Nutritional Tolerance and Safety of a Tube Feeding Formula (NCT05848583) | Clinical Trial Compass
TerminatedNot Applicable
Nutritional Tolerance and Safety of a Tube Feeding Formula
Stopped: Recruitment
Canada3 participantsStarted 2023-03-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.