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Six-month outcomes of teduglutide treatment in adult patients with short bowel syndrome with chronic intestinal failure: A real-world French observational cohort study.
Joly, F, Seguy, D, Nuzzo, A, Chambrier, C, Beau, P, Poullenot, F, Thibault, R, Armengol Debeir, L, Layec, S, Boehm, V, et al
Clinical nutrition (Edinburgh, Scotland). 2020;(9):2856-2862
Abstract
BACKGROUND & AIMS Teduglutide, a GLP-2-analog, has proven effective in two placebo-controlled studies in reducing parenteral support (PS) in patients with short bowel syndrome-associated intestinal failure (SBS-IF) after 24 weeks. The aim of this study was to describe in a real-life situation the effects of teduglutide treatment and their predictive factors. METHODS We included 54 consecutive SBS-IF patients treated with teduglutide in France for at least 6 months from 10 expert centers. Small bowel length was 62 ± 6 cm and 65% had colon in continuity. PS was 4.4 ±0 .2 infusions per week, started 9.8 ± 1.2 years before. Response (PS reduction ≥ 20%) and PS discontinuation rates were assessed at week 24. Adjusted p values of factors associated with response and weaning were calculated using a multivariate logistic regression model. RESULTS At week 24, 85% of patients were responders and 24% had been weaned off PS, with a 51% reduction of PS needs and 1.5 ± 0.2 days off PS per week. Response to teduglutide was influenced by a higher baseline oral intake (p = 0.02). Weaning off PS was influenced by the presence of colon (p = 0.04), a lower PS volume (p = 0.03) and a higher oral intake (p = 0.01). There were no differences based on age, bowel length or SBS-IF causes. CONCLUSIONS Our study confirms the effectiveness of teduglutide in reducing PS needs in SBS-IF patients. We associated reduced parenteral support volume with baseline parenteral volume support, bowel anatomy, and oral intake. These findings underline the role of nutritional optimization when starting the treatment.
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Needs-based quality of life in adults dependent on home parenteral nutrition.
Burden, ST, Jones, DJ, Gittins, M, Ablett, J, Taylor, M, Mountford, C, Tyrrell-Price, J, Donnellan, C, Leslie, F, Bowling, T, et al
Clinical nutrition (Edinburgh, Scotland). 2019;(3):1433-1438
Abstract
BACKGROUND & AIMS Home parenteral nutrition (HPN) provides life sustaining treatment for people with chronic intestinal failure. Individuals may require HPN for months or years and are dependent on regular intravenous infusions, usually 12-14 h overnight between 1 and 7 days each week. This regime can have adverse impact on the life of people dependent on the treatment. The aim of this study was to establish mean values for the Parenteral Nutrition Impact Questionnaire (PNIQ) and to determine the effect of disease, frequency of infusions per week and patient characteristics on quality of life of patients fed HPN. METHOD The PNIQ was distributed to patients across nine UK HPN clinics. Data were analysed using linear regression, with PNIQ score as the dependent variable and potential confounders as independent variables. Unadjusted and adjusted models are presented. Higher PNIQ scores reflect poorer quality of life. RESULTS Completed questionnaires were received from 466 people dependent on HPN. Mean PNIQ score was 11.04 (SD 5.79). A higher PNIQ score (effect size 0.52, CI 0.184 to 0.853) was recorded in those dependent on a higher frequency of HPN infusions per week. Respondents with cancer had a similar mean PNIQ score to those with inflammatory bowel disease (mean 10.82, SD 6.00 versus 11.04, SD 5.91). Those with surgical complications reported a poorer QoL (effect size 3.03, CI 0.642 to 5.418) and those with severe gastro-intestinal dysmotility reported a better QoL (effect size -3.03, CI -5.593 to -0.468), compared to other disease states. CONCLUSIONS This large cohort study of quality of life in chronic intestinal failure demonstrates that HPN impacts individuals differently depending on their underlying disease. Furthermore, since the number of HPN infusions required per week is inversely related to an individual's needs-based quality of life, therapies that reduce PN burden should lead to an improvement in QoL.
