NCT01557673

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 6, 2013

Status Verified

May 1, 2013

Enrollment Period

11 months

First QC Date

March 12, 2012

Last Update Submit

May 3, 2013

Conditions

Enteral FeedingNasogastric FeedingDiarrhoea

Keywords

NasogastricSmall bowel waterDiarrhoeaMesenteric blood flowEnteral feeding

Outcome Measures

Primary Outcomes (1)

  • Small bowel water volume (ml)

    Small bowel water content assessed by magnetic resonance imaging.

    0-240 min

Secondary Outcomes (5)

  • Gastric emptying

    0-240 min

  • Superior mesenteric artery blood flow

    0-240 min

  • Peptide YY

    0-240 min

  • Insulin

    0-240 min

  • Glucose

    0-240 min

Study Arms (2)

NG bolus feeding over 5 min

ACTIVE COMPARATOR

Tube bolus (TB): feed administered via syringe through NG tube over 5 min.

Dietary Supplement: NG bolus feeding over 5 min

Continuous NG feeding over 4 h

PLACEBO COMPARATOR

Continuous tube drip feeding (TD): feed pump delivered via the NG tube over 4 h.

Dietary Supplement: Continuous NG feeding over 4 h

Interventions

NG bolus feeding over 5 minDIETARY_SUPPLEMENT

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.

Also known as: Resource® Energy Vanilla nutrient drink, Societe des Produits Nestle S.A
NG bolus feeding over 5 min
Continuous NG feeding over 4 hDIETARY_SUPPLEMENT

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.

Also known as: Resource® Energy Vanilla nutrient drink, Societe des Produits Nestle S.A
Continuous NG feeding over 4 h

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy
  • Male
  • Able to undergo safe magnetic resonance scanning

You may not qualify if:

  • Female
  • Chronic medical conditions
  • Regular medication
  • Unable to undergo safe magentic resonance scanning
  • Previous abdominal surgery
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sir Peter Mansfield Magnetic Resonance Centre

Nottingham, Nottinghamshire, NG7 2RD, United Kingdom

Location

Related 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. doi: 10.1093/ajcn/47.2.352.

    PMID: 3124596BACKGROUND

  • 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.

    PMID: 14612488BACKGROUND

  • 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.

    PMID: 6421429BACKGROUND

  • 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.

    PMID: 2949027BACKGROUND

  • 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.

    PMID: 21086887BACKGROUND

  • 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.

    PMID: 16847244BACKGROUND

  • 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.

    PMID: 19500889BACKGROUND

  • 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.

    PMID: 18029983BACKGROUND

  • 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.

    PMID: 19909743BACKGROUND

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Abeed H Chowdhury, BSc MRCS

    University of Nottingham

    PRINCIPAL INVESTIGATOR

  • Tim Bowling, MD FRCP

    Nottingham University Hospitals NHS Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2012

First Posted

March 19, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

May 6, 2013

Record last verified: 2013-05

Locations

GB(1)