PI013012-20 | Buongiorno
Spettabile Ente,
in riferimento alla procedura siamo con la presente a rilevare quanto segue:
LOTTO 12 e LOTTO 13
Si chiede di rettificare la descrizione del lotto, eliminando dalla descrizione la richiesta di MCT. Si fa presente che il prodotto attualmente in uso presso i presidi è senza MCT.
Peraltro relativamente alla presenza di MCT in diete standard si fa notare quanto segue:
La presenza di MCT in diete cosiddette standard non ha evidenza nella letteratura scientifica. Dalla letteratura scientifica disponibile emerge che i risultati più promettenti relativamente all’utilizzo degli MCT nelle diete formula si riferiscono al trattamento di pazienti con condizioni patologiche specifiche. Si allega un elenco degli studi più significativi con l’evidenza dei risultati clinici.
7) Bernini et al. investigated the possible use of MCT enriched enteral nutrition in patients that underwent to traumatic brain damage (TBI). The authors of the study, indeed, wanted to verify if the continuous enteral feeding with MCT could improve ketogenic metabolism, protective factor for neuro-induced damages. 34 patients enrolled for the study were monitored with cerebral micro- dialysis in order to measure total brain interstitial and circulating levels of ketonic bodies and free fatty acids. However, measurements did not indicate an increase in blood KB, just a modest increase in blood and brain free medium chain fatty acids. Ketogenic metabolism in this case seems not influenced by MCT supplementation.
8) Another specific application of MCT enriched nutrition has involved patients with anorexia nervosa. The aim of Kawai et al was to investigate if MCT rich nutrition could influence ghrelin and Neuropeptide Y levels in anorexic patients. Ghrelin is a peptide found in the stomach that increases appetite and fat-free mass while suppressing energy expenditure, its active form requires a structural modification by MCT, necessary passage to exert its physiological action. That’s why the authors hypothesized that an increased availability on MCT substrates could increase the levels of active ghreline and other related mediators (neuropeptide Y). The results of the small study (30 patients) showed higher levels of activated ghrelin in patients exposed to high doses of MCT.
9) Chyle leaks and abscesses are complications that could occur after abdominal surgery procedures (e.g. major pancreatic resection) that consists in the pathologic leakage of triglycerides rich lymphatic fluids into peritoneal cavity. To find the most appropriate nutritional support in these kind of complicated patients, Pan et al conducted a retrospective study that examined the nutritional management of 58 patients that incurred in this complication after abdominal surgery. The therapeutic protocol was associated to oral MCT supplementation, total parenteral nutrition and MCT+EN nutrition. Parameters such as tube time removal, time to resumption of an oral diet, length of hospital stay were better when the treatment with somatostatin were associated to TPN and MCT+EN regime. The article however gets EN+MCT as better option since the plan has a better cost effectiveness ratio.
10) The tolerability of enriched MCT EN formulas were investigated by Hilal et al on patients that underwent to major pancreatic resection and developed chyle leaks complications. The treated patients didn’t show additional morbidity or mortality, compared to the control group (parenteral nutrition) following the implementation of MCT regimen, so the author concluded that this formulas are safe.
11) Jakob et al started from the evidence that one of the most common symptoms in intensive care units is diarrhea and that it is associated to discomfort and complications that could increase length of stay and nursing workload. The prospective double-blind study compared the incidence of diarrhea episodes in two group of patients respectively under a MCT and fish oil enriched formula against a standard diet. However, no clinical benefit was verified with the treatment group.
Bibliografia a supporto
7) Modulation of cerebral ketone metabolism following traumatic brain injury in humans. Bernini, Adriano, et al. 24 10 2018, Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism, p. 271678X18808947. promettente per MCT per matabolismo corpi chetonici nel TBI . 10.1177/0271678X18808947.
8) Ghrelin activation and neuropeptide Y elevation in response to medium chain triglyceride administration in anorexia nervosa patients. Kawai, Keisuke, et al. 2 2017, Clinical nutrition ESPEN, Vol. 17, p. 100-104. 10.1016/j.clnesp.2016.10.001.
9) The application of nutrition support in conservative treatment of chylous ascites after abdominal surgery. Pan, Wu, et al. 4 2016, Therapeutics and clinical risk management, Vol. 12, p. 607-12. positivo leakage studio un po strano. 10.2147/TCRM.S100266.
