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Pancreatic enzyme supplementation versus placebo for improvement of gastrointestinal symptoms in non-responsive celiac disease: A cross-over randomized controlled trial
BACKGROUND: Pancreatic Exocrine Insufficiency (PEI) is a possible cause of recurrent/persistent symptoms in celiac disease. Although pancreatic enzyme supplementation may be used to treat non-responsive celiac disease (NRCD) in clinical practice, clinical outcomes are variable and there is limited a...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9845937/ https://www.ncbi.nlm.nih.gov/pubmed/36687454 http://dx.doi.org/10.3389/fmed.2022.1001879 |
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author | Yoosuf, Shakira Barrett, Caitlin G. Papamichael, Konstantinos Madoff, Sarah E. Kurada, Satya Hansen, Joshua Silvester, Jocelyn A. Therrien, Amelie Singh, Prashant Dennis, Melinda Leffler, Daniel A. Kelly, Ciaran P. |
author_facet | Yoosuf, Shakira Barrett, Caitlin G. Papamichael, Konstantinos Madoff, Sarah E. Kurada, Satya Hansen, Joshua Silvester, Jocelyn A. Therrien, Amelie Singh, Prashant Dennis, Melinda Leffler, Daniel A. Kelly, Ciaran P. |
author_sort | Yoosuf, Shakira |
collection | PubMed |
description | BACKGROUND: Pancreatic Exocrine Insufficiency (PEI) is a possible cause of recurrent/persistent symptoms in celiac disease. Although pancreatic enzyme supplementation may be used to treat non-responsive celiac disease (NRCD) in clinical practice, clinical outcomes are variable and there is limited and low quality evidence to support this practice. The aim of this study was to assess the efficacy of pancreatic enzyme supplements (PES) for improvement of gastrointestinal symptoms in NRCD. METHODS: Prospective, randomized, placebo-controlled, double-blind, cross-over trial in adults with NRCD examining Celiac Disease-Gastrointestinal Symptom Rating Scale (CeD-GSRS) scores on PES (pancrelipase co-administered with omeprazole) versus placebo (omeprazole only) during a 10-day treatment period. The study was registered under the clinical trials registry (https://clinicaltrials.gov/ number, NCT02475369) on 18 Jun 2015. RESULTS: Twelve participants (nine female) were included in the per-protocol analysis; one participant had low fecal elastase-1. Pancrelipase was not associated with significant change in CeD-GSRS compared to placebo (−0.03 versus −0.26; P = 0.366). There was a significant decrease in mean values of total CeD-GSRS scores (3.58 versus 2.90, P = 0.004), abdominal pain (2.92 versus 2.42, P = 0.009), and diarrhea sub-scores (3.44 versus 2.92, P = 0.037) during the run-in period with omeprazole. CONCLUSION: In this prospective, cross-over randomized, placebo-controlled study, PES did not improve symptoms in patients with NRCD. It is unclear whether this is a trial effect or related to administration of omeprazole. |
format | Online Article Text |
id | pubmed-9845937 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-98459372023-01-19 Pancreatic enzyme supplementation versus placebo for improvement of gastrointestinal symptoms in non-responsive celiac disease: A cross-over randomized controlled trial Yoosuf, Shakira Barrett, Caitlin G. Papamichael, Konstantinos Madoff, Sarah E. Kurada, Satya Hansen, Joshua Silvester, Jocelyn A. Therrien, Amelie Singh, Prashant Dennis, Melinda Leffler, Daniel A. Kelly, Ciaran P. Front Med (Lausanne) Medicine BACKGROUND: Pancreatic Exocrine Insufficiency (PEI) is a possible cause of recurrent/persistent symptoms in celiac disease. Although pancreatic enzyme supplementation may be used to treat non-responsive celiac disease (NRCD) in clinical practice, clinical outcomes are variable and there is limited and low quality evidence to support this practice. The aim of this study was to assess the efficacy of pancreatic enzyme supplements (PES) for improvement of gastrointestinal symptoms in NRCD. METHODS: Prospective, randomized, placebo-controlled, double-blind, cross-over trial in adults with NRCD examining Celiac Disease-Gastrointestinal Symptom Rating Scale (CeD-GSRS) scores on PES (pancrelipase co-administered with omeprazole) versus placebo (omeprazole only) during a 10-day treatment period. The study was registered under the clinical trials registry (https://clinicaltrials.gov/ number, NCT02475369) on 18 Jun 2015. RESULTS: Twelve participants (nine female) were included in the per-protocol analysis; one participant had low fecal elastase-1. Pancrelipase was not associated with significant change in CeD-GSRS compared to placebo (−0.03 versus −0.26; P = 0.366). There was a significant decrease in mean values of total CeD-GSRS scores (3.58 versus 2.90, P = 0.004), abdominal pain (2.92 versus 2.42, P = 0.009), and diarrhea sub-scores (3.44 versus 2.92, P = 0.037) during the run-in period with omeprazole. CONCLUSION: In this prospective, cross-over randomized, placebo-controlled study, PES did not improve symptoms in patients with NRCD. It is unclear whether this is a trial effect or related to administration of omeprazole. Frontiers Media S.A. 2023-01-04 /pmc/articles/PMC9845937/ /pubmed/36687454 http://dx.doi.org/10.3389/fmed.2022.1001879 Text en Copyright © 2023 Yoosuf, Barrett, Papamichael, Madoff, Kurada, Hansen, Silvester, Therrien, Singh, Dennis, Leffler and Kelly. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Medicine Yoosuf, Shakira Barrett, Caitlin G. Papamichael, Konstantinos Madoff, Sarah E. Kurada, Satya Hansen, Joshua Silvester, Jocelyn A. Therrien, Amelie Singh, Prashant Dennis, Melinda Leffler, Daniel A. Kelly, Ciaran P. Pancreatic enzyme supplementation versus placebo for improvement of gastrointestinal symptoms in non-responsive celiac disease: A cross-over randomized controlled trial |
title | Pancreatic enzyme supplementation versus placebo for improvement of gastrointestinal symptoms in non-responsive celiac disease: A cross-over randomized controlled trial |
title_full | Pancreatic enzyme supplementation versus placebo for improvement of gastrointestinal symptoms in non-responsive celiac disease: A cross-over randomized controlled trial |
title_fullStr | Pancreatic enzyme supplementation versus placebo for improvement of gastrointestinal symptoms in non-responsive celiac disease: A cross-over randomized controlled trial |
title_full_unstemmed | Pancreatic enzyme supplementation versus placebo for improvement of gastrointestinal symptoms in non-responsive celiac disease: A cross-over randomized controlled trial |
title_short | Pancreatic enzyme supplementation versus placebo for improvement of gastrointestinal symptoms in non-responsive celiac disease: A cross-over randomized controlled trial |
title_sort | pancreatic enzyme supplementation versus placebo for improvement of gastrointestinal symptoms in non-responsive celiac disease: a cross-over randomized controlled trial |
topic | Medicine |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9845937/ https://www.ncbi.nlm.nih.gov/pubmed/36687454 http://dx.doi.org/10.3389/fmed.2022.1001879 |
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