Clinical trial NCT05848583: Nutritional Tolerance and Safety of a Tube Feeding Formula
Official title: A Single-Center, Open-Label Study on the Nutritional Adequacy, Tolerability, and Safety of a Standard Tube Feeding Formula in Adult Participants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Enteral Feeding
Keywords: enteral nutrition
nutrition
gastrointestinal
tube feeding
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
Collaborators: name: Bruyere Research Institute
name: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
First posted: 2023-05-08
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single center, open-label
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. 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).
2. Aged 18 years or older at the time of screening visit.
3. Currently tolerating or determined to tolerate enteral feeding and eligible for feeding with a 1.5 kcal/mL formula, as per PI discretion.
4. 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.
5. 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.

Exclusion Criteria:

1. Has a condition which contraindicates enteral feeding (e.g., intestinal obstruction).
2. Currently using the study formula
3. Any medical condition or contraindicated medications deemed exclusionary by the PI as determined by medical/medication history at the time of screening visit.
4. 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.).
5. Participation in another interventional clinical study between 30 days prior to screening visit until the end of study.
6. 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.
7. Unable to obtain informed consent.

Primary outcomes:
measure: Nutritional adequacy (caloric goals)
timeFrame: 14 days
Secondary outcomes:
measure: Nutritional adequacy (protein intake)
timeFrame: 14 days
measure: Frequency of vomiting
timeFrame: 14 days
measure: Frequency of abdominal pain
timeFrame: 14 days
measure: Frequency of abdominal distention
timeFrame: 14 days
measure: Frequency of reflux
timeFrame: 14 days
measure: Adverse events Adverse events
timeFrame: 14 days
measure: Frequency of nausea
timeFrame: 14 days
measure: Daily stool description and frequency - Bristol stool scale
timeFrame: 14 days
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Bruyere Research Institute - Bruyère Continuing Care Complex Care Program - St Vincent Hospital, 60 Cambridge St N
state: Ontario
Study officials:
affiliation: Bruyere Research Institute
name: Jean Chouinard, MD
role: PRINCIPAL_INVESTIGATOR
References: