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

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

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.

Study Overview

• Status: Completed
• Conditions: Short Bowel Syndrome
• Intervention / Treatment: Dietary supplement: Vital 1.5; Dietary supplement: Ensure Plus

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
• Enrollment (Actual): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in faecal sodium	Change in faecal sodium	Day 1 and 3

Collaborators and Investigators

• Sponsor: London North West Healthcare NHS Trust
• Investigators: Principal Investigator: alison culkin, PhD, London Northwest Healthcare Trust

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: February 5, 2016
• First Submitted That Met QC Criteria: February 15, 2016
• First Posted (Estimated): February 19, 2016

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Short Bowel Syndrome
• Other Study ID Numbers: NWLondonH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO