Home parenteral nutrition with an omega-3-fatty-acid-enriched MCT/LCT lipid emulsion in patients with chronic intestinal failure (the HOME study):study protocol for a randomized, controlled, multicenter, international clinical trial

BACKGROUND: Home parenteral nutrition (HPN) is a life-preserving therapy for patients with chronic intestinal failure (CIF) indicated for patients who cannot achieve their nutritional requirements by enteral intake. Intravenously administered lipid emulsions (ILEs) are an essential component of HPN, providing energy and essential fatty acids, but can become a risk factor for intestinal-failure-associated liver disease (IFALD). In HPN patients, major effort is taken in the prevention of IFALD. Novel ILEs containing a proportion of omega-3 polyunsaturated fatty acids (n-3 PUFA) could be of benefit, but the data on the use of n-3 PUFA in HPN patients are still limited. METHODS/DESIGN: The HOME study is a prospective, randomized, controlled, double-blind, multicenter, international clinical trial conducted in European hospitals that treat HPN patients. A total of 160 patients (80 per group) will be randomly assigned to receive the n-3 PUFA-enriched medium/long-chain triglyceride (MCT/LCT) ILE (Lipidem/Lipoplus® 200 mg/ml, B. Braun Melsungen AG) or the MCT/LCT ILE (Lipofundin® MCT/LCT/Medialipide® 20%, B. Braun Melsungen AG) for a projected period of 8 weeks. The primary endpoint is the combined change of liver function parameters (total bilirubin, aspartate transaminase and alanine transaminase) from baseline to final visit. Secondary objectives are the further evaluation of the safety and tolerability as well as the efficacy of the ILEs. DISCUSSION: Currently, there are only very few randomized controlled trials (RCTs) investigating the use of ILEs in HPN, and there are very few data at all on the use of n-3 PUFAs. The working hypothesis is that n-3 PUFA-enriched ILE is safe and well-tolerated especially with regard to liver function in patients requiring HPN. The expected outcome is to provide reliable data to support this thesis thanks to a considerable number of CIF patients, consequently to broaden the present evidence on the use of ILEs in HPN. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03282955. Registered on 14 September 2017

Trials

BACKGROUND: Postoperative upper gastrointestinal fistula (PUGIF) is a devastating complication, leading to high mortality (reaching up to 80%), increased length of hospital stay, reduced health-related quality of life and increased health costs. Nutritional support is a key component of therapy in such cases, which is related to the high prevalence of malnutrition. In the prophylactic setting, enteral nutrition (EN) is associated with a shorter hospital stay, a lower incidence of severe infectious complications, lower severity of complications and decreased cost compared to total parenteral nutrition (TPN) following major upper gastrointestinal (GI) surgery. There is little evidence available for the curative setting after fistula occurrence. We hypothesize that EN increases the 30-day fistula closure rate in PUGIF, allowing better health-related quality of life without increasing the morbidity or mortality. METHODS/DESIGN: The NUTRILEAK trial is a multicenter, randomized, parallel-group, open-label phase III trial to assess the efficacy of EN (the experimental group) compared with TPN (the control group) in patients with PUGIF. The primary objective of the study is to compare EN versus TPN in the treatment of PUGIF (after esophagogastric resection including bariatric surgery, duodenojejunal resection or pancreatic resection with digestive tract violation) in terms of the 30-day fistula closure rate. Secondary objectives are to evaluate the 6-month postrandomization fistula closure rate, time of first fistula closure (in days), the medical- and surgical treatment-related complication rate at 6 months after randomization, the fistula-related complication rate at 6 months after randomization, the type and severity of early (30 days after randomization) and late fistula-related complications (over 30 days after randomization), 30-day and 6-month postrandomization mortality rate, nutritional status at day 30, day 60, day 90 and day 180 postrandomization, the mean length of hospital stay, the patient's health-related quality of life (by self-assessment questionnaire), oral feeding time and direct costs of treatment. A total of 321 patients will be enrolled. DISCUSSION: The two nutritional supports are already used in daily practice, but most surgeons are reluctant to use the enteral route in case of PUGIF. This study will be the first randomized trial testing the role of EN versus TPN in PUGIF. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03742752. Registered on 14 November 2018.This research program is funded by the French Ministry of Health through Programme Hospitalier de Recherche Clinique 2016

Lithiases rénales et patients porteurs de grêle court et nutrition parentérale à domicile (étude à propos de 27 cas)

LYON1-BU Santé (693882101) / SudocPARIS-BIUM (751062103) / SudocSudocFranceF

Stress oxydant chez des patients en nutrition parentérale au long cours (rôle de l'émulsion lipidique)

LYON1-BU Santé (693882101) / SudocSudocFranceF

Statut en fluor et nutrition parentérale à domicile

LYON1-BU Santé (693882101) / SudocPARIS-BIUM (751062103) / SudocSudocFranceF

Prise en charge de grévistes de la faim lors du jeûne et de la renutrition (à partir de 19 cas)

LYON1-BU Santé (693882101) / SudocPARIS-BIUM (751062103) / SudocSudocFranceF

La Nutrition entérale à domicile

LYON1-BU Santé (693882101) / SudocSudocFranceF

L'absorption intestinale des vitamines hydrosolubles et liposolubles en pratique clinique

International audiencePoor vitamin intake, diminished intestinal absorption or metabolism alteration can all contribute to vitamin deficiencies. Over the last twenty years, advances in molecular biology have helped to identify the majority of intestinal vitamin transporters. The purpose of this review was to summarise the state of the art in this field to help the clinicians to recognise potential clinical risk situations related to alteration of vitamin absorption. Firstly, this review detailed the intestinal absorption site and the related transporter for each vitamin. Secondly, it reported the main factors able to alter vitamin absorption. Actually, different factors, such as drugs, alcohol or intestinal resection and gastrointestinal disorders modulate vitamin absorption. Water-soluble vitamins are mainly impacted by a competitive mechanism for their transport. Fat-soluble vitamin absorption is highly dependent on the lipid absorption, and, thus, gastrointestinal disorders inducing steatorrhea are at risk of fat-soluble vitamin deficiencies. Some of the knowledge in this field was provided by in vitro studies. Future studies on the current topic are required to transpose these studies in clinical practice. We highlighted gaps in the vitamin absorption field to suggest future research directions. (C) 2017 Association pour le developpement de la recherche en nutrition (ADREN). Published by Elsevier Masson SAS. All rights reserved

Dépistage de la dénutrition des personnes âgées de plus de 70 ans en ambulatoire. Étude auprès des médecins généralistes en Rhône-Alpes

International audienceContexte : La dénutrition protéinoénergétique chez la personne âgée (PA) est un problème de santé publique : 4% des personnes âgées vivant à domicile sont dénutries, 10% des personnes de plus de 80 ans. Un sujet âgé dénutri est plus fragile donc plus susceptible de présenter des pathologies en cascade. Le statut nutritionnel est un facteur prépondérant de morbi-mortalité. Objectif de l'étude : Réaliser une enquête de pratique des médecins généralistes de la région Rhône-Alpes devant le bilan nutritionnel spécifique d'une personne âgée, évaluer leurs connaissances théoriques ainsi que les modalités de prise en charge, en nous appuyant sur les dernières recommandations de la HAS (Haute Autorité de Santé). Méthode : Etude quantitative descriptive, par questionnaire anonyme auprès des médecins généralistes de la région Rhône-Alpes, de novembre 2010 à mars 2011. Résultats : 718 questionnaires envoyés, 186 réponses obtenues (26%). La majorité des médecins interrogés suit les recommandations pour le poids et l'IMC, mais 59% ne connaissent pas le MNA (Mini Nutritional Assessment). Soixante quatre pour cent des médecins interrogés réalisent un bilan nutritionnel dans l'année, 84% éduquent les patients et leur entourage, 86% prescrivent des compléments nutritionnels oraux, 88% jugent l'état nutritionnel important pour assurer un bon état de santé. Discussion : Notre travail met en évidence que la majorité des médecins utilise les recommandations de la HAS, même si les connaissances théoriques sont insuffisantes. Le poids reste un marqueur clinique important, à associer avec le calcul de l'IMC et la mesure de l'albuminémie. Les mesures anthropométriques sont très peu utilisées, mais semblent fiables pour déterminer une amyotrophie. Le MNA est très peu connu, non utilisé en ambulatoire, pourtant les données de la littérature sont en faveur de son utilisation comme outil de dépistage simple et fiable. Conclusion : Le médecin généraliste apparaît un acteur important du dépistage de la dénutrition. La majorité des médecins interrogés suit les recommandations de la HAS pour le dépistage, réalisant au moins un fois par an un bilan nutritionnel. Néanmoins, le dépistage pourrait être amélioré par une meilleure connaissance de la dénutrition et par l'utilisation d'outil simple comme le MNA