Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02686606
Other study ID # NWLondonH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2016
Est. completion date March 2022

Study information

Verified date March 2021
Source London North West Healthcare NHS Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date March 2022
Est. primary completion date November 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Vital 1.5
Oral nutritional supplement
Ensure Plus
Oral nutritional supplement

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
London North West Healthcare NHS Trust

Outcome

Type Measure Description Time frame Safety issue
Primary Change in faecal sodium Change in faecal sodium Day 1 and 3
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05635747 - A 90 Day Observational Study as an Extension to the Phase 3,Open Labeled Exploratory Study of RELiZORB
Completed NCT01891279 - Elemental Formula in Neonates Post Small Bowel Resection: Improved Weaning From Total Parenteral Nutrition? N/A
Completed NCT00930644 - Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS) Phase 3
Completed NCT01696656 - Prescription Pattern of Adjuvant Drugs and Vitamins in Patients Undergoing Long-term Home Nutritional Support for Intestinal Insufficiency N/A
Completed NCT00910104 - Cholestasis Reversal: Efficacy of IV Fish Oil Phase 2/Phase 3
Completed NCT04981262 - Improved Quality of Life in Children With Intestinal Failure N/A
Completed NCT01930539 - Treatment of Vitamin D Deficiency in Intestinal Rehabilitation Clinic Patients With a Portable Ultraviolet B Lamp N/A
Recruiting NCT05023382 - A Study of Teduglutide in Japanese People With Short Bowel Syndrome
Recruiting NCT04733066 - Quality of Life in Patients With Short Bowel Syndrome Treated Without and With Teduglutide - a Prospective Nested Matched Pair Analysis
Terminated NCT00742157 - Evaluate the Efficacy and Safety Growth Hormone, Glutamine and Diet in Patients With Short Bowel Syndrome (SBS) Phase 4
Completed NCT04743960 - Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition N/A
Completed NCT03690206 - Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS) Phase 3
Terminated NCT02266849 - Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study Phase 3
Completed NCT01306838 - Early Provision of Enteral Microlipid and Fish Oil to Infants With Enterostomy Early Phase 1
Completed NCT01380366 - rHGH and Intestinal Permeability in Intestinal Failure Phase 4
Completed NCT00248573 - Mechanisms of Adaptation in Human Short Bowel Syndrome Phase 1/Phase 2
Withdrawn NCT03371862 - Liraglutide on Decreasing Parenteral Support in Short Bowel Patients (SLIPS) Phase 2
Completed NCT04474743 - Malnutrition in Chronic Gastrointestinal Diseases, Cross-sectional Study
Completed NCT00067860 - Diet/Growth Factor Mechanisms of Gut Adaptation Phase 2
Terminated NCT04046328 - Efficacy, Safety and Tolerability of Enteric-Coated Cholestyramine Capsules for Adult Short Bowel Syndrome Phase 2