Enteral FeedingNCT05848583
Nutritional Tolerance and Safety of a Tube Feeding Formula
A study testing Compleat 1.5 in people with Enteral Feeding, run by Société des Produits Nestlé (SPN) at 1 site in Canada.
Trial summary
This open-label, prospective study will be conducted to assess the nutritional efficacy, safety, and tolerance of a concentrated, enteral formula in medically stable adults, who currently require or will require to be enterally fed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enteral Feeding
- What is being tested?
- Compleat 1.5
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2023to 15 Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medically stable, enterally tube-fed adults with a feeding tube diameter of at least 8 French OR medically stable, adults assessed to require enteral feeding initiation with a feeding tube diameter of at least 8 French (2.6 mm).
- Aged 18 years or older at the time of screening visit.
- Currently tolerating or determined to tolerate enteral feeding and eligible for feeding with a 1.5 kcal/mL formula, as per PI discretion.
- Requires or will require enteral tube feeding to provide 90% or more of their daily nutritional needs without the use of modular(s) for at least 14 days.
- Participant or their Legally Authorized Representatives (LAR) is willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary informed consent (or assent, if capable), carry out all study-related procedures, and communicate effectively with the study staff.
Who cannot join
- Has a condition which contraindicates enteral feeding (e.g., intestinal obstruction).
- Currently using the study formula
- Any medical condition or contraindicated medications deemed exclusionary by the PI as determined by medical/medication history at the time of screening visit.
- Any condition, in the opinion of the PI, that would contraindicate use of the study formula (e.g., need for severe fluid restriction, allergy to formula ingredients, etc.).
- Participation in another interventional clinical study between 30 days prior to screening visit until the end of study.
- Any condition or abnormality that, in the opinion of the QI, would compromise the safety of the participant or the quality of the study data.
- Unable to obtain informed consent.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Bruyere Research Institute - Bruyère Continuing Care Complex Care Program - St Vincent Hospital, 60 Cambridge St N
Ottawa, Ontario, K1R 7A5
About this study
Official title: A Single-Center, Open-Label Study on the Nutritional Adequacy, Tolerability, and Safety of a Standard Tube Feeding Formula in Adult Participants
This open-label, prospective study will be conducted to assess the nutritional efficacy, safety, and tolerance of a concentrated, enteral formula in medically stable adults, who currently require or will require to be enterally fed.
Read the detailed description
In patients unable to meet energy and protein requirements orally, enteral nutrition (EN) often serves as the sole source of nutrition for long-term tube fed individuals in varied care settings. EN formulas are designed to meet patients' macronutrient needs as well as vitamin and mineral needs with the overall objective of establishing and maintaining quality of life and further preventing undesirable outcomes that are associated with malnutrition. Some individuals who might benefit from a formulation with real food ingredients have not been able to do so because they need a more concentrated, higher calorie formula. Compleat® 1.5 is a calorically dense real food containing nutrition formula. This open-label, prospective study will be conducted to assess the nutritional efficacy, safety, and tolerance of a concentrated, plant-based enteral formula with real food ingredients, Compleat® 1.5, in medically stable adults, who currently require or will require to be enterally fed.
- Conditions
- Enteral Feeding
- Being tested
- Compleat 1.5
- Keywords
- enteral nutrition, nutrition, gastrointestinal, tube feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compleat 1.5Other
EN Formula
| Study group | Role | What they receive |
|---|---|---|
| Enteral Nutrition (EN) Formula | Experimental | Enteral formula Receives: Other: Compleat 1.5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional adequacy (caloric goals)
Daily percentage of caloric nutritional goal met for each participant
Measured: 14 days
Secondary outcomes (8)
Nutritional adequacy (protein intake)
Daily percentage of protein goal met for each participant
Measured: 14 days
Frequency of vomiting
Daily report of frequency of vomiting for each participant
Measured: 14 days
Frequency of abdominal pain
Daily report of frequency of abdominal pain for each participant
Measured: 14 days
Frequency of abdominal distention
Daily report of frequency of abdominal distention for each participant
Measured: 14 days
Frequency of reflux
Daily report of frequency of reflux for each participant
Measured: 14 days
Adverse events Adverse events
Frequency and nature of adverse events (AEs).
