Pancreatic enzyme supplementation versus placebo for improvement of gastrointestinal symptoms in non-responsive celiac disease: A cross-over randomized controlled trial

Abstract

BackgroundPancreatic 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.MethodsProspective, 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.ResultsTwelve 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.ConclusionIn 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.

The Gluten-Free Diet for Celiac Disease: Critical Insights to Better Understand Clinical Outcomes

“…In this context, dietary transgressions are an essential bias in interpreting the clinical course of these patients [ 12 , 16 , 138 ]. An associated pathology is the actual cause of the ongoing symptoms: microscopic colitis [ 147 , 148 , 149 , 150 ], SIBO [ 151 , 152 , 153 , 154 ], malabsorption of simple carbohydrates (e.g., lactose, fructose, or sorbitol) [ 155 , 156 , 157 ], and others such as reflux dysmotility [ 135 ], PEI [ 158 , 159 ], idiopathic bile salt malabsorption [ 160 , 161 , 162 ], Crohn’s disease, [ 163 , 164 , 165 , 166 , 167 , 168 , 169 , 170 , 171 , 172 , 173 ], and other functional digestive disorders, including irritable bowel syndrome [ 174 , 175 , 176 ]. In such patients, it is obvious that the nature of the symptoms is due to a different cause that overlaps with that of CeD itself.…”