Blenderized Diets for Enteral Feeding Intolerance
Recruiting in Palo Alto (17 mi)
Overseen byBridget M Hron, MD
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Boston Children's Hospital
Disqualifiers: Allergy, Nissen fundoplication, Pressure support
No Placebo Group
Trial Summary
What is the purpose of this trial?Blenderized diets consist of a wide range of table foods such as fruits, vegetables, meat and legumes, pureed in a blender and administered via gastrostomy tube. In a recent study, the investigators reported that children receiving blenderized feeds via gastrostomy had fewer total admissions and respiratory admissions, total emergency room visits, and improved gastrointestinal symptom scores compared to those fed formula. The goal of this project is to understand how these diets affect gastroesophageal reflux burden.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators.
What data supports the effectiveness of the treatment Blenderized Enteral Tube Feeds for enteral feeding intolerance?
Research suggests that blended diets, which include whole food components, may help reduce gastrointestinal symptoms like diarrhea in children who are tube-fed. These diets can promote the growth of beneficial gut bacteria, potentially improving feed tolerance and overall clinical outcomes.
12345Is a blenderized diet safe for enteral feeding?
Blenderized diets for enteral feeding are generally considered safe, but there are potential risks of nutritional imbalance and contamination, especially in home-prepared versions. Studies suggest they may help with gastrointestinal symptoms, but careful preparation and monitoring are important to ensure safety.
12345How is the treatment Blenderized Enteral Tube Feeds different from other treatments for enteral feeding intolerance?
Blenderized Enteral Tube Feeds are unique because they use whole food components, which can improve feeding tolerance by reducing issues like constipation and gagging. Unlike standard commercial formulas, these feeds are more natural and can be varied like a regular diet, although they may carry risks of contamination and tube blockage.
12356Eligibility Criteria
This trial is for children and young adults aged 1-21 who are currently using a gastrostomy tube (G-tube) for feeding. They should be able to handle bolus gastric feeds over 30 minutes and use conventional enteral formula. Those with a history of stomach surgery, using airway pressure support, or allergies to the test diets' components cannot participate.Inclusion Criteria
G-tube
I am scheduled for an impedance study for my condition.
Use of conventional enteral formula
Exclusion Criteria
History of allergy or intolerance to any component of the test diets
I use a CPAP or BiPAP machine for breathing support.
I have had a Nissen fundoplication surgery, but it may not be fully intact.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive each of the three test diets (low viscosity conventional formula, medium viscosity commercial blenderized diet, and high viscosity commercial blenderized diet) in a random order in a 3-way crossover design
6 weeks
Multiple visits for diet administration and monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment, including reflux burden and gastrointestinal symptoms
4 weeks
Participant Groups
The study examines how blenderized diets affect kids with feeding tubes compared to standard formulas. Blenderized diets include pureed normal foods like fruits and meats. The focus is on their impact on gastroesophageal reflux, which can cause discomfort and complications in these patients.
3Treatment groups
Experimental Treatment
Group I: Real Foods Blends - Elecare - NourishExperimental Treatment3 Interventions
Real Foods Blends for first bolus, Elecare for second bolus, Nourish for third bolus
Group II: Nourish - Real Foods Blends - ElecareExperimental Treatment3 Interventions
Nourish for first bolus, Real Foods Blends for second bolus, Elecare for first bolus
Group III: Elecare - Nourish - Real Foods BlendsExperimental Treatment3 Interventions
Elecare for first bolus, Nourish for second bolus, Real Foods Blends for third bolus
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Boston Children's HospitalBoston, MA
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Who Is Running the Clinical Trial?
Boston Children's HospitalLead Sponsor
References
Blenderized enteral nutrition in pediatric short gut syndrome: Tolerance and clinical outcomes. [2023]Blenderized feeds consisting of whole food components are emerging as a preferred approach to enteral nutrition. However, there is limited evidence-based guidance for this strategy in short bowel syndrome (SBS). We aimed to explore the tolerance and clinical outcome of blenderized feeds in patients with SBS.
Monitor gastrointestinal tolerance in children who have switched to an "enteral formula with food-derived ingredients": A national, multicenter retrospective chart review (RICIMIX study). [2022]Enteral tube feeding intolerances, such as diarrhea, are commonly reported in children. In the pediatric population, interest is growing in the use of blended diets for the management of enteral feeding intolerances. Fiber within a blended diet stimulates the growth of beneficial gut bacteria, which in turn produce short-chain fatty acids, which are utilized as energy substrates for enterocytes. Enteral formula manufacturers have responded to this trend towards "real-food" blended diets and developed an enteral formula with food-derived ingredients. The aim of this study was to collect data relating to feed tolerance in children who had switched to an "enteral formula with food-derived ingredients."
Dietitians' perceptions and experience of blenderised feeds for paediatric tube-feeding. [2017]There is an emerging interest in the use of blenderised food for tube-feeding (BFTF). This survey explored paediatric dietitians' perceptions and experiences of BFTF use.
A systematic review examining the impact of blended diets on the gastrointestinal symptoms of people who are enterally fed. [2023]Adults and children who are enterally tube-fed can experience adverse gastrointestinal symptoms (GIS). Observational data suggests that blended diets (BD) could mitigate such symptoms, with potential to improve quality of life and clinical outcomes. We present a novel systematic review examining the impact of BD, compared to commercial feeds, on GIS of adults and children who are tube-fed.
Nutritional and microbiological quality of commercial and homemade blenderized whole food enteral diets for home-based enteral nutritional therapy in adults. [2019]Serious nutritional and contamination risks may be involved in the preparation of blenderized tube-feeding diets and in the handling of commercial diets. Their nutritional and microbiological quality in home settings is unknown. The objective of this study was to assess the nutritional and microbiological quality of commercial enteral and homemade blenderized whole foods diets intended to adult patients in home nutritional therapy.
Reemergence of Blenderized Tube Feedings: Exploring the Evidence. [2018]A blenderized tube feeding (BTF) is a mixture of food and liquid that is pureed and administered through a feeding tube. This method of providing nourishment has been used for millenniums. In fact, it could be viewed as the original form of nutrition support. However, over time, the role of BTF has changed. Initially, it was the only method of nourishing a patient who could not sustain himself or herself on oral feeds. With the development of commercial formulas in the mid-20th century, the usage of this feeding modality declined drastically due to the nutrition precision, ease, and sterility of commercial formulas. Recently, there has been a reemergence in blenderized tube feeds, largely due to patient/family request. The modern perception is that BTF is more natural because the nutrition is coming from whole foods and is able to be varied, as it would be in an oral diet. There are also reports of improved feeding tolerance, such as a reduction in constipation and gagging/retching. However, concerns also exist, such as contamination of the blend with microorganisms and increased viscosity causing feeding tube occlusion. This review summarizes key historical points of the diet, discusses the rationale for use, describes points to consider when using a blenderized diet, and reviews the evidence in practice.