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

NCT02686606 | Completed

• 1 other identifier: NWLondonH
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Short Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in faecal sodium

  Change in faecal sodium

  Day 1 and 3

Study Arms (2)

Vital 1.5

EXPERIMENTAL

200ml orally over 30 minutes

Dietary Supplement: Vital 1.5

Ensure Plus

ACTIVE COMPARATOR

200ml orally over 30 minutes

Dietary Supplement: Ensure Plus

Interventions

Vital 1.5 DIETARY_SUPPLEMENT

Oral nutritional supplement

Vital 1.5

Ensure Plus DIETARY_SUPPLEMENT

Oral nutritional supplement

Ensure Plus

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• London North West Healthcare NHS Trust: lead

MeSH Terms

Conditions

Short Bowel Syndrome

Interventions

Ensure Plus

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• alison culkin, PhD

  London Northwest Healthcare Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: February 19, 2016
• Study Start: January 1, 2016
• Primary Completion: November 1, 2019
• Study Completion: March 1, 2022
• Last Updated: February 13, 2024

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share