Short Bowel SyndromeNCT02686606
A Trial to Investigate the Effect of Different Supplements on Fluid and Sodium Status in Short Bowel
A study testing Vital 1.5 and Ensure Plus in people with Short Bowel Syndrome, run by London North West Healthcare NHS Trust.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Short Bowel Syndrome
- What is being tested?
- Vital 1.5 and Ensure Plus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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:
Show all 10Show fewer
- 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
About this study
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
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.
Read the 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.
- Conditions
- Short Bowel Syndrome
- Being tested
- Vital 1.5, Ensure Plus
- Medical subject headings
- Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vital 1.5Dietary supplement
Oral nutritional supplement
Ensure PlusDietary supplement
Oral nutritional supplement
| Study group | Role | What they receive |
|---|---|---|
| Vital 1.5 | Experimental | 200ml orally over 30 minutes Receives: Dietary Supplement: Vital 1.5 |
| Ensure Plus | Active comparator | 200ml orally over 30 minutes Receives: Dietary Supplement: Ensure Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in faecal sodium
Change in faecal sodium
Measured: Day 1 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionNov 2019
- Study completionMar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- alison culkin, PhD, Principal investigator, London Northwest Healthcare Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686606
- Sponsor's protocol ID
- NWLondonH
- Status last verified
- Mar 2021
- First submitted
- 5 Feb 2016
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02686606
- Acronym / sponsor ID
- NWLondonH
- Conditions
- Short Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Mar 2022 (actual)
- First posted
- 19 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vital 1.5 | Experimental | Dietary Supplement: Vital 1.5200ml orally over 30 minutes |
| Ensure Plus | Active comparator | Dietary Supplement: Ensure Plus200ml orally over 30 minutes |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vital 1.5Oral nutritional supplement | Dietary supplement | Vital 1.5 |
| Ensure PlusOral nutritional supplement | Dietary supplement | Ensure Plus |
Primary outcome
Change in faecal sodium
Time frame: Day 1 and 3
Change in faecal sodium
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
alison culkin, PhD principal investigator
London Northwest Healthcare Trust
Questions about this trial
What is this clinical trial studying?
A study testing Vital 1.5 and Ensure Plus in people with Short Bowel Syndrome, run by London North West Healthcare NHS Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in faecal sodium (time frame: Day 1 and 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.