CancerNCT05822557
Bolus Pouch Feed Study
A study testing Bolus Pouch Feed in people with Cancer and Neurological Disorder, run by Nutricia UK Ltd at 15 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- Cancer, Neurological Disorder, Gastrointestinal Dysfunction
- What is being tested?
- Bolus Pouch Feed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 15 sitesUnited Kingdom
- Study dates
- 1 Apr 2023to 25 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United Kingdom15 sites
University Hospitals Sussex NHS Foundation Trust
Brighton
Cambridge University Hospitals NHS Foundation Trust
Cambridge
University Hospitals Coventry and Warwickshire NHS Trust
Coventry
County Durham and Darlington NHS Foundation Trust
Darlington
NHS Tayside
Dundee
Royal Surrey NHS Foundation Trust
Guildford
Betsi Cadwaladr University Health Board
Holywell
Calderdale & Huddersfield NHS Foundation Trust
Huddersfield
Leicestershire Partnership NHS Trust
Leicester
North East London NHS Foundation Trust
London
Northumbria Healthcare NHS Foundation Trust
Newcastle upon Tyne
Nottingham University Hospitals NHS Trust
Nottingham
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield
Southern Health NHS Foundation Trust
Southampton
South Warwickshire NHS Foundation Trust
Warwick
About this study
Official title: A Study Evaluating a Newly Designed Nutritional Tube Feeding Pouch for Bolus Feeding in Adults
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.
Read the detailed 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.
- Being tested
- Bolus Pouch Feed
- Medical subject headings
- Neoplasms, Nervous System Diseases, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bolus Pouch FeedOther
Following the 7-day baseline period, all patients will enter the 28-day intervention period, where they will receive the intervention feed daily. The feed prescription will be determined on an individual basis by the Dietitian responsible for the patient's nutritional management
| Study group | Role | What they receive |
|---|---|---|
| Bolus Pouch Feed | Experimental | A 250 ml feeding pouch containing 400 kcal. Receives: Other: Bolus Pouch Feed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health and feeding related quality of life
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.
Measured: Baseline to end of intervention (Day 35)
Secondary outcomes (7)
Ease of administration
At baseline, and at the mid-point and end of the intervention period, patients and dietitians will be asked to rate the ease of administering the enteral tube feed via a Likert-style questionnaire. Patients will also count the amount of feeding equipment required to administer the enteral feed at baseline, and at the midpoint and end of the intervention period.
Measured: Baseline to end of intervention (Day 35)
Liking of feeding method
At baseline, and at the mid-point and end of the intervention period, patients will be asked to rate their liking of their usual feeding method or of the intervention feed, respectively via a 7-point Likert scale questionnaire.
Measured: Baseline to end of intervention (Day 35)
Gastrointestinal tolerance
A standardised gastrointestinal (GI) tolerance questionnaire to capture perceived severity (none, mild, moderate or severe) of common gastrointestinal symptoms (diarrhoea, constipation, bloating, abdominal discomfort, vomiting and nausea) will be recorded at the end of each week. Information about bowel movements will also be collected using the Bristol Stool Chart©.
Measured: Baseline to end of intervention (Day 35)
Compliance
Compliance with feed prescription will be assessed daily throughout the study by recording how much feed was received, to be recorded by the patient.
Measured: Baseline to end of intervention (Day 35)
Nutrient intake
At baseline, and at the mid-point and end of the intervention period, the dietitian will conduct a 24-h dietary recall with the patient to record all food, drink and nutritional feeds provided in the 24 h prior. Trained research staff will subsequently analyse all records utilising a nutritional software package (Nutritics Professional v3.09, Nutritics, Ireland) for macro- and micro-nutrient intakes.
Measured: Baseline to end of intervention (Day 35)
Body weight (kg)
At baseline and at the end of the intervention period, body weight (kg) will be measured using standard methods to the nearest 0.1 kg using a weighing scale without heavy clothing.
Measured: Baseline to end of intervention (Day 35)
Adverse Events
All adverse events will be recorded throughout the study.
Measured: Baseline to end of intervention (Day 35)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start1 Apr 2023
- Primary completion25 Jan 2024
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, longitudinal, 28-day intervention study with a 7-day baseline period.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia UK Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rebecca Stratton, PhD, Study chair, Nutricia UK Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822557
- Sponsor's protocol ID
- BOPFS2020
- Status last verified
- Feb 2025
- First submitted
- 12 Apr 2022
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating a Newly Designed Nutritional Tube Feeding Pouch for Bolus Feeding in Adults
- ClinicalTrials.gov ID
- NCT05822557
- Acronym / sponsor ID
- BOPFS2020
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nutricia UK LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, longitudinal, 28-day intervention study with a 7-day baseline period.
| Arm | Type | Receives |
|---|---|---|
| Bolus Pouch Feed | Experimental | Other: Bolus Pouch FeedA 250 ml feeding pouch containing 400 kcal. |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- ≥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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bolus Pouch FeedFollowing the 7-day baseline period, all patients will enter the 28-day intervention period, where they will receive the intervention feed daily. The feed prescription will be determined on an individual basis by the Dietitian responsible for the patient's nutritional management | Other | Bolus Pouch Feed |
Primary outcome
Health and feeding related quality of life
Time frame: Baseline to end of intervention (Day 35)
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.
7 secondary outcomes
Ease of administration
Time frame: Baseline to end of intervention (Day 35)
Liking of feeding method
Time frame: Baseline to end of intervention (Day 35)
Gastrointestinal tolerance
Time frame: Baseline to end of intervention (Day 35)
Compliance
Time frame: Baseline to end of intervention (Day 35)
Nutrient intake
Time frame: Baseline to end of intervention (Day 35)
Body weight (kg)
Time frame: Baseline to end of intervention (Day 35)
Adverse Events
Time frame: Baseline to end of intervention (Day 35)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Cancer
RecruitingPhase 1
A Study to Evaluate DMR-001 in Participants With CALR-mutant Myeloproliferative Neoplasms
Myeloproliferative Neoplasms (MPNs)
Recruiting
Role of ERBT Plus Intravesical BCG in Intermediate-Risk or High-Risk NMBC
Bladder Cancer
RecruitingPhase 2
Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia
RecruitingPhase 1
A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
B-cell Mediated Autoimmune Disorders
RecruitingPhase 3
A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant
Multiple Myeloma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Stratton, PhD study chair
Nutricia UK Ltd
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bolus Pouch Feed in people with Cancer and Neurological Disorder, run by Nutricia UK Ltd at 15 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health and feeding related quality of life (time frame: Baseline to end of intervention (Day 35)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.