Blenderized Tube Feeds for Feeding Disorders

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Disqualifiers: Cystic fibrosis, Crohn's disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of thick blenderized tube feeds to assess their effects on children with feeding disorders. Researchers aim to determine which thickness better alleviates symptoms such as nausea and early satiety. Participants will alternate between extremely thick and mildly thick blenderized tube feeds over several weeks. The trial seeks children who primarily depend on tube feeding for nutrition and have experienced symptoms like nausea or bloating for an extended period. As an unphased trial, it provides a unique opportunity to enhance understanding and improve feeding solutions for children with feeding disorders.

Will I have to stop taking my current medications?

The trial requires that your GI-related medications remain stable throughout the study, so you should not stop taking them.

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

Research has shown that blenderized tube feeding (BTF) is generally safe for children. Studies have found that these homemade or store-bought diets often cause fewer side effects than regular commercial formulas.

The thick texture of both very thick and slightly thick blenderized feeds can help reduce issues like acid reflux, a common stomach problem. These feeds are easy for children to handle and can improve symptoms related to the upper digestive system, making them less likely to cause discomfort or other side effects.

In summary, past experiences with blenderized tube feeds suggest they are safe and may help children with feeding problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these blenderized tube feed treatments because they offer a customizable alternative to standard commercial formulas for feeding disorders. Unlike traditional tube feeds that come in fixed consistencies and compositions, these blenderized feeds can be tailored in thickness, which might improve tolerance and digestion for some patients. Additionally, using whole foods in these blends could potentially enhance nutrient absorption and provide a more natural feeding solution. This trial aims to explore how different thickness levels impact feeding outcomes, paving the way for more personalized nutrition strategies.

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

Research has shown that homemade tube feeds can be as effective as store-bought formulas for feeding problems. Studies have found that these homemade feeds can improve children's tolerance, potentially reducing issues like stomach aches or reflux. In this trial, participants will receive either extremely thick or mildly thick blenderized tube feeds, both of which have been linked to improved digestive symptoms. This improvement can enhance the quality of life for children who require tube feeding. Additionally, families often report greater satisfaction with homