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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how blenderized diets—pureed real foods like fruits and vegetables delivered through a feeding tube—affect gastroesophageal reflux, which is the backflow of stomach acid into the esophagus. Researchers aim to determine if these diets reduce issues like hospital visits and improve symptoms compared to regular formula feeds. Participants will receive various mixes of blenderized foods and formulas, such as Blenderized Enteral Tube Feeds and Real Foods Blends, to evaluate their effects. The trial seeks children and young adults, ages 1-21, who already use a gastrostomy tube and can manage specific feeding schedules. As an unphased trial, this study provides a unique opportunity to enhance understanding of the benefits of blenderized diets for those using feeding tubes.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that blenderized enteral tube feeds and Real Foods Blends are generally well-tolerated by patients. Studies have found that children receiving these blenderized feeds had fewer hospital visits and better gastrointestinal health compared to those on regular formula. This suggests that these feeds are not only safe but may also improve overall health.

Elecare Jr is a special formula for children who cannot digest regular or partially broken-down proteins. It provides all essential nutrients and is well-tolerated by children with special dietary needs.

Nourish, made from organic whole foods and free from common allergens, is designed for children using feeding tubes and provides all necessary vitamins and minerals.

These products have been used safely in various settings, showing positive results in terms of tolerance and nutrition. Although specific details on side effects are not provided, their widespread use and improvements in health suggest they are safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these blenderized diets for enteral feeding intolerance because they offer a more natural and potentially better-tolerated alternative to standard commercial formulas. Unlike traditional formulas, these diets use real food ingredients, which may be easier for the body to digest and absorb. This approach could lead to fewer digestive issues and provide a more balanced nutrition profile, mimicking regular meals more closely. By exploring different combinations of real food blends, Elecare, and Nourish, the trial aims to identify the most effective sequences for improving tolerance and overall nutrition in patients.

What evidence suggests that this trial's treatments could be effective for enteral feeding intolerance?

Research shows that children receiving blenderized tube feeds (pureed whole foods given through a tube), such as those in the Real Foods Blends arm of this trial, experience fewer hospital visits and better gut health compared to those on standard formulas. Studies have found that these feeds lead to less nausea, vomiting, and other digestive problems. Similarly, the Nourish formula, a plant-based tube feeding option tested in this trial, reduces symptoms like retching and constipation in children. In contrast, Elecare Jr., another formula under study, effectively aids children with food allergies and improved health outcomes in over half of the patients studied. Overall, these options appear promising for enhancing children's tolerance to feedings and reducing digestive symptoms. ^{1 3 5 6 7}

Who Is on the Research Team?

Bridget M Hron, MD

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12314578/

State‐of‐the‐art review of blenderized diets—Status and ... Patients and caregivers of those who receive BTFs as compared to CMFs for home enteral nutrition report improved quality of life perceptions.

2. realfoodblends.com realfoodblends.com/clinical-research/?srsltid=AfmBOorjSorsC3hAW3Pt8VBZIKR7Vpxm7D0oApXSbOTYNGMt8YQhDK0z

Clinical Research | Real Food Blends Blenderized Diet ... “BTF resulted in significantly less reported nausea, vomiting, bloating, diarrhea, and constipation compared with commercial EN. Conclusions: This is the first ...

3. aspenjournals.onlinelibrary.wiley.com aspenjournals.onlinelibrary.wiley.com/doi/abs/10.1002/ncp.11087

Clinical outcomes associated with blenderized tube feedings ... The purpose of this review is to analyze clinical outcomes in adults who use a BTF formula as their primary nutrition source. A literature ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10200265/

Comparison of Home-Blenderized Formula and ... Compared to CEF, BGTF has been shown to decrease the side effects of gagging, vomiting, constipation, retching, eczema, and oral feeding ...

5. mdpi.com mdpi.com/2076-3417/13/4/2173

The Impact of Blenderized Tube Feeding on ... Paramount, for example, is the improvement in feeding tolerance (reduction in reflux, retching/gagging, constipation). This, indeed, greatly ...

6. realfoodblends.com realfoodblends.com/clinical-research/?srsltid=AfmBOoqWyaq_IUdINNY07sNvt2vq1A9Qjb8IlPM33h1aXhHWX84fTru7

Clinical Research | Real Food Blends Blenderized Diet ... BGF appears to enhance enteral tolerance and new food acceptance in SBS patients. At the start of the study, 8/17 children were exclusively G-tube fed and ...

7. med.virginia.edu med.virginia.edu/ginutrition/wp-content/uploads/sites/199/2014/06/Parrish-Dec-14.pdf

Blenderized Tube Feeding: Suggested Guidelines to ... A patient who is having tolerance issues or allergy to a commercial enteral formula may also be a candidate after discussion with the medical team and dietitian ...