Enteral Feeding IntoleranceRAPNCT03048409
Retrospective Tube Feeding Tolerance in Adults With Intolerance After Switch to a Peptide-Based Formula
An observational study of Enteral Feeding Intolerance, run by Société des Produits Nestlé (SPN) at 1 site in Canada.
Trial summary
A retrospective chart review to assess feeding tolerance in adults who had been switched from an intact protein formula to a peptide-based formula due to feeding intolerance in a complex continuing care facility. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enteral Feeding Intolerance
- What is being tested?
- Enteral Formula
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 24 Jul 2017to 2 Oct 2018
- Phase
- Observational
- 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
Study population: The population studied retrospectively will be adult patients in a chronic care facility dependent on enteral nutrition for 90% or more of their nutritional needs and meeting the inclusion/ exclusion criteria.
Who may be able to join
- > 18 years of age on admission to facility
- Prescribed enteral nutrition with the goal to provide at least 90% of estimated daily calorie and protein requirements for ≥ 2 weeks prior to switch
- Received enteral nutrition with an intact protein formula for a minimum of three days prior to a switch to a peptide-based formula
- Have documentation of intolerance to an intact protein formula, followed by a switch in formula received to a peptide-based formula
- Receiving a peptide-based formula formula for ≥ 2 weeks
- Have documentation of an assessment of feeding tolerance following the switch
- Formulas received must be indicated for use in adults.
Who cannot join
- Abdominal surgery (within past 30 days prior to switch)
- Having any infection, including upper respiratory, viral, gastroenteritis,wound infections, c difficile, at time of switch
- Having documented cow's milk protein allergy at time of switch
- Medical records lacking information on rationale for switch to a peptide-based formula and/or response to change (positive, neutral or negative).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Tube Feeding Tolerance in Adults With Intolerance After Switch to a Peptide-based Formula
A retrospective chart review to assess feeding tolerance in adults who had been switched from an intact protein formula to a peptide-based formula due to feeding intolerance in a complex continuing care facility.
- Conditions
- Enteral Feeding Intolerance
- Being tested
- Enteral Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral FormulaOther
Enteral feeding with a peptide-based formula.
| Study group | Role | What they receive |
|---|---|---|
| Enteral tube fed adults | Enteral formula Receives: Other: Enteral Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feeding tolerance - Gastric residuals
no change, tolerance improved, tolerance worsened
Measured: Up to 30 days after formula switch
Feeding tolerance - gagging/retching
no change, tolerance improved, tolerance worsened
Measured: Up to 30 days after formula switch
Feeding tolerance - abdominal distension/gas
no change, tolerance improved, tolerance worsened
Measured: Up to 30 days after formula switch
Feeding tolerance - vomiting
no change, tolerance improved, tolerance worsened
Measured: Up to 30 days after formula switch
Feeding tolerance - stool consistency issues
too hard, too loose
Measured: Up to 30 days after formula switch
Volume of formula consumed in a day vs. goal
documentation of feeding volume after switch as "less than," "about the same as," or "more than" feeding volume achieved before switch
Measured: Up to 30 days after formula switch
Tube feeding interruptions
Number of tube feeding interruptions
Measured: Up to 30 days after formula switch
Secondary outcomes (4)
Weight
Measured body weight
Measured: Prior to and up to 30 days following formula switch.
Medication use
Documented medication use
Measured: Prior to and up to 30 days following formula switch.
Caloric intake
Measured daily calorie intake
Measured: Up to 30 days after formula switch
Protein intake
Measured daily protein intake
Measured: Up to 30 days after formula switch
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start24 Jul 2017
- Primary completion2 Oct 2018
- Study completion2 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral Feeding IntoleranceStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean Chouinard, MD, Principal investigator, St Vincent's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048409
- Sponsor's protocol ID
- 16.06.US.HCN
- Acronym
- RAP
- Status last verified
- Jul 2019
- First submitted
- 7 Feb 2017
- Last updated
- 12 Jul 2019
- 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 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Tube Feeding Tolerance in Adults With Intolerance After Switch to a Peptide-based Formula
- ClinicalTrials.gov ID
- NCT03048409
- Acronym / sponsor ID
- RAP / 16.06.US.HCN
- Conditions
- Enteral Feeding Intolerance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 24 Jul 2017 (actual)
- Primary completion
- 2 Oct 2018 (actual)
- Study completion
- 2 Oct 2018 (actual)
- First posted
- 9 Feb 2017 (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.
