Actively Recruiting
Acceptability (Including Gastrointestinal Tolerance and Compliance) of a Paediatric and Adult Bolus Tube Feed With Food Blends
Led by Société des Produits Nestlé (SPN) · Updated on 2026-01-14
50
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the acceptability, gastrointestinal tolerance, and compliance of a bolus tube feed with food blends for children and adults who require enteral feeding due to conditions such as short bowel syndrome, inflammatory bowel disease, total gastrectomy, dysphagia, bowel fistulae, feeding intolerances, developmental disabilities, and disease-related malnutrition. This prospective study aims to collect data on how well patients tolerate and adhere to this dietary management over 28 days. Participants will use the bolus tube feed alongside their usual tube feed or homemade blended diet. The study involves a 7-day period of monitoring gastrointestinal tolerance and a 28-day period of recording formula intake. Each participant acts as their own control, and the study will include up to 50 children and adults who are gastrostomy fed and stable on their current feeding regimen. During the study, participants will be assessed for gastrointestinal tolerance over one week and will keep daily records of formula intake for four weeks. At the end of the study, a patient satisfaction questionnaire will be completed to gather feedback. Researchers will monitor adherence and collect data to evaluate the formula's acceptability and tolerance in the target population.
CONDITIONS
Brief Title
Acceptability and Tolerance Study of Bolus Tube Feed With Food Blends
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 1 year and older requiring one or more bolus tube feeds alongside their usual tube feed or homemade blended diet for disease-related malnutrition
- Patients who are well-established and stable on current enteral tube feed or homemade blended diet
- Patients must be fed by gastrostomy tube
- Written informed consent given by patient or caregiver
You will not qualify if you...
- Inability to comply with the study protocol as judged by the investigator
- Patients under 1 year of age
- Patients with nasogastric or jejunal feeding tubes
- Patients receiving total parenteral nutrition
- Known food allergies to any ingredients listed in appendix 1
- Patients with significant kidney or liver impairment
- Participation in another interventional study within the last 2 weeks
- Patients with known or suspected ileus or mechanical bowel obstruction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 28 days
Participants receive bolus tube feeds with food blends to assess gastrointestinal tolerance and formula intake.
Daily intake and tolerance monitoring for 7 days and formula intake recording for 28 days
Trial Site Locations
Total: 2 locations
1
Queen Medical Hospital Nutrition and Dietetics
Nottingham, United Kingdom, NG7 2UH
Not Yet Recruiting
2
Dietetic Team 1st floor Kings Court 1, Charles Hastings Way,
Worcester, United Kingdom, WR5 1JR
Actively Recruiting
Research Team
S
Sharan Saduera, BSc (Hons) Dietetics
S
Sarah Durnan, PHD, BSc Nutrition Dietetics
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
1
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