Bolus Pouch Feed Study (NCT05822557) | Clinical Trial Compass
CompletedNot Applicable
Bolus Pouch Feed Study
United Kingdom30 participantsStarted 2023-04-01
Plain-language summary
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.
Who can participate
Age range16 Years – 100 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:
* ≥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.
What they're measuring
1
Health and feeding related quality of life
Timeframe: Baseline to end of intervention (Day 35)