Study protocol: Cost-effectiveness of transmural nutritional support in malnourished elderly patients in comparison with usual care

BACKGROUND: Malnutrition is a common consequence of disease in older patients. Both in hospital setting and in community setting oral nutritional support has proven to be effective. However, cost-effectiveness studies are scarce. Therefore, the aim of our study is to investigate the effectiveness and cost-effectiveness of transmural nutritional support in malnourished elderly patients, starting at hospital admission until three months after discharge. METHODS: This study is a randomized controlled trial. Patients are included at hospital admission and followed until three months after discharge. Patients are eligible to be included when they are > or = 60 years old and malnourished according to the following objective standards: Body Mass Index (BMI in kg/m2) < 20 and/or > or = 5% unintentional weight loss in the previous month and/or > or = 10% unintentional weight loss in the previous six months. We will compare usual nutritional care with transmural nutritional support (energy and protein enriched diet, two additional servings of an oral nutritional supplement, vitamin D and calcium supplementation, and consultations by a dietitian). Each study arm will consist of 100 patients. The primary outcome parameters will be changes in activities of daily living (determined as functional limitations and physical activity) between intervention and control group. Secondary outcomes will be changes in body weight, body composition, quality of life, and muscle strength. An economic evaluation from a societal perspective will be conducted alongside the randomised trial to evaluate the cost-effectiveness of the intervention in comparison with usual care. CONCLUSION: In this randomized controlled trial we will evaluate the effect of transmural nutritional support in malnourished elderly patients after hospital discharge, compared to usual care. Primary endpoints of the study are changes in activities of daily living, body weight, body composition, quality of life, and muscle strength. An economic evaluation will be performed to evaluate the cost-effectiveness of the intervention in comparison with usual care. TRIAL REGISTRATION: Netherlands Trial Register (ISRCTN29617677, registered 14-Sep-2005)

Prevention of malnutrition in older people during and after hospitalisation: results from a randomised controlled clinical trial

Objective: to prevent the occurrence of weight loss during hospitalisation and following discharge by daily oral supplementation. Design: in a prospective, randomised, controlled study of 80 patients aged 75 or more, and at risk of undernutrition based on their initial Mini Nutritional Assessment score, patients were randomised into a control group or one receiving oral supplementation. The intervention was a prescription of 200 ml sweet or salty sip feed twice daily (500 kcal, 21 g protein per day) throughout hospitalisation and convalescence. Nutritional status was assessed at baseline and after 2 months using Mini Nutritional Assessment and body weight record. Results: compliance with oral supplementation was good and daily extra energy intake was 407+/-184 kcal. On day 60, significant weight loss from upon admission was observed in the control group (-1.23+/-2.5 kg; P=0.01), but not in the supplemented group (0.28+/-3.8 kg; NS). At the end of the study, Mini Nutritional Assessment scores were higher in the supplemented group than in the control group (23.5+/-3.9 versus 20.8+/-3.6; P<0.01). Conclusion: use of daily oral supplementation during and after hospitalisation maintains body weight and increases Mini Nutritional Assessment score in patients at risk of undernutrition

Improvement in quality of life of children with acute Crohn's disease does not parallel mucosal healing after treatment with exclusive enteral nutrition

Crohn's disease is a chronic debilitating disorder affecting a child's physical and emotional well-being. Recent emphasis on 'quality of life' (QOL) has led to re-evaluation of available medical treatments. To assess prospectively change in QOL, clinical disease activity and intestinal mucosal inflammation in active paediatric Crohn's disease after treatment with exclusive enteral nutrition. In addition, we evaluated whether change in QOL could predict changes in paediatric Crohn's disease activity index (PCDAI) and mucosal inflammation (endoscopic and histologic). The IMPACT II questionnaire was used prospectively and longitudinally in 26 consecutively recruited children [16 males (67%), median 14 years, s.d. = 1.7 years] with active Crohn's disease (PCDAI > 20). They were treated with a new polymeric enteral feed (ACD004, Nestle) for a period of 8 weeks. All had PCDAI, QOL and endoscopic assessment at the time of diagnosis and after 8 weeks of treatment. Twenty-three of 26 children achieved a clinical remission at 8 weeks, with improvement in the QOL scores (P <0.05). The change in QOL score after treatment was predictive of achieving a clinical remission, but not of histological improvement. Although children may find dietary restrictions difficult, this study confirms a clear improvement in QOL after treatment with exclusive enteral nutrition. However, improvement in QOL scores is not reflected by improvement in mucosal inflammation. Whilst improving QOL remains a core principal in patient management, the long-term consequences of ongoing mucosal inflammation must be better understood before relying only on short-term QOL measures to dictate treatment choice

Antibody-dependent Cell-mediated Anti-bacterial Activity Of Intestinal Lymphocytes With Secretory Iga

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/62531/1/306184a0.pd

Immunohistochemical analysis of coeliac mucosa following ingestion of oats

There is now considerable clinical evidence that oats do not activate coeliac disease. Nonetheless, a reluctance to include oats in the gluten-free diet remains. Because gluten-induced damage is accompanied by activation of the gastrointestinal immune system, the purpose of this study was to investigate if similar changes were induced by oats ingestion. Small intestinal histological sections from 10 patients who ingested 50 g of oats daily for 3 months were investigated for possible evidence of immune activation. Tissue obtained before and after oats challenge was stained with a series of antibodies directed against the following molecules: human leucocyte antigen D-related (HLA-DR), Ki-67, CD25, CD54 [intercellular adhesion molecule 1 (ICAM-1)] and mast cell tryptase. None of the patients developed clinical or laboratory evidence of adverse effects. The distribution of intestinal HLA-DR expression was not affected by oats ingestion and the crypt epithelium remained unstained. In the pre-oats biopsies, the percentage of Ki-67 positive enterocytes, 29·5 ± 6·9 [95% confidence interval (CI) 13·9–45·0] did not differ significantly from that found in postoats biopsies, 41·2 ± 3·7 (95% CI, 32·8–49·6), P = 0·19, not significant. Furthermore, oats ingestion did not alter the number of CD25 positive and tryptase positive cells. Finally, the distribution and intensity of ICAM-1 staining was unchanged by dietary oats. In summary, detailed immunohistological studies of biopsies from patients ingesting oats for 3 months did not reveal evidence of immune activation. Together with other reported findings, this study strengthens the view that oats can be included safely in the diet of gluten sensitive patients