A retrospective chart review to assess feeding tolerance in adults who had been switched from an intact protein formula to a peptide-based formula due to feeding intolerance in a complex continuing care facility.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enteral tube fed adults | – | Other: Enteral FormulaEnteral formula |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population studied retrospectively will be adult patients in a chronic care facility dependent on enteral nutrition for 90% or more of their nutritional needs and meeting the inclusion/ exclusion criteria.
Key inclusion criteria (7 listed)
- > 18 years of age on admission to facility
- Prescribed enteral nutrition with the goal to provide at least 90% of estimated daily calorie and protein requirements for ≥ 2 weeks prior to switch
- Received enteral nutrition with an intact protein formula for a minimum of three days prior to a switch to a peptide-based formula
- Have documentation of intolerance to an intact protein formula, followed by a switch in formula received to a peptide-based formula
- Receiving a peptide-based formula formula for ≥ 2 weeks
Key exclusion criteria (4 listed)
- Abdominal surgery (within past 30 days prior to switch)
- Having any infection, including upper respiratory, viral, gastroenteritis,wound infections, c difficile, at time of switch
- Having documented cow's milk protein allergy at time of switch
- Medical records lacking information on rationale for switch to a peptide-based formula and/or response to change (positive, neutral or negative).
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 |
|---|---|---|
| Enteral FormulaEnteral feeding with a peptide-based formula. | Other | Enteral tube fed adults |
Primary outcome
Feeding tolerance - Gastric residuals
Time frame: Up to 30 days after formula switch
no change, tolerance improved, tolerance worsened
Feeding tolerance - gagging/retching
Time frame: Up to 30 days after formula switch
no change, tolerance improved, tolerance worsened
Feeding tolerance - abdominal distension/gas
Time frame: Up to 30 days after formula switch
no change, tolerance improved, tolerance worsened
Feeding tolerance - vomiting
Time frame: Up to 30 days after formula switch
no change, tolerance improved, tolerance worsened
Feeding tolerance - stool consistency issues
Time frame: Up to 30 days after formula switch
too hard, too loose
Volume of formula consumed in a day vs. goal
Time frame: Up to 30 days after formula switch
documentation of feeding volume after switch as "less than," "about the same as," or "more than" feeding volume achieved before switch
Tube feeding interruptions
Time frame: Up to 30 days after formula switch
Number of tube feeding interruptions
4 secondary outcomes
Weight
Time frame: Prior to and up to 30 days following formula switch.
Medication use
Time frame: Prior to and up to 30 days following formula switch.
Caloric intake
Time frame: Up to 30 days after formula switch
Protein intake
Time frame: Up to 30 days after formula switch
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 12 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Enteral Feeding Intolerance
Not yet recruitingObservational study
FACTORS AFFECTİNG ENTERAL FEEDİNG INTOLERANCE İN INTENSİVE CARE UNİT PATİENTS
Patients Who Receive Enteral Nutrition for at Least 72 Hours in the Intensive Care Unit Will be Included in the Study
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Effect of Blenderized Enteral Tube Feeds on Pediatric Upper Gastrointestinal Tract Physiology
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Continuous Versus Intermittent Enteral Feeding and Gastric Residual Volume in Critically Ill Patients
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Gut Microbiota Structure, Functional and Metabolic Profiles, and Composite Biomarkers in ICU Adults With Refractory Enteral Feeding Intolerance
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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
St Vincent's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Enteral Feeding Intolerance, 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 7 inclusion and 4 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 12 Jul 2019. 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 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?
Feeding tolerance - Gastric residuals (time frame: Up to 30 days after formula switch). The study lists 7 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 12 Jul 2019.