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Chyme reinfusion in patients with intestinal failure due to temporary double enterostomy: A 15-year prospective cohort in a referral centre.
Picot, D, Layec, S, Dussaulx, L, Trivin, F, Thibault, R
Clinical nutrition (Edinburgh, Scotland). 2017;(2):593-600
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Abstract
BACKGROUND & AIMS Patients with double temporary enterostomy may suffer from intestinal failure (IF). Parenteral nutrition (PN) is the gold standard treatment until surgical reestablishment of intestinal continuity. Chyme reinfusion (CR) is a technique consisting in an extracorporeal circulation of the chyme. The aims were to determine: i) whether CR could restore intestinal absorption, decrease PN needs, improve nutritional status and plasma liver tests; ii) the feasibility of home CR. METHODS From the 232 patients IF consecutively referred for CR from 2000 to 2014, the 212 patients with IF, technical feasibility of CR, and effectively treated by CR, were included. Were collected prospectively before and during CR: daily stomal and fecal outputs, coefficients of nitrogen (CNDA) and fat (CFDA) digestive absorption, weight loss, body mass index (BMI), Nutritional Risk Index (NRI), plasma albumin, citrulline, and liver tests. RESULTS 183 patients had temporary double enterostomy and 29 exposed enterocutaneous fistulas. CR reduced the intestinal output (2444 ± 933 vs 370 ± 457 ml/day, P < 0.001), improved CNDA (46 ± 16 vs 80 ± 14%, P < 0.001) and CFDA (48 ± 25 vs 86 ± 11%, P < 0.001), and normalized plasma citrulline concentration (17.6 ± 8.4 vs 30.3 ± 11.8 μmol/l, P < 0.001). PN was stopped in 126/139 (91%) patients within 2 ± 8 d. Nutritional status improved (P < 0.001): weight (+4.6 ± 8.6%), BMI (+3.8 ± 7.7%), plasma albumin (+6.2 ± 6.1 g/l), and NRI (+10.9 ± 9.5). The proportion of patients with plasma liver tests abnormalities decreased (88 vs 51%, P < 0.01). Home CR was feasible without any serious complications in selected patients. CONCLUSIONS CR corrected the intestinal failure by restoring intestinal absorption, allowing PN weaning in 91% of patients. CR contributes to improve nutritional status and to reduce plasma liver tests abnormalities, and is feasible at home.
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The Leuven Immunomodulatory Protocol Promotes T-Regulatory Cells and Substantially Prolongs Survival After First Intestinal Transplantation.
Ceulemans, LJ, Braza, F, Monbaliu, D, Jochmans, I, De Hertogh, G, Du Plessis, J, Emonds, MP, Kitade, H, Kawai, M, Li, Y, et al
American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons. 2016;(10):2973-2985
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Intestinal transplantation (ITx) remains challenged by frequent/severe rejections and immunosuppression-related complications (infections/malignancies/drug toxicity). We developed the Leuven Immunomodulatory Protocol (LIP) in the lab and translated it to the clinics. LIP consists of experimentally proven maneuvers, destined to promote T-regulatory (Tregs)-dependent graft-protective mechanisms: donor-specific blood transfusion (DSBT); avoiding high-dose steroids/calcineurin-inhibitors; and minimizing reperfusion injury and endotoxin translocation. LIP was tested in 13 consecutive ITx from deceased donors (2000-2014) (observational cohort study). Recipient age was 37 years (2.8-57 years). Five-year graft/patient survival was 92%. One patient died at 9 months due to aspergillosis, another at 12 years due to nonsteroidal anti-inflammatory drug-induced enteropathy. Early acute rejection (AR) developed in two (15%); late AR in three (23%); all were reversible. No chronic rejection (CR) occurred. No malignancies developed and estimated glomerular filtration rate remained stable post-Tx. At last follow-up (3.5 years [0.5-12.5 years]), no donor-specific antibodies were detected and 11 survivors were total parenteral nutrition free with a Karnofsky score >90% in 8 recipients (follow-up >1 years). A high frequency of circulating CD4+ CD45RA- Foxp3hi memory Tregs was found (1.8% [1.39-2.21]), comparable to tolerant kidney transplant (KTx) recipients and superior to stable immunosuppression (IS)-KTx, KTx with CR, and healthy volunteers. In this ITx cohort we show that DSBT in a low-inflammatory/pro-regulatory environment activates Tregs at levels similar to tolerant-KTx, without causing sensitization. LIP limits rejection under reduced IS and thereby prolongs long-term survival to an extent not previously attained after ITx.
