Nutritional Tolerance and Safety of a Tube Feeding Formula

NCT05848583 | Terminated

• 2 other identifiers: N02-20-02-T000523.01.CA.HCN
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Enteral Feeding

Keywords

enteral nutrition; nutrition; gastrointestinal; tube feeding

Outcome Measures

Primary Outcomes (1)

• Nutritional adequacy (caloric goals)

  Daily percentage of caloric nutritional goal met for each participant

  14 days

Secondary Outcomes (8)

• Nutritional adequacy (protein intake)

  14 days

• Frequency of vomiting

  14 days

• Frequency of abdominal pain

  14 days

• Frequency of abdominal distention

  14 days

• Frequency of reflux

  14 days

Study Arms (1)

Enteral Nutrition (EN) Formula

EXPERIMENTAL

Enteral formula

Other: Compleat 1.5

Interventions

Compleat 1.5 OTHER

EN Formula

Enteral Nutrition (EN) Formula

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Has a condition which contraindicates enteral feeding (e.g., intestinal obstruction).
• Currently using the study formula
• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead
• Bruyère Health Research Institute.: collaborator
• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: collaborator

Study Sites (1)

Bruyere Research Institute - Bruyère Continuing Care Complex Care Program - St Vincent Hospital, 60 Cambridge St N

Ottawa, Ontario, K1R 7A5, Canada

Location

Study Officials

• Jean Chouinard, MD

  Bruyère Health Research Institute.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single center, open-label

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: May 8, 2023
• Study Start: March 1, 2023
• Primary Completion: November 15, 2023
• Study Completion: November 15, 2023
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)