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: Chen Sarbagili-Shabat, Lindsey Albenberg, Johan Van Limbergen, Naomi Pressman, Anthony Otley, Michal Yaakov, Eytan Wine, Dror Weiner, Arie Levine
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Publicado: MDPI AG 2021
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Acceso en línea:https://doaj.org/article/67a29f78299a41b6b9f49197ab95dc42
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spelling oai:doaj.org-article:67a29f78299a41b6b9f49197ab95dc422021-11-25T18:33:37ZA Novel UC Exclusion Diet and Antibiotics for Treatment of Mild to Moderate Pediatric Ulcerative Colitis: A Prospective Open-Label Pilot Study10.3390/nu131137362072-6643https://doaj.org/article/67a29f78299a41b6b9f49197ab95dc422021-10-01T00:00:00Zhttps://www.mdpi.com/2072-6643/13/11/3736https://doaj.org/toc/2072-6643Background: 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 (<i>p</i> = 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 (<i>p</i> > 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.Chen Sarbagili-ShabatLindsey AlbenbergJohan Van LimbergenNaomi PressmanAnthony OtleyMichal YaakovEytan WineDror WeinerArie LevineMDPI AGarticleulcerative colitischilddietantibioticsremissiontreatmentNutrition. Foods and food supplyTX341-641ENNutrients, Vol 13, Iss 3736, p 3736 (2021)
institution DOAJ
collection DOAJ
language EN
topic ulcerative colitis
child
diet
antibiotics
remission
treatment
Nutrition. Foods and food supply
TX341-641
spellingShingle ulcerative colitis
child
diet
antibiotics
remission
treatment
Nutrition. Foods and food supply
TX341-641
Chen Sarbagili-Shabat
Lindsey Albenberg
Johan Van Limbergen
Naomi Pressman
Anthony Otley
Michal Yaakov
Eytan Wine
Dror Weiner
Arie Levine
A Novel UC Exclusion Diet and Antibiotics for Treatment of Mild to Moderate Pediatric Ulcerative Colitis: A Prospective Open-Label Pilot Study
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 (<i>p</i> = 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 (<i>p</i> > 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.
format article
author Chen Sarbagili-Shabat
Lindsey Albenberg
Johan Van Limbergen
Naomi Pressman
Anthony Otley
Michal Yaakov
Eytan Wine
Dror Weiner
Arie Levine
author_facet Chen Sarbagili-Shabat
Lindsey Albenberg
Johan Van Limbergen
Naomi Pressman
Anthony Otley
Michal Yaakov
Eytan Wine
Dror Weiner
Arie Levine
author_sort Chen Sarbagili-Shabat
title 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_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_sort novel uc exclusion diet and antibiotics for treatment of mild to moderate pediatric ulcerative colitis: a prospective open-label pilot study
publisher MDPI AG
publishDate 2021
url https://doaj.org/article/67a29f78299a41b6b9f49197ab95dc42
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