ToleranceNCT06034951
Acceptability and Tolerance Study of a High Energy Tube Feed with Food Derived Ingredients
A study testing Compleat 1.5 HP in people with Tolerance, run by Société des Produits Nestlé (SPN) at 1 site in United Kingdom.
Trial summary
Enterally fed adults and children who are assessed by the dietitian as requiring an adult high-energy, fibre-containing enteral formula will be recruited. Data from 15 participants are required in order to submit an application to the Advisory Committee on Borderline Substances (ACBS) for product registration. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Tolerance
- What is being tested?
- Compleat 1.5 HP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 May 2023to 22 Dec 2023
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients requiring an enteral tube feed (taking > 60% of energy needs from their feeding tube) as part of their dietary management for disease related malnutrition
- Children 15 years and over
- Adults and children requiring an adult high-energy and fibre-containing formula, as assessed by the dietitian.
- Patients well-established and stable on enteral feeding.
- Willingly given, written, informed consent from patient or consultee
- Willingly given, written assent (if appropriate).
Who cannot join
- Inability to comply with the study protocol, in the opinion of the investigator
- Children under 15 years of age
- Patients receiving mechanical ventilation, sedation or inotropic support
- Patients on total parenteral nutrition
- Known food allergies to any ingredients (see ingredients list) or galactosaemia
- Patients with significant renal or hepatic impairment
Show all 10Show fewer
- Patients with planned changes to medication or treatments during the study period which may alter gastrointestinal function (e.g. chemotherapy). Changes in medications or nutritional products during the study intervention must be documented.
- Participation in another interventional study within 2 weeks of this study.
- Patients with a clinical indication for a low fibre or fibre free diet as advised by the healthcare team.
- Patients with known or suspected ileus or mechanical bowel obstruction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acceptability (including Gastrointestinal Tolerance and Compliance) of a High Energy, Adult Enteral Formula with Food-derived Ingredients.
Enterally fed adults and children who are assessed by the dietitian as requiring an adult high-energy, fibre-containing enteral formula will be recruited. Data from 15 participants are required in order to submit an application to the Advisory Committee on Borderline Substances (ACBS) for product registration.
Read the detailed description
To evaluate the acceptability (including gastrointestinal tolerance and compliance) of a high energy, adult enteral formula with food-derived ingredients.This is a single arm, prospective, multi-centre study to evaluate the gastrointestinal tolerance and compliance over a 14-day period with the new tube feed.
Participants or their caregivers will be provided with 14-day supply of the new tube feed and will be asked to complete a daily diary and short questionnaire to record information allowing assessment of the following:
- Gastrointestinal tolerance
- Compliance with prescribed feed volume
- Conditions
- Tolerance
- Being tested
- Compleat 1.5 HP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compleat 1.5 HPDietary supplement
Patients well established and stable on an enteral tube feed. This group will act as their own controls and switched to the new tube feed.
| Study group | Role | What they receive |
|---|---|---|
| Patients well established on tube feeds will act as their own control | Other | These patients will switch from current to new tube feed to assess acceptability and tolerance Receives: Dietary Supplement: Compleat 1.5 HP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily patient diaries
Daily monitor of gastrointestinal tolerance using questionnaire on increase, decrease or no change
Measured: 14 days
Daily formula intake
mL per day
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start24 May 2023
- Primary completion21 Aug 2023
- Study completion22 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ToleranceStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martha Van Der Linde, Principal investigator, Community Paediatric Dietitian Worcestershire North Nutrition and Dietetic Hastings Way, Worcester. UKAmy Carter, Principal investigator, The Walton Centre NHS Foundation Trust, Liverpool UKSam Ogundere, Principal investigator, Lewisham and Greenwich NHS Trust London UKAdrian Gilson, Principal investigator, Newham General Hospital London UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034951
- Sponsor's protocol ID
- Compleat002
- Status last verified
- Apr 2024
- First submitted
- 22 Aug 2023
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: will upload the data as it becomes available
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability (including Gastrointestinal Tolerance and Compliance) of a High Energy, Adult Enteral Formula with Food-derived Ingredients.
- ClinicalTrials.gov ID
- NCT06034951
- Acronym / sponsor ID
- Compleat002
- Conditions
- Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 24 May 2023 (actual)
- Primary completion
- 21 Aug 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 13 Sep 2023 (actual)
- 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.
Enterally fed adults and children who are assessed by the dietitian as requiring an adult high-energy, fibre-containing enteral formula will be recruited. Data from 15 participants are required in order to submit an application to the Advisory Committee on Borderline Substances (ACBS) for product registration.
Detailed description
To evaluate the acceptability (including gastrointestinal tolerance and compliance) of a high energy, adult enteral formula with food-derived ingredients.This is a single arm, prospective, multi-centre study to evaluate the gastrointestinal tolerance and compliance over a 14-day period with the new tube feed.
Participants or their caregivers will be provided with 14-day supply of the new tube feed and will be asked to complete a daily diary and short questionnaire to record information allowing assessment of the following:
- Gastrointestinal tolerance
- Compliance with prescribed feed volume
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients well established on tube feeds will act as their own control | Other | Dietary Supplement: Compleat 1.5 HPThese patients will switch from current to new tube feed to assess acceptability and tolerance |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients requiring an enteral tube feed (taking > 60% of energy needs from their feeding tube) as part of their dietary management for disease related malnutrition
Key exclusion criteria (10 listed)
- Inability to comply with the study protocol, in the opinion of the investigator
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 |
|---|---|---|
| Compleat 1.5 HPPatients well established and stable on an enteral tube feed. This group will act as their own controls and switched to the new tube feed. | Dietary supplement | Patients well established on tube feeds will act as their own control |
Primary outcome
Daily patient diaries
Time frame: 14 days
Daily monitor of gastrointestinal tolerance using questionnaire on increase, decrease or no change
Daily formula intake
Time frame: 14 days
mL per day
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 23 Sep 2024.
- Individual participant dataSharing planned: No. will upload the data as it becomes available
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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.
Martha Van Der Linde principal investigator
Community Paediatric Dietitian Worcestershire North Nutrition and Dietetic Hastings Way, Worcester. UK
Amy Carter principal investigator
The Walton Centre NHS Foundation Trust, Liverpool UK
Sam Ogundere principal investigator
Lewisham and Greenwich NHS Trust London UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compleat 1.5 HP in people with Tolerance, run by Société des Produits Nestlé (SPN) at 1 site in United Kingdom.
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 6 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 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Daily patient diaries (time frame: 14 days). The study lists 2 primary outcomes in all. 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 23 Sep 2024.