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Comparison of complications associated with peripherally inserted central catheters and Hickman™ catheters in patients with intestinal failure receiving home parenteral nutrition. Six-year follow up study.
Christensen, LD, Holst, M, Bech, LF, Drustrup, L, Nygaard, L, Skallerup, A, Rasmussen, HH, Vinter-Jensen, L
Clinical nutrition (Edinburgh, Scotland). 2016;(4):912-7
Abstract
BACKGROUND & AIM: Patients with intestinal failure (IF) are dependent on parenteral nutrition delivered through central access such as Hickman™ catheters. The peripherally inserted central catheter (PICC) is becoming increasingly popular for the purpose. The aim of the present study was to compare complication rates between the two types of catheters. PATIENTS AND METHODS Over a six-year period (2008-2014), we included 136 patients with IF receiving home parenteral nutrition (HPN). These patients had a total of 295 catheters (169 Hickman™ catheters and 126 PICCs). Data were collected by reviewing their medical records. Incidences are given per 1000 catheter days. Data are given as means ± standard deviation (SD) and compared using independent student's t-tests, Mann-Whitney-Wilcoxon, and X(2)-tests. A survival analysis for time to the first infection was conducted using Cox regression. RESULTS The total number of catheter days was 54,912 days for Hickman™ catheters (mean dwell time 325 ± 402) and 15,974 days for PICCs (mean dwell time 127 ± 121), respectively. The incidence of catheter-related blood stream infection (CRBSI) per 1000 catheter days was significantly lower for Hickman™ catheters compared to PICCs (0.56 vs. 1.63, p < 0.05). The mean time to first CRBSI was significantly shorter for PICCs compared to Hickman™ catheters (84 ± 94 days vs. 297 ± 387 days, p < 0.05), which was confirmed with a cox analysis corrected for age and gender. A total of 75 catheters were removed due to CRBSI, 49 Hickman™ catheters and 26 PICCs respectively. In addition, PICCs were more often removed due to local infection/phlebitis and mechanical causes (p < 0.001). CONCLUSION We found a higher risk and shorter time to first CRBSI in PICCs compared to Hickman catheters supporting that PICCs should mainly be chosen for planned HPN up to 3-6 months. We therefore conclude that the choice of catheter must still be determined on an individual basis.
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Limited long-term survival after in-hospital intestinal failure requiring total parenteral nutrition.
Oterdoom, LH, Ten Dam, SM, de Groot, SD, Arjaans, W, van Bodegraven, AA
The American journal of clinical nutrition. 2014;(4):1102-7
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BACKGROUND Total parenteral nutrition (TPN) is an invasive and advanced rescue feeding technique that has acceptable short-term survival although at costs of substantial risks. Survival after the clinical use of TPN >6 mo is unknown. OBJECTIVE We determined long-term survival after clinical TPN use in a consecutive cohort who were attending an academic hospital. DESIGN The study included a prospective cohort with a retrospective analysis of all 537 consecutive episodes of TPN in 437 patients between January 2010 and April 2012. Follow-up was until October 2013 with a total follow-up of 608 patient-years. Survival was analyzed by using Kaplan-Meier and Cox regression. RESULTS Survival was 58% in 437 patients with a first-time use of TPN at an average of 1.5 y after the initiation of TPN. The mortality rate was 30 deaths/100 patient-years. Older age, admission at an intensive care unit or a nonsurgical department, lower body mass index, and an underlying malignancy were positively associated with mortality. CONCLUSION TPN use, if correctly indicated, is a clinical sign of intestinal failure and a surrogate marker for markedly increased risk of mortality even >1.5 y after TPN use. This trial was registered at clinicaltrials.gov as NCT02189993 with protocol identification name TPN-01.
