting the microbiome may offer an alternative therapeutic approach. The goal of the pilot trial was to evaluate the potential efficacy and feasibility of a novel UC exclusion...

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Autores principales: Sarbagili-Shabat, Chen, Albenberg, Lindsey, Van Limbergen, Johan, Pressman, Naomi, Otley, Anthony, Yaakov, Michal, Wine, Eytan, Weiner, Dror, Levine, Arie
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8622458/
https://www.ncbi.nlm.nih.gov/pubmed/34835992
http://dx.doi.org/10.3390/nu13113736
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author Sarbagili-Shabat, Chen
Albenberg, Lindsey
Van Limbergen, Johan
Pressman, Naomi
Otley, Anthony
Yaakov, Michal
Wine, Eytan
Weiner, Dror
Levine, Arie
author_facet Sarbagili-Shabat, Chen
Albenberg, Lindsey
Van Limbergen, Johan
Pressman, Naomi
Otley, Anthony
Yaakov, Michal
Wine, Eytan
Weiner, Dror
Levine, Arie
author_sort Sarbagili-Shabat, Chen
collection PubMed
description Background: As the microbiome plays an important role in instigating inflammation in ulcerative colitis (UC), strategies targeting the microbiome may offer an alternative therapeutic approach. The goal of the pilot trial was to evaluate the potential efficacy and feasibility of a novel UC exclusion diet (UCED) for clinical remission, as well as the potential of sequential antibiotics for diet-refractory patients to achieve remission without steroids. Methods: This was a prospective, single-arm, multicenter, open-label pilot study in patients aged 8–19, with pediatric UC activity index (PUCAI) scores >10 on stable maintenance therapy. Patients failing to enter remission (PUCAI < 10) on the diet could receive a 14-day course of amoxycillin, metronidazole and doxycycline (AMD), and were re-assessed on day 21. The primary endpoint was intention-to-treat (ITT) remission at week 6, with UCED as the only intervention. Results: Twenty-four UCED treatment courses were given to 23 eligible children (mean age: 15.3 ± 2.9 years). The median PUCAI decreased from 35 (30–40) at baseline to 12.5 (5–30) at week 6 (p = 0.001). Clinical remission with UCED alone was achieved in 9/24 (37.5%). The median fecal calprotectin declined from 818 (630.0–1880.0) μg/g at baseline to 592.0 (140.7–1555.0) μg/g at week 6 (p > 0.05). Eight patients received treatment with antibiotics after failing on the diet; 4/8 (50.0%) subsequently entered remission 3 weeks later. Conclusion: The UCED appears to be effective and feasible for the induction of remission in children with mild to moderate UC. The sequential use of UCED followed by antibiotic therapy needs to be evaluated as a microbiome-targeted, steroid-sparing strategy.
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spelling pubmed-86224582021-11-27 A Novel UC Exclusion Diet and Antibiotics for Treatment of Mild to Moderate Pediatric Ulcerative Colitis: A Prospective Open-Label Pilot Study Sarbagili-Shabat, Chen Albenberg, Lindsey Van Limbergen, Johan Pressman, Naomi Otley, Anthony Yaakov, Michal Wine, Eytan Weiner, Dror Levine, Arie Nutrients Article Background: As the microbiome plays an important role in instigating inflammation in ulcerative colitis (UC), strategies targeting the microbiome may offer an alternative therapeutic approach. The goal of the pilot trial was to evaluate the potential efficacy and feasibility of a novel UC exclusion diet (UCED) for clinical remission, as well as the potential of sequential antibiotics for diet-refractory patients to achieve remission without steroids. Methods: This was a prospective, single-arm, multicenter, open-label pilot study in patients aged 8–19, with pediatric UC activity index (PUCAI) scores >10 on stable maintenance therapy. Patients failing to enter remission (PUCAI < 10) on the diet could receive a 14-day course of amoxycillin, metronidazole and doxycycline (AMD), and were re-assessed on day 21. The primary endpoint was intention-to-treat (ITT) remission at week 6, with UCED as the only intervention. Results: Twenty-four UCED treatment courses were given to 23 eligible children (mean age: 15.3 ± 2.9 years). The median PUCAI decreased from 35 (30–40) at baseline to 12.5 (5–30) at week 6 (p = 0.001). Clinical remission with UCED alone was achieved in 9/24 (37.5%). The median fecal calprotectin declined from 818 (630.0–1880.0) μg/g at baseline to 592.0 (140.7–1555.0) μg/g at week 6 (p > 0.05). Eight patients received treatment with antibiotics after failing on the diet; 4/8 (50.0%) subsequently entered remission 3 weeks later. Conclusion: The UCED appears to be effective and feasible for the induction of remission in children with mild to moderate UC. The sequential use of UCED followed by antibiotic therapy needs to be evaluated as a microbiome-targeted, steroid-sparing strategy. MDPI 2021-10-23 /pmc/articles/PMC8622458/ /pubmed/34835992 http://dx.doi.org/10.3390/nu13113736 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Sarbagili-Shabat, Chen
Albenberg, Lindsey
Van Limbergen, Johan
Pressman, Naomi
Otley, Anthony
Yaakov, Michal
Wine, Eytan
Weiner, Dror
Levine, Arie
A Novel UC Exclusion Diet and Antibiotics for Treatment of Mild to Moderate Pediatric Ulcerative Colitis: A Prospective Open-Label Pilot Study
title A Novel UC Exclusion Diet and Antibiotics for Treatment of Mild to Moderate Pediatric Ulcerative Colitis: A Prospective Open-Label Pilot Study
title_full A Novel UC Exclusion Diet and Antibiotics for Treatment of Mild to Moderate Pediatric Ulcerative Colitis: A Prospective Open-Label Pilot Study
title_fullStr A Novel UC Exclusion Diet and Antibiotics for Treatment of Mild to Moderate Pediatric Ulcerative Colitis: A Prospective Open-Label Pilot Study
title_full_unstemmed A Novel UC Exclusion Diet and Antibiotics for Treatment of Mild to Moderate Pediatric Ulcerative Colitis: A Prospective Open-Label Pilot Study
title_short A Novel UC Exclusion Diet and Antibiotics for Treatment of Mild to Moderate Pediatric Ulcerative Colitis: A Prospective Open-Label Pilot Study
title_sort novel uc exclusion diet and antibiotics for treatment of mild to moderate pediatric ulcerative colitis: a prospective open-label pilot study
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8622458/
https://www.ncbi.nlm.nih.gov/pubmed/34835992
http://dx.doi.org/10.3390/nu13113736
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