Effects of Bolus and Continuous Nasogastric Feeding on Small Bowel Water Content and Blood Flow

Diarrhoea Clinical Trial

Official title:

Effects of Bolus and Continuous Nasogastric Feeding on Small Bowel Water Content and Blood Flow

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01557673
• Other study ID #: H062011
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 12, 2012
• Last updated: May 3, 2013
• Start date: January 2012
• Est. completion date: December 2012

Study information

• Verified date: May 2013
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy

• Male

• Able to undergo safe magnetic resonance scanning

Exclusion Criteria:

• Female

• Chronic medical conditions

• Regular medication

• Unable to undergo safe magentic resonance scanning

• Previous abdominal surgery

• Smoking

Study Design

Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diarrhoea
• Enteral Feeding
• Nasogastric Feeding

Intervention

Dietary Supplement:
• NG bolus feeding over 5 min
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 NG feeding over 4 h
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.

Locations

Country	Name	City	State
United Kingdom	Sir Peter Mansfield Magnetic Resonance Centre	Nottingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

References & Publications (9)

Dempsey DT, Mullen JL, Buzby GP. The link between nutritional status and clinical outcome: can nutritional intervention modify it? Am J Clin Nutr. 1988 Feb;47(2 Suppl):352-6. Review. — View Citation

Hoad CL, Marciani L, Foley S, Totman JJ, Wright J, Bush D, Cox EF, Campbell E, Spiller RC, Gowland PA. Non-invasive quantification of small bowel water content by MRI: a validation study. Phys Med Biol. 2007 Dec 7;52(23):6909-22. Epub 2007 Nov 8. — View Citation

Keohane PP, Attrill H, Love M, Frost P, Silk DB. Relation between osmolality of diet and gastrointestinal side effects in enteral nutrition. Br Med J (Clin Res Ed). 1984 Mar 3;288(6418):678-80. — View Citation

Kocan MJ, Hickisch SM. A comparison of continuous and intermittent enteral nutrition in NICU patients. J Neurosci Nurs. 1986 Dec;18(6):333-7. — View Citation

Lobo DN, Hendry PO, Rodrigues G, Marciani L, Totman JJ, Wright JW, Preston T, Gowland P, Spiller RC, Fearon KC. Gastric emptying of three liquid oral preoperative metabolic preconditioning regimens measured by magnetic resonance imaging in healthy adult volunteers: a randomised double-blind, crossover study. Clin Nutr. 2009 Dec;28(6):636-41. doi: 10.1016/j.clnu.2009.05.002. Epub 2009 Jun 4. — View Citation

Marciani L, Cox EF, Hoad CL, Pritchard S, Totman JJ, Foley S, Mistry A, Evans S, Gowland PA, Spiller RC. Postprandial changes in small bowel water content in healthy subjects and patients with irritable bowel syndrome. Gastroenterology. 2010 Feb;138(2):469-77, 477.e1. doi: 10.1053/j.gastro.2009.10.055. Epub 2009 Nov 10. — View Citation

Melis M, Fichera A, Ferguson MK. Bowel necrosis associated with early jejunal tube feeding: A complication of postoperative enteral nutrition. Arch Surg. 2006 Jul;141(7):701-4. — View Citation

Sarap AN, Sarap MD, Childers J. Small bowel necrosis in association with jejunal tube feeding. JAAPA. 2010 Nov;23(11):28, 30-2. — View Citation

Stroud M, Duncan H, Nightingale J; British Society of Gastroenterology. Guidelines for enteral feeding in adult hospital patients. Gut. 2003 Dec;52 Suppl 7:vii1-vii12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Small bowel water volume (ml)	Small bowel water content assessed by magnetic resonance imaging.	0-240 min	No
Secondary	Gastric emptying	Gastric volume assessed by magnetic resonance imaging.	0-240 min	No
Secondary	Superior mesenteric artery blood flow	Superior mesenteric artery blood flow and velocity assessed by magnetic resonance imaging.	0-240 min	No
Secondary	Peptide YY	Serum concentration of peptide YY	0-240 min	No
Secondary	Insulin	Serum concentration of insulin	0-240 min	No
Secondary	Glucose	Serum concentration of glucose	0-240 min	No