Blenderized Diets for Enteral Feeding Intolerance

Overseen By Bridget M Hron, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Disqualifiers: Allergy, Nissen fundoplication, Pressure support

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

45 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 2 3 4 5}

How 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. ^{1 2 3 5 6}

Research Team

Bridget M Hron, MD

Principal Investigator

Boston Children's Hospital

Eligibility 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.

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

Treatment Details

Interventions

• Blenderized Enteral Tube Feeds
• Elecare Jr
• Nourish
• Real Foods Blends

Trial Overview 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.

Participant Groups

Group I: Real Foods Blends - Elecare - Nourish Experimental Treatment 3 Interventions

Real Foods Blends for first bolus, Elecare for second bolus, Nourish for third bolus

Group II: Nourish - Real Foods Blends - Elecare Experimental Treatment 3 Interventions

Nourish for first bolus, Real Foods Blends for second bolus, Elecare for first bolus

Group III: Elecare - Nourish - Real Foods Blends Experimental Treatment 3 Interventions

Elecare for first bolus, Nourish for second bolus, Real Foods Blends for third bolus

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Findings from Research

In a study of 58 pediatric patients with short bowel syndrome (SBS), those who received blenderized feeds showed improved gastrointestinal symptoms, particularly reduced diarrhea, although they experienced increased gas.

Patients with colonic resection were more likely to discontinue blenderized feeds, and a subgroup of patients who lost weight despite improved diarrhea often had a history of ileocecal valve and colonic resection, suggesting that careful management and titration of these feeds may be necessary for optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blenderized enteral nutrition in pediatric short gut syndrome: Tolerance and clinical outcomes. Zong, W., Troutt, R., Merves, J.[2023]

In a study involving 43 medically unwell children, switching to an enteral formula with food-derived ingredients led to significant improvements in gastrointestinal symptoms, including retching, flatulence, loose stools, and constipation.

The children also experienced a positive change in weight over one month, indicating that the blended diet not only improved tolerance but may also support better nutritional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitor gastrointestinal tolerance in children who have switched to an "enteral formula with food-derived ingredients": A national, multicenter retrospective chart review (RICIMIX study). O'Connor, G., Watson, M., Van Der Linde, M., et al.[2022]

A survey of 77 pediatric dietitians revealed that while many have concerns about blenderised food for tube-feeding (BFTF), such as nutritional inadequacy and infection risk, their actual clinical experiences showed significantly fewer issues than anticipated.

Despite mixed feelings about BFTF, many dietitians see it as a viable option for supplementing commercial feeds, especially noting benefits like reduced reflux and increased involvement from caregivers, highlighting the need for more evidence-based guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietitians' perceptions and experience of blenderised feeds for paediatric tube-feeding. Armstrong, J., Buchanan, E., Duncan, H., et al.[2017]

A systematic review of six studies involving 219 participants suggests that blended diets (BD) may improve symptoms of diarrhea in adults and children who are tube-fed, which is significant given the prevalence of diarrhea in this population.

While the evidence is not strong enough to draw definitive conclusions about other gastrointestinal symptoms like vomiting or bloating, the potential benefits of BD for diarrhea support its consideration as an alternative to commercial feeds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review examining the impact of blended diets on the gastrointestinal symptoms of people who are enterally fed. Peers, E., Boocock, RC., Burn, N.[2023]

Homemade blenderized diets for enteral nutrition provided significantly lower levels of essential macronutrients and energy, delivering less than 50% of the prescribed values, which raises concerns about their nutritional adequacy.

Commercial enteral diets showed better nutritional quality, with protein levels exceeding prescribed values and lower rates of bacterial contamination, highlighting the safety and efficacy of these products compared to homemade options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional and microbiological quality of commercial and homemade blenderized whole food enteral diets for home-based enteral nutritional therapy in adults. Vieira, MMC., Santos, VFN., Bottoni, A., et al.[2019]

Blenderized tube feeding (BTF) is gaining popularity again as a more natural alternative to commercial formulas, with reports of improved feeding tolerance, including reduced constipation and gagging.

However, there are safety concerns associated with BTF, such as the risk of contamination and potential feeding tube blockages due to increased viscosity of the blends.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reemergence of Blenderized Tube Feedings: Exploring the Evidence. Bobo, E.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Blenderized enteral nutrition in pediatric short gut syndrome: Tolerance and clinical outcomes. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

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]

3. England pubmed.ncbi.nlm.nih.gov

Dietitians' perceptions and experience of blenderised feeds for paediatric tube-feeding. [2017]

4. England pubmed.ncbi.nlm.nih.gov

A systematic review examining the impact of blended diets on the gastrointestinal symptoms of people who are enterally fed. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Nutritional and microbiological quality of commercial and homemade blenderized whole food enteral diets for home-based enteral nutritional therapy in adults. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Reemergence of Blenderized Tube Feedings: Exploring the Evidence. [2018]