Effects of Bolus and Continuous Nasogastric Feeding on Small Bowel Water Content and Blood Flow
Primary Purpose
Enteral Feeding, Nasogastric Feeding, Diarrhoea
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
NG bolus feeding over 5 min
Continuous NG feeding over 4 h
Sponsored by
About this trial
This is an interventional basic science trial for Enteral Feeding focused on measuring Nasogastric, Small bowel water, Diarrhoea, Mesenteric blood flow, Enteral feeding
Eligibility Criteria
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
Sites / Locations
- Sir Peter Mansfield Magnetic Resonance Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
NG bolus feeding over 5 min
Continuous NG feeding over 4 h
Arm Description
Tube bolus (TB): feed administered via syringe through NG tube over 5 min.
Continuous tube drip feeding (TD): feed pump delivered via the NG tube over 4 h.
Outcomes
Primary Outcome Measures
Small bowel water volume (ml)
Small bowel water content assessed by magnetic resonance imaging.
Secondary Outcome Measures
Gastric emptying
Gastric volume assessed by magnetic resonance imaging.
Superior mesenteric artery blood flow
Superior mesenteric artery blood flow and velocity assessed by magnetic resonance imaging.
Peptide YY
Serum concentration of peptide YY
Insulin
Serum concentration of insulin
Glucose
Serum concentration of glucose
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01557673
Brief Title
Effects of Bolus and Continuous Nasogastric Feeding on Small Bowel Water Content and Blood Flow
Official Title
Effects of Bolus and Continuous Nasogastric Feeding on Small Bowel Water Content and Blood Flow
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
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.
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.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enteral Feeding, Nasogastric Feeding, Diarrhoea
Keywords
Nasogastric, Small bowel water, Diarrhoea, Mesenteric blood flow, Enteral feeding
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NG bolus feeding over 5 min
Arm Type
Active Comparator
Arm Description
Tube bolus (TB): feed administered via syringe through NG tube over 5 min.
Arm Title
Continuous NG feeding over 4 h
Arm Type
Placebo Comparator
Arm Description
Continuous tube drip feeding (TD): feed pump delivered via the NG tube over 4 h.
Intervention Type
Dietary Supplement
Intervention Name(s)
NG bolus feeding over 5 min
Other Intervention Name(s)
Resource® Energy Vanilla nutrient drink, Societe des Produits Nestle S.A
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Continuous NG feeding over 4 h
Other Intervention Name(s)
Resource® Energy Vanilla nutrient drink, Societe des Produits Nestle S.A
Intervention Description
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.
Primary Outcome Measure Information:
Title
Small bowel water volume (ml)
Description
Small bowel water content assessed by magnetic resonance imaging.
Time Frame
0-240 min
Secondary Outcome Measure Information:
Title
Gastric emptying
Description
Gastric volume assessed by magnetic resonance imaging.
Time Frame
0-240 min
Title
Superior mesenteric artery blood flow
Description
Superior mesenteric artery blood flow and velocity assessed by magnetic resonance imaging.
Time Frame
0-240 min
Title
Peptide YY
Description
Serum concentration of peptide YY
Time Frame
0-240 min
Title
Insulin
Description
Serum concentration of insulin
Time Frame
0-240 min
Title
Glucose
Description
Serum concentration of glucose
Time Frame
0-240 min
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abeed H Chowdhury, BSc MRCS
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tim Bowling, MD FRCP
Organizational Affiliation
Nottingham University Hospitals NHS Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Sir Peter Mansfield Magnetic Resonance Centre
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2RD
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
3124596
Citation
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Results Reference
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PubMed Identifier
14612488
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(Suppl 7):vii1-vii12. doi: 10.1136/gut.52.suppl_7.vii1. No abstract available.
Results Reference
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PubMed Identifier
6421429
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. doi: 10.1136/bmj.288.6418.678.
Results Reference
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PubMed Identifier
2949027
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. doi: 10.1097/01376517-198612000-00004.
Results Reference
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PubMed Identifier
21086887
Citation
Sarap AN, Sarap MD, Childers J. Small bowel necrosis in association with jejunal tube feeding. JAAPA. 2010 Nov;23(11):28, 30-2. doi: 10.1097/01720610-201011000-00006.
Results Reference
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PubMed Identifier
16847244
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. doi: 10.1001/archsurg.141.7.701.
Results Reference
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PubMed Identifier
19500889
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.
Results Reference
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PubMed Identifier
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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. doi: 10.1088/0031-9155/52/23/009. Epub 2007 Nov 8.
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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.
Results Reference
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Effects of Bolus and Continuous Nasogastric Feeding on Small Bowel Water Content and Blood Flow
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