Measured: 14 days
Frequency of nausea
Daily report of nausea for each participant
Measured: 14 days
Daily stool description and frequency - Bristol stool scale
Daily stool description and frequency (Bristol stool scale) for each participant
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 posted8 May 2023
- Study start1 Mar 2023
- Primary completion15 Nov 2023
- Study completion15 Nov 2023
Why it stopped: Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral FeedingStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single center, open-label
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bruyère Health Research Institute., Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Responsible party
- Sponsor
- Investigators
- Jean Chouinard, MD, Principal investigator, Bruyère Health Research Institute.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848583
- Sponsor's protocol ID
- N02-20-02-T0005
- Other IDs
- 23.01.CA.HCN
- Status last verified
- Nov 2024
- First submitted
- 5 Apr 2023
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label Study on the Nutritional Adequacy, Tolerability, and Safety of a Standard Tube Feeding Formula in Adult Participants
- ClinicalTrials.gov ID
- NCT05848583
- Acronym / sponsor ID
- N02-20-02-T0005
- Conditions
- Enteral Feeding
- Keywords
- enteral nutrition, nutrition, gastrointestinal, tube feeding
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- Bruyère Health Research Institute., Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 8 May 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.
This open-label, prospective study will be conducted to assess the nutritional efficacy, safety, and tolerance of a concentrated, enteral formula in medically stable adults, who currently require or will require to be enterally fed.
Detailed description
In patients unable to meet energy and protein requirements orally, enteral nutrition (EN) often serves as the sole source of nutrition for long-term tube fed individuals in varied care settings. EN formulas are designed to meet patients' macronutrient needs as well as vitamin and mineral needs with the overall objective of establishing and maintaining quality of life and further preventing undesirable outcomes that are associated with malnutrition. Some individuals who might benefit from a formulation with real food ingredients have not been able to do so because they need a more concentrated, higher calorie formula. Compleat® 1.5 is a calorically dense real food containing nutrition formula. This open-label, prospective study will be conducted to assess the nutritional efficacy, safety, and tolerance of a concentrated, plant-based enteral formula with real food ingredients, Compleat® 1.5, in medically stable adults, who currently require or will require to be enterally fed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single center, open-label
| Arm | Type | Receives |
|---|---|---|
| Enteral Nutrition (EN) Formula | Experimental | Other: Compleat 1.5Enteral formula |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Medically stable, enterally tube-fed adults with a feeding tube diameter of at least 8 French OR medically stable, adults assessed to require enteral feeding initiation with a feeding tube diameter of at least 8 French (2.6 mm).
- Aged 18 years or older at the time of screening visit.
- Currently tolerating or determined to tolerate enteral feeding and eligible for feeding with a 1.5 kcal/mL formula, as per PI discretion.
- Requires or will require enteral tube feeding to provide 90% or more of their daily nutritional needs without the use of modular(s) for at least 14 days.
- Participant or their Legally Authorized Representatives (LAR) is willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary informed consent (or assent, if capable), carry out all study-related procedures, and communicate effectively with the study staff.
Key exclusion criteria (7 listed)
- Has a condition which contraindicates enteral feeding (e.g., intestinal obstruction).
- Currently using the study formula
- Any medical condition or contraindicated medications deemed exclusionary by the PI as determined by medical/medication history at the time of screening visit.
- Any condition, in the opinion of the PI, that would contraindicate use of the study formula (e.g., need for severe fluid restriction, allergy to formula ingredients, etc.).
- Participation in another interventional clinical study between 30 days prior to screening visit until the end of study.
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 1.5EN Formula | Other | Enteral Nutrition (EN) Formula |
Primary outcome
Nutritional adequacy (caloric goals)
Time frame: 14 days
Daily percentage of caloric nutritional goal met for each participant
8 secondary outcomes
Nutritional adequacy (protein intake)
Time frame: 14 days
Frequency of vomiting
Time frame: 14 days
Frequency of abdominal pain
Time frame: 14 days
Frequency of abdominal distention
Time frame: 14 days
Frequency of reflux
Time frame: 14 days
Adverse events Adverse events
Time frame: 14 days
Frequency of nausea
Time frame: 14 days
Daily stool description and frequency - Bristol stool scale
Time frame: 14 days
Results and safety
The study was stopped early (reason given: Recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 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.
Jean Chouinard, MD principal investigator
Bruyère Health Research Institute.
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 in people with Enteral Feeding, run by Société des Produits Nestlé (SPN) at 1 site in Canada.
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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 6 Nov 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 Canada. 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 was stopped early (reason given: Recruitment). Results are not available in the source record.
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?
Nutritional adequacy (caloric goals) (time frame: 14 days). 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 6 Nov 2024.