A Trial to Investigate the Effect of Different Supplements on Fluid and Sodium Status in Short Bowel
Primary Purpose
Short Bowel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vital 1.5
Ensure Plus
Sponsored by
About this trial
This is an interventional treatment trial for Short Bowel Syndrome
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vital 1.5
Ensure Plus
Arm Description
200ml orally over 30 minutes
200ml orally over 30 minutes
Outcomes
Primary Outcome Measures
Change in faecal sodium
Change in faecal sodium
Secondary Outcome Measures
Full Information
NCT ID
NCT02686606
First Posted
February 5, 2016
Last Updated
October 13, 2022
Sponsor
London North West Healthcare NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT02686606
Brief Title
A Trial to Investigate the Effect of Different Supplements on Fluid and Sodium Status in Short Bowel
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 Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
November 2019 (Actual)
Study Completion Date
March 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London North West Healthcare NHS Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Bowel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vital 1.5
Arm Type
Experimental
Arm Description
200ml orally over 30 minutes
Arm Title
Ensure Plus
Arm Type
Active Comparator
Arm Description
200ml orally over 30 minutes
Intervention Type
Dietary Supplement
Intervention Name(s)
Vital 1.5
Intervention Description
Oral nutritional supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Ensure Plus
Intervention Description
Oral nutritional supplement
Primary Outcome Measure Information:
Title
Change in faecal sodium
Description
Change in faecal sodium
Time Frame
Day 1 and 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
alison culkin, PhD
Organizational Affiliation
London Northwest Healthcare Trust
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Trial to Investigate the Effect of Different Supplements on Fluid and Sodium Status in Short Bowel
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