Sistema de Salut de Catalunya
Institut Català de la Salut
[Petrisor DC] Department of Gastroenterology, Endodigest Medical Center, Oradea, Romania. [Etropolska Z] Department of Gastroenterology, Ambulatory Practice for Primary Outpatient Medical Care SANA, Sofa, Bulgaria. [Elenski K] Department of Gastroenterology, BROD – Ambulatory Practice for Primary Medical Care, Plovdiv, Bulgaria. [Dimitrova E] Department of Gastroenterology, Medical Centre Prolet, Ruse, Bulgaria. [Santos J] Laboratori de Neuroimmuno-Gastroenterologia, Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. Servei d’Aparell Digestiu, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Servei d’Aparell Digestiu, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERHED), Instituto de Salud Carlos III, Madrid, Spain
Vall d'Hebron Barcelona Hospital Campus
2024-01-30T12:48:22Z
2024-01-30T12:48:22Z
2024-01
Functional abdominal bloating and distension; Pea protein; Simethicone
Inflor i distensió abdominal funcional; Proteïna de pèsol; Simeticona
Hinchazón y distensión abdominal funcional; Proteína de guisante; Simeticona
Background Functional Abdominal Bloating and Distension (FABD) is a multifaceted condition related in part to trapped gas, with changes in the intestinal barrier and small intestinal bacterial overgrowth (SIBO), which lead to gas production. Currently, there are no treatments targeting the etiology of FABD. Methods This double-blind, multicenter, randomized study evaluated the safety and efficacy of a product containing xyloglucan and pea proteins (XG + PP) compared with simethicone, both administered orally (three times daily) for 20 consecutive days. Eighty-eight patients with FABD were randomly assigned to the two groups in a 1:1 ratio. Primary outcome was safety; secondary outcomes were (i) efficacy in alleviating the symptoms of FABD and (ii) efficacy in reducing SIBO, as assessed by hydrogen breath test (HBT). Results No Adverse Events or Serious Unexpected Adverse Reactions were reported during the study. XG + PP showed a faster onset of action and a significant reduction in bloating and abdominal pain compared with simethicone. At Day 20, XG + PP drastically reduced abdominal girth when compared with simethicone, with an average reduction of 4.7 cm versus 1.8 cm. At Day 20, the XG + PP arm showed a significant reduction in HBT compared to baseline. Conclusions This study supports the evidence that FABD patients may benefit from a XG + PP-based treatment that acts on etiology and not just the symptoms.
The study was sponsored by Devintec Sagl.
Article
Published version
English
Abdomen - Malalties - Patogènesi; Avaluació de resultats (Assistència sanitària); Abdomen - Malalties - Tractament; DISEASES::Pathological Conditions, Signs and Symptoms::Pathological Conditions, Anatomical::Dilatation, Pathologic; ANATOMY::Body Regions::Torso::Abdomen; Other subheadings::Other subheadings::Other subheadings::/pathology; ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome; ENFERMEDADES::afecciones patológicas, signos y síntomas::afecciones patológicas anatómicas::dilatación patológica; ANATOMÍA::regiones corporales::tronco::abdomen; Otros calificadores::Otros calificadores::Otros calificadores::/patología; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento
Springer
Digestive Diseases and Sciences;69
https://doi.org/10.1007/s10620-023-08155-1
Attribution-NonCommercial 4.0 International
http://creativecommons.org/licenses/by-nc/4.0/
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