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A Trial to Investigate the Effect of Different Supplements on Fluid and Sodium Status in Short Bowel

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ClinicalTrials.gov Identifier: NCT02686606
Recruitment Status : Enrolling by invitation
First Posted : February 19, 2016
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
London North West Healthcare NHS Trust

Brief Summary:
Patients with short bowel intestinal failure are recommended to aim for a diet high in energy and protein. Some patients have difficulties in achieving recommended intakes and additional nutrition may be provided by oral nutritional supplements. There is very little research completed on which is the best oral nutritional supplement for patients. The aim of the study is to see the effect different oral nutritional supplements have on your stoma or fistula output and levels of hydration.

Condition or disease Intervention/treatment Phase
Short Bowel Syndrome Dietary Supplement: Vital 1.5 Dietary Supplement: Ensure Plus Dietary Supplement: elemental 028 Other: water Not Applicable

Detailed Description:
After written consent is obtained, patients will be asked to fast from 12.00am on day one. At 08.00am patients will be asked to pass urine and to empty their stoma bag. After this they will be asked to drink 200ml of the ONS which they have been randomised to test on day one over a 30 minute period. Urine and intestinal output will be collected into two separate containers over the next 6 hours. During this time the patient will not be permitted to eat or drink other fluids. After 6 hours the patient will be able to eat and drink normally. The urine and intestinal output will be weighed and then an aliquot will be stored in a -20oC freezer before being sent for analysis. Day two is a washout day when the patient will be able to eat and drink normally. Day three will be the same as day one but the patient will have the other ONS that they did not have on day one. No changes will be made to the patient's usual anti diarrhoeal and/or anti motility agents or parenteral support during the study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Crossover Trial to Investigate the Effect of Different Oral Nutritional Supplements on Fluid and Sodium Status in Patients With Short Bowel Intestinal Failure
Study Start Date : January 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vital 1.5
200ml orally over 30 minutes
Dietary Supplement: Vital 1.5
Oral nutritional supplement

Active Comparator: Ensure Plus
200ml orally over 30 minutes
Dietary Supplement: Ensure Plus
Oral nutritional supplement

Experimental: Elemental 028
200ml orally over 30 minutes
Dietary Supplement: elemental 028
Oral nutritional supplement

Active Comparator: water
200ml orally over 30 minutes
Other: water
water




Primary Outcome Measures :
  1. Change in faecal sodium [ Time Frame: Day 1 and 3 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients (>18 years)
  • Residual length of small bowel <200cm determined either at operation or radiologically.
  • Patients with a stoma or an established enterocutaneous fistula
  • Normal hydration status (urinary sodium >20mmol/L)

Exclusion Criteria:

  • Dehydration (urinary sodium <20mmol/L)
  • Patients with short bowel and a jejunocolonic anastomosis
  • Current sepsis of any cause
  • Addition/amendment to anti-diarrhoeal or anti motility agents in the last 3 days
  • Severe gastrointestinal obstruction or structural abnormality of the intestine
  • Active Crohn's disease - assessed using two of the three parameters:

CReactive Protein >10 Albumin <30g/L Platelets >400

  • Participation in another intervention trial which may affect intestinal absorption
  • Nil by mouth
  • Unable or unwilling to provide consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02686606


Sponsors and Collaborators
London North West Healthcare NHS Trust
Investigators
Principal Investigator: alison culkin, PhD London Northwest Healthcare Trust

Responsible Party: London North West Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT02686606     History of Changes
Other Study ID Numbers: NWLondonH
First Posted: February 19, 2016    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Peer reviewed journal

Additional relevant MeSH terms:
Short Bowel Syndrome
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Pathologic Processes