Effects of Bolus and Continuous Nasogastric Feeding on Small Bowel Water Content and Blood Flow
Condition: Enteral Feeding; Nasogastric Feeding; Diarrhoea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Following surgery some patients are unable to swallow. For those requiring nutritional
      support a tube is sometimes passed through the nose into the stomach to provide feeding.
      Traditionally this type of feeding is given slowly over the course of the day. However, it is
      thought that this mode of feeding might increase the amount of fluid entering the bowel
      contributing to symptoms of diarrhoea. An alternative strategy of feeding, given in larger
      volumes in a shorter space of time resembles normal feeding patterns and may reduce the
      amount of water entering the bowel.

      In this study we want to use a non invasive medical imaging technique called "magnetic
      resonance imaging" (or MRI) to look at the volume of bowel water following these two feeding
      strategies in 12 healthy volunteers.

      Each volunteer will have a tube inserted into the stomach via the nose and undergo the two
      feeding strategies at least 7 days apart. We will take repeated images using the MRI scanner
      to assess the bowel response and some samples of blood are required for analysis of blood
      sugar.
    

Detailed description: 
      1. Background. Nutritional support is often required for undernourished patients who are
           unable to meet daily nutritional requirements. This is often due to lack of
           consciousness or problems with swallowing, Nasogastric (NG) feeding is often employed to
           provide active enteric nutritional support. The current approach for delivering this
           support usually involves pump-assisted continuous feeding spread throughout the course
           of a day. However, this practice is far from physiological and may promote excessive
           secretion of fluid into the small bowel, contributing to gastrointestinal symptoms
           frequently experienced by NG fed patients. Rarely, continuous enteral tube feeding has
           been associated with small bowel ischaemia or necrosis, although this observation has
           almost always been made in the critically ill. Bolus feeds given in larger volumes over
           shorter time periods replicate the pattern of normal feeding. Consequently gastric
           emptying using this method is slowed and may, therefore, reduce the metabolic demand on
           the small intestine and prevent excessive accumulation of small bowel fluid.

        2. Aims. This study aims to investigate the influence of bolus or continuous NG feeding on
           small bowel fluid content and superior mesenteric blood flow. Our hypothesis is that
           bolus NG feeding results in lower small bowel fluid secretion and a reduction in
           superior mesenteric artery blood flow in comparison to individuals who are bolus NG fed.

        3. Experimental protocol and methods.

           This is a single-centre, cross-over study involving 12 healthy volunteers. Two studies
           will be undertaken for each volunteer approximately 7 days apart:

             -  Tube bolus (TB): feed administered via the NG tube over 5 min.

             -  Continuous tube drip feeding (TD): feed pump delivered via the NG tube over 4 h.

           The sequence of treatment allocations will be concealed to assessors until all
           interventions, data collection, and statistical analysis has been completed.

           Subjects will be asked to arrive at 8:30 a.m. at the Sir Peter Mansfield Magnetic
           Resonance 1.5T, University of Nottingham, having abstained from alcohol,
           caffeine-containing drinks, and any medication for at least 24 h prior to the study, as
           well as having fasted overnight. An 80 cm 8FR Freka (Fresenius Kabi, Runcorn, UK) fine
           bore nasogastric (NG) tube will be inserted into the stomach via the nose as well as a
           cannula in the ante cubital fossa for blood sampling. The position of the NG tube will
           be verified by magnetic resonance imaging (MRI). Once the tube is sited, the volunteer
           will be asked to sit for 5 min in order to allow the tubes to settle and the body adapt
           to their presence. Following NG intubation subjects will undergo baseline MRI scanning
           and blood sampling for glucose, insulin and PYY. Feeding will commence at time 0.
           Scanning and blood tests will proceed at 30 min intervals for a total of 4 h. The feed
           used in all studies will be 400 ml of Resource® Energy Vanilla nutrient drink (Nestle
           Nutrition, Société des Produits Nestlé S.A), which is typical of a standard oral
           supplement.

           In the TB study arm the supplement will be administered through the NG tube via syringes
           over 5 min; and in the TD study the feed will be administered using a pump at a rate of
           100 ml/h for 4 h.

        4. Measurable end points/statistical power of the study. Primary endpoint: Small bowel
           water content (SBWC). Secondary endpoints: Superior mesenteric artery blood flow,
           gastric content emptying time, plasma concentrations of glucose, insulin and peptide YY
           (PYY). Previous work using mannitol and glucose indicates that mean (SD) SBWC at 40
           minutes postprandially after ingesting 300ml glucose was 47 (SD 15) and using n=10 we
           calculate we can detect a difference of 17 ml (36%) between interventions with 90%
           power. We plan to recruit 12 to allow for dropouts.
    

Intervention name(s): NG bolus feeding over 5 min; Continuous NG feeding over 4 h
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Tube bolus (TB): 400 ml of Resource® Energy Vanilla nutrient drink, Societe des Produits Nestle S.A., administered via the NG tube over 5 min.; Continuous tube drip feeding (TD): 400 ml of Resource® Energy Vanilla nutrient drink, Societe des Produits Nestle S.A., delivered via feeding pump through the NG tube over 4 h.
Other intervention name(s): Resource® Energy Vanilla nutrient drink, Societe des Produits Nestle S.A; Resource® Energy Vanilla nutrient drink, Societe des Produits Nestle S.A
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Nasogastric; Small bowel water; Diarrhoea; Mesenteric blood flow; Enteral feeding