Bolus Pouch Feed Study

Nutricia

Status

Completed

Conditions

Stroke

Neurological Disorder

Oral Complication

Gastrointestinal Dysfunction

Cancer

Treatments

Other: Bolus Pouch Feed

Study type

Interventional

Funder types

Industry

Identifiers

NCT05822557

BOPFS2020

Details and patient eligibility

About

The primary aim of this study is to evaluate the impact of introducing a new enteral tube feed on health and feeding related quality of life. Secondary aims are to assess ease of use, liking, compliance, gastrointestinal tolerance, nutrient intake, anthropometric changes and safety.

Full description

Bolus enteral tube feeding (termed 'bolus feeding') is an increasingly common method of providing nutritional support to home enterally tube fed (HETF) patients, particularly those who are more active and/or require greater flexibility in their feeding regimen. However, current methods of bolus feeding are complex to administer, messy, may be unhygienic, and require and lead to a significant amount of plastic waste. Therefore, there is a clear need for a simpler and optimised way to provide bolus feeds. The aim of this study is to evaluate the impact of introducing a new enteral tube feed on health and feeding related quality of life, ease of use, liking, compliance, gastrointestinal tolerance, nutritional intake, anthropometry and safety. This is a prospective, longitudinal, 28-day intervention study with a 7-day baseline period.

Enrollment

30 patients

Sex

All

Ages

16 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

≥16 years of age
Using or requiring an enteral tube feed as part of nutritional management plan
Using or about to use bolus tube feeding methods at least once daily
Expected to receive at least 400 kcal/day from the intervention feed
Written or electronic informed consent from patient, or verbally given consent countersigned by a witness for those physically unable to sign.

Exclusion criteria

Parenteral nutrition contributing more than 70% of total energy requirements
Patients with major hepatic dysfunction (i.e., decompensated liver disease)
Patients with major renal dysfunction [i.e., requiring filtration or stage 4/5 chronic kidney disease (CKD)]
Patients receiving inpatient care
Participation in other clinical intervention studies within 2 weeks of this study
Adults lacking mental capacity to consent
Allergy to any study product ingredients
Investigator concern regarding ability or willingness of patient to comply with the study requirements.