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Risk of low bone mineral density and low body mass index in patients with non-celiac wheat-sensitivity: a prospective observation study.
Carroccio, A, Soresi, M, D'Alcamo, A, Sciumè, C, Iacono, G, Geraci, G, Brusca, I, Seidita, A, Adragna, F, Carta, M, et al
BMC medicine. 2014;:230
Abstract
BACKGROUND Non-celiac gluten sensitivity (NCGS) or 'wheat sensitivity' (NCWS) is included in the spectrum of gluten-related disorders. No data are available on the prevalence of low bone mass density (BMD) in NCWS. Our study aims to evaluate the prevalence of low BMD in NCWS patients and search for correlations with other clinical characteristics. METHODS This prospective observation study included 75 NCWS patients (63 women; median age 36 years) with irritable bowel syndrome (IBS)-like symptoms, 65 IBS and 50 celiac controls. Patients were recruited at two Internal Medicine Departments. Elimination diet and double-blind placebo controlled (DBPC) wheat challenge proved the NCWS diagnosis. All subjects underwent BMD assessment by Dual Energy X-Ray Absorptiometry (DXA), duodenal histology, HLA DQ typing, body mass index (BMI) evaluation and assessment for daily calcium intake. RESULTS DBPC cow's milk proteins challenge showed that 30 of the 75 NCWS patients suffered from multiple food sensitivity. Osteopenia and osteoporosis frequency increased from IBS to NCWS and to celiac disease (CD) (P <0.0001). Thirty-five NCWS patients (46.6%) showed osteopenia or osteoporosis. Low BMD was related to low BMI and multiple food sensitivity. Values of daily dietary calcium intake in NCWS patients were significantly lower than in IBS controls. CONCLUSIONS An elevated frequency of bone mass loss in NCWS patients was found; this was related to low BMI and was more frequent in patients with NCWS associated with other food sensitivity. A low daily intake of dietary calcium was observed in patients with NCWS.
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[Short bowel syndrome and failure intestinal features in our community].
Salazar Quero, JC, Blasco Alonso, J, Pérez Parras, A, Rivero de la Rosa, MC, Gilbert Pérez, JJ, Blanca García, JA, Espín Jaime, B
Nutricion hospitalaria. 2014;(3):1109-15
Abstract
INTRODUCTION Intestinal failure is being an entity with higher prevalence in the pediatric age, especially due to bowel resections causing the appearance of a short bowel syndrome. OBJECTIVES To determine the prevalence and etiology of cases of short bowel syndrome (SIC) and Intestinal Failure (FI) existing in Andalusia. Analyze factors involved in evolution, the number of transplant patients and to know the time required to achieve enteral autonomy, studying whether there are differences in management between different participants. METHODS Multicenter retrospective descriptive observational study in which are collected data of patients diagnosed with short bowel syndrome or intestinal failure in 6 hospitals in Andalusia in the period from 1 January 2008 to 31 January 2014. RESULTS 25 patients. Average age at diagnosis 7.4 months. Average length of remnant intestine: 113.8 cm; 64% of patients with <75 cm length remaining intestine. We show that: the early introduction of enteral nutrition is a factor favoring the suspension of the NP (p = 0'033); and that the prevention of liver disease associated with parenteral nutrition (EHANP) is favored by: the use of fewer lipid Parenteral Nutrition (p = 0'008), a greater length of remaining intestine (p = 0'049 ), the early introduction of enteral nutrition (p = 0'009) and a lower gestational age (p = 0'006).