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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01557673
First received: March 12, 2012
Last updated: May 3, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Enteral Feeding
Nasogastric Feeding
Diarrhoea
Dietary Supplement: NG bolus feeding over 5 min
Dietary Supplement: Continuous NG feeding over 4 h
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effects of Bolus and Continuous Nasogastric Feeding on Small Bowel Water Content and Blood Flow

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Small bowel water volume (ml) [ Time Frame: 0-240 min ] [ Designated as safety issue: No ]
    Small bowel water content assessed by magnetic resonance imaging.


Secondary Outcome Measures:
  • Gastric emptying [ Time Frame: 0-240 min ] [ Designated as safety issue: No ]
    Gastric volume assessed by magnetic resonance imaging.

  • Superior mesenteric artery blood flow [ Time Frame: 0-240 min ] [ Designated as safety issue: No ]
    Superior mesenteric artery blood flow and velocity assessed by magnetic resonance imaging.

  • Peptide YY [ Time Frame: 0-240 min ] [ Designated as safety issue: No ]
    Serum concentration of peptide YY

  • Insulin [ Time Frame: 0-240 min ] [ Designated as safety issue: No ]
    Serum concentration of insulin

  • Glucose [ Time Frame: 0-240 min ] [ Designated as safety issue: No ]
    Serum concentration of glucose


Enrollment: 12
Study Start Date: January 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NG bolus feeding over 5 min
Tube bolus (TB): feed administered via syringe through NG tube over 5 min.
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.
Other Name: Resource® Energy Vanilla nutrient drink, Societe des Produits Nestle S.A
Placebo Comparator: Continuous NG feeding over 4 h
Continuous tube drip feeding (TD): feed pump delivered via the NG tube over 4 h.
Dietary Supplement: 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.
Other Name: Resource® Energy Vanilla nutrient drink, Societe des Produits Nestle S.A

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01557673

Locations
United Kingdom
Sir Peter Mansfield Magnetic Resonance Centre
Nottingham, Nottinghamshire, United Kingdom, NG7 2RD
Sponsors and Collaborators
University of Nottingham
Investigators
Principal Investigator: Abeed H Chowdhury, BSc MRCS University of Nottingham
Study Chair: Tim Bowling, MD FRCP Nottingham University Hospitals NHS Trust
  More Information

Publications:

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01557673     History of Changes
Other Study ID Numbers: H062011
Study First Received: March 12, 2012
Last Updated: May 3, 2013
Health Authority: United Kingdom: National Health Service

Keywords provided by University of Nottingham:
Nasogastric
Small bowel water
Diarrhoea
Mesenteric blood flow
Enteral feeding

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014