10)Postoperative chyle leak after major pancreatic resections in patients who receive enteral feed: risk factors and management options. Abu Hilal, Mohammed, et al. 12, 8 12 2013, World journal of surgery, Vol. 37, p. 2918-26. clinical study positivo per MCT in chyle leaks after pancreatic cose. 10.1007/s00268-013-2171-x.
11). A randomized controlled pilot study to evaluate the effect of an enteral formulation designed to improve gastrointestinal tolerance in the critically ill patient-the SPIRIT trial. Jakob, Stephan M, et al. 1, 10 12 2017, Critical care (London, England), Vol. 21, p. 140.
LOTTO 14
Si chiede di rettificare la descrizione del lotto, eliminando dalla descrizione la richiesta di MCT. Si fa notare alla Commissione valutativa quanto segue:
La presenza di MCT in diete cosiddette standard non ha evidenza nella letteratura scientifica. Dalla letteratura scientifica disponibile emerge che i risultati più promettenti relativamente all’utilizzo degli MCT nelle diete formula si riferiscono al trattamento di pazienti con condizioni patologiche specifiche. Si allega un elenco degli studi più significativi con l’evidenza dei risultati clinici.
7) Bernini et al. investigated the possible use of MCT enriched enteral nutrition in patients that underwent to traumatic brain damage (TBI). The authors of the study, indeed, wanted to verify if the continuous enteral feeding with MCT could improve ketogenic metabolism, protective factor for neuro-induced damages. 34 patients enrolled for the study were monitored with cerebral micro- dialysis in order to measure total brain interstitial and circulating levels of ketonic bodies and free fatty acids. However, measurements did not indicate an increase in blood KB, just a modest increase in blood and brain free medium chain fatty acids. Ketogenic metabolism in this case seems not influenced by MCT supplementation.
8) Another specific application of MCT enriched nutrition has involved patients with anorexia nervosa. The aim of Kawai et al was to investigate if MCT rich nutrition could influence ghrelin and Neuropeptide Y levels in anorexic patients. Ghrelin is a peptide found in the stomach that increases appetite and fat-free mass while suppressing energy expenditure, its active form requires a structural modification by MCT, necessary passage to exert its physiological action. That’s why the authors hypothesized that an increased availability on MCT substrates could increase the levels of active ghreline and other related mediators (neuropeptide Y). The results of the small study (30 patients) showed higher levels of activated ghrelin in patients exposed to high doses of MCT.
9) Chyle leaks and abscesses are complications that could occur after abdominal surgery procedures (e.g. major pancreatic resection) that consists in the pathologic leakage of triglycerides rich lymphatic fluids into peritoneal cavity. To find the most appropriate nutritional support in these kind of complicated patients, Pan et al conducted a retrospective study that examined the nutritional management of 58 patients that incurred in this complication after abdominal surgery. The therapeutic protocol was associated to oral MCT supplementation, total parenteral nutrition and MCT+EN nutrition. Parameters such as tube time removal, time to resumption of an oral diet, length of hospital stay were better when the treatment with somatostatin were associated to TPN and MCT+EN regime. The article however gets EN+MCT as better option since the plan has a better cost effectiveness ratio.
10) The tolerability of enriched MCT EN formulas were investigated by Hilal et al on patients that underwent to major pancreatic resection and developed chyle leaks complications. The treated patients didn’t show additional morbidity or mortality, compared to the control group (parenteral nutrition) following the implementation of MCT regimen, so the author concluded that this formulas are safe.
11) Jakob et al started from the evidence that one of the most common symptoms in intensive care units is diarrhea and that it is associated to discomfort and complications that could increase length of stay and nursing workload. The prospective double-blind study compared the incidence of diarrhea episodes in two group of patients respectively under a MCT and fish oil enriched formula against a standard diet. However, no clinical benefit was verified with the treatment group.
Bibliografia a supporto
7) Modulation of cerebral ketone metabolism following traumatic brain injury in humans. Bernini, Adriano, et al. 24 10 2018, Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism, p. 271678X18808947. promettente per MCT per matabolismo corpi chetonici nel TBI . 10.1177/0271678X18808947.
8) Ghrelin activation and neuropeptide Y elevation in response to medium chain triglyceride administration in anorexia nervosa patients. Kawai, Keisuke, et al. 2 2017, Clinical nutrition ESPEN, Vol. 17, p. 100-104. 10.1016/j.clnesp.2016.10.001.
9) The application of nutrition support in conservative treatment of chylous ascites after abdominal surgery. Pan, Wu, et al. 4 2016, Therapeutics and clinical risk management, Vol. 12, p. 607-12. positivo leakage studio un po strano. 10.2147/TCRM.S100266.
10)Postoperative chyle leak after major pancreatic resections in patients who receive enteral feed: risk factors and management options. Abu Hilal, Mohammed, et al. 12, 8 12 2013, World journal of surgery, Vol. 37, p. 2918-26. clinical study positivo per MCT in chyle leaks after pancreatic cose. 10.1007/s00268-013-2171-x.
11). A randomized controlled pilot study to evaluate the effect of an enteral formulation designed to improve gastrointestinal tolerance in the critically ill patient-the SPIRIT trial. Jakob, Stephan M, et al. 1, 10 12 2017, Critical care (London, England), Vol. 21, p. 140.
LOTTO 16
Si chiede di rettificare la descrizione del lotto, eliminando dalla descrizione la richiesta di MCT e si chiede di cambiare la richiesta di FOS in FOS o inulina.
Si fa notare alla Commissione valutativa quanto segue:
MCT:
La presenza di MCT in diete cosiddette standard non ha evidenza nella letteratura scientifica. Dalla letteratura scientifica disponibile emerge che i risultati più promettenti relativamente all’utilizzo degli MCT nelle diete formula si riferiscono al trattamento di pazienti con condizioni patologiche specifiche. Si allega un elenco degli studi più significativi con l’evidenza dei risultati clinici.
7) Bernini et al. investigated the possible use of MCT enriched enteral nutrition in patients that underwent to traumatic brain damage (TBI). The authors of the study, indeed, wanted to verify if the continuous enteral feeding with MCT could improve ketogenic metabolism, protective factor for neuro-induced damages. 34 patients enrolled for the study were monitored with cerebral micro- dialysis in order to measure total brain interstitial and circulating levels of ketonic bodies and free fatty acids. However, measurements did not indicate an increase in blood KB, just a modest increase in blood and brain free medium chain fatty acids. Ketogenic metabolism in this case seems not influenced by MCT supplementation.
8) Another specific application of MCT enriched nutrition has involved patients with anorexia nervosa. The aim of Kawai et al was to investigate if MCT rich nutrition could influence ghrelin and Neuropeptide Y levels in anorexic patients. Ghrelin is a peptide found in the stomach that increases appetite and fat-free mass while suppressing energy expenditure, its active form requires a structural modification by MCT, necessary passage to exert its physiological action. That’s why the authors hypothesized that an increased availability on MCT substrates could increase the levels of active ghreline and other related mediators (neuropeptide Y). The results of the small study (30 patients) showed higher levels of activated ghrelin in patients exposed to high doses of MCT.
9) Chyle leaks and abscesses are complications that could occur after abdominal surgery procedures (e.g. major pancreatic resection) that consists in the pathologic leakage of triglycerides rich lymphatic fluids into peritoneal cavity. To find the most appropriate nutritional support in these kind of complicated patients, Pan et al conducted a retrospective study that examined the nutritional management of 58 patients that incurred in this complication after abdominal surgery. The therapeutic protocol was associated to oral MCT supplementation, total parenteral nutrition and MCT+EN nutrition. Parameters such as tube time removal, time to resumption of an oral diet, length of hospital stay were better when the treatment with somatostatin were associated to TPN and MCT+EN regime. The article however gets EN+MCT as better option since the plan has a better cost effectiveness ratio.
10) The tolerability of enriched MCT EN formulas were investigated by Hilal et al on patients that underwent to major pancreatic resection and developed chyle leaks complications. The treated patients didn’t show additional morbidity or mortality, compared to the control group (parenteral nutrition) following the implementation of MCT regimen, so the author concluded that this formulas are safe.
11) Jakob et al started from the evidence that one of the most common symptoms in intensive care units is diarrhea and that it is associated to discomfort and complications that could increase length of stay and nursing workload. The prospective double-blind study compared the incidence of diarrhea episodes in two group of patients respectively under a MCT and fish oil enriched formula against a standard diet. However, no clinical benefit was verified with the treatment group.
Bibliografia a supporto
7) Modulation of cerebral ketone metabolism following traumatic brain injury in humans. Bernini, Adriano, et al. 24 10 2018, Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism, p. 271678X18808947. promettente per MCT per matabolismo corpi chetonici nel TBI . 10.1177/0271678X18808947.
8) Ghrelin activation and neuropeptide Y elevation in response to medium chain triglyceride administration in anorexia nervosa patients. Kawai, Keisuke, et al. 2 2017, Clinical nutrition ESPEN, Vol. 17, p. 100-104. 10.1016/j.clnesp.2016.10.001.
9) The application of nutrition support in conservative treatment of chylous ascites after abdominal surgery. Pan, Wu, et al. 4 2016, Therapeutics and clinical risk management, Vol. 12, p. 607-12. positivo leakage studio un po strano. 10.2147/TCRM.S100266.
10)Postoperative chyle leak after major pancreatic resections in patients who receive enteral feed: risk factors and management options. Abu Hilal, Mohammed, et al. 12, 8 12 2013, World journal of surgery, Vol. 37, p. 2918-26. clinical study positivo per MCT in chyle leaks after pancreatic cose. 10.1007/s00268-013-2171-x.
11). A randomized controlled pilot study to evaluate the effect of an enteral formulation designed to improve gastrointestinal tolerance in the critically ill patient-the SPIRIT trial. Jakob, Stephan M, et al. 1, 10 12 2017, Critical care (London, England), Vol. 21, p. 140.
FOS e Inulina
L’inulina è un fruttano polimero del fruttosio a catena lunga mentre il FOS è un polimero del fruttano a catena corta. L’inulina, al pari di FOS (Fruttoligosaccaridi a catena corta) è una fibra solubile fermentabile non viscosa. Gli effetti metabolici di inulina e FOS sono del tutto analoghi in setting di ricerca diversi. Inulina e FOS dimostrano analogo effetto prebiotico sul microbiota (effetto prebiotico, effetto di produzione di SCFA) ed effetto sinergico sulla regolarizzazione del transito intestinale con le fibre insolubili sono assolutamente analoghe e sovrapponibili, come l’ampia documentazione a corredo dimostra. Dalla letteratura disponibile non si evidenziano differenze di attività tra inulina e FOS, che possono quindi essere considerati del tutto sovrapponibili (bibliografia 1-6 a supporto)
1)Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). Journal of Parenteral and Enteral Nutrition Volume 40 Number 2 February 2016 159–211
2)Fermentation of Fructooligosaccharides and Inulin by Bifidobacteria: a Comparative Study of Pure and Fecal Cultures. Maddalena Rossi,* Claudio Corradini, Alberto Amaretti, Marcello Nicolini, Anna Pompei,
Simona Zanoni,3and Diego Matteuzzi . APPLIED AND ENVIRONMENTAL MICROBIOLOGY, Oct. 2005, p. 6150–6158 Vol. 71, No. 10
3)Introducing inulin-type fructans
Marcel B. Roberfroid . British Journal of Nutrition (2005), 93, Suppl. 1, S13–S25
4)Prebiotic inulin-type fructans induce specific changes in the human gut microbiota. Doris Vandeputte,1,2,3 Gwen Falony,1,2 Sara Vieira-Silva,1,2 Jun Wang,1,2 Manuela Sailer,4 Stephan Theis,4 Kristin Verbeke,5 Jeroen Raes1,2,3. Gut 2017;66:1968–1974.
5)Prebiotic inulin-type fructans and galacto-oligosaccharides: definition, specificity, function, and application in gastrointestinal disorders . Bridgette Wilson and Kevin Whelan . Journal of Gastroenterology and Hepatology 2017; 32 (Suppl. 1): 64–68
6)Fiber and prebiotic supplementation in enteral nutrition: a systematic review and meta-analysis
Mazuin Kamarul Zaman, Kin-Fah Chin, Vineya Rai, Hazreen Abdul Majid World J Gastroenterol 2015 May 7; 21(17): 5372-5381
Per le motivazioni sopra esposte, chiediamo di provvedere alla rettifica degli atti di gara, in autotutela, nelle parti evidenziate al fine di porre tutti i partecipanti in condizioni di reale concorrenza senza discriminazione alcuna ai sensi dell’art. 30 del D.lgs 50/16 Le specifiche tecniche richieste, devono consentire pari accesso degli operatori economici alla procedura di aggiudicazione e non devono comportare direttamente o indirettamente ostacoli ingiustificati alla concorrenza (art. 68 D.Lgs 50/16).
Attendiamo Vostro cortese riscontro entro 5 giorni, in caso contrario la scrivente si riserva di provvedere a tutelare i propri interessi presso le sedi competenti.
RingraziandoVi per ’attenzione ed in attesa di un Vostro cortese riscontro, cordialmente salutiamo
| Lotto 12 e 13 : attenersi al capitolato tecnico
Lotto 14: attenersi al capitolato tecnico
Lotto 16: attenersi al capitolato
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