Clinical trial · Interventional
Bolus Pouch Feed Study
A Study Evaluating a Newly Designed Nutritional Tube Feeding Pouch for Bolus Feeding in Adults
NCT05822557CI-TRIAL-00086499completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Gastrointestinal Dysfunction | — | UNRESOLVED | — |
| Neurological Disorder | — | UNRESOLVED | — |
| Oral Complication | — | UNRESOLVED | — |
| Stroke | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bolus Pouch Feed | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bolus Pouch Feed
- description
- A 250 ml feeding pouch containing 400 kcal.
- interventionNames
- Other: Bolus Pouch Feed
Primary outcomes (1)
- measure
- Health and feeding related quality of life
- timeFrame
- Baseline to end of intervention (Day 35)
- description
- At baseline, and at the mid-point and end of the intervention period, health and feeding related quality of life will be assessed by the FACT-EQ questionnaire.
Secondary outcomes (7)
- measure
- Ease of administration
- timeFrame
- Baseline to end of intervention (Day 35)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.