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Completed

NCT Number: NCT05822557

Bolus Pouch Feed Study

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.

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Key information

Conditions

Cancer Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Gastrointestinal Dysfunction Neoplasms Nervous System Diseases Neurological Disorder Oral Complication Stroke Vascular Diseases

Age range

16 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Sussex NHS Foundation Trust, Brighton, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bolus Pouch Feed

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Ease of administration

    Time frame: Baseline to end of intervention (Day 35)

    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.

  2. Liking of feeding method

    Time frame: Baseline to end of intervention (Day 35)

    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.

  3. Gastrointestinal tolerance

    Time frame: Baseline to end of intervention (Day 35)

    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©.

  4. Compliance

    Time frame: Baseline to end of intervention (Day 35)

    Compliance with feed prescription will be assessed daily throughout the study by recording how much feed was received, to be recorded by the patient.

  5. Nutrient intake

    Time frame: Baseline to end of intervention (Day 35)

    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.

  6. Body weight (kg)

    Time frame: Baseline to end of intervention (Day 35)

    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.

  7. Adverse Events

    Time frame: Baseline to end of intervention (Day 35)

    All adverse events will be recorded throughout the study.

Sponsors and collaborators

Lead sponsor

Nutricia UK Ltd

Industry

Registry information

Official study title

A Study Evaluating a Newly Designed Nutritional Tube Feeding Pouch for Bolus Feeding in Adults

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 20, 2023
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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