Nutritional Tolerance and Safety of a Tube Feeding Formula

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Single-Center, Open-Label Study On The Nutritional Adequacy, Tolerability, And Safety Of A Standard Tube Feeding Formula In Adult Participants

Conditions
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Enteral Feeding

Intervention / Treatment
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* Other: Compleat 1.5


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Single center, open-label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enteral Nutrition (EN) Formula<br>Enteral formula | Other: Compleat 1.5<br>* EN Formula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional adequacy (caloric goals) | Daily percentage of caloric nutritional goal met for each participant | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional adequacy (protein intake) | Daily percentage of protein goal met for each participant | 14 days | 
| Frequency of vomiting | Daily report of frequency of vomiting for each participant | 14 days | 
| Frequency of abdominal pain | Daily report of frequency of abdominal pain for each participant | 14 days | 
| Frequency of abdominal distention | Daily report of frequency of abdominal distention for each participant | 14 days | 
| Frequency of reflux | Daily report of frequency of reflux for each participant | 14 days | 
| Adverse events Adverse events | Frequency and nature of adverse events (AEs). | 14 days | 
| Frequency of nausea | Daily report of nausea for each participant | 14 days | 
| Daily stool description and frequency - Bristol stool scale | Daily stool description and frequency (Bristol stool scale) for each participant | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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enteral nutrition, nutrition, gastrointestinal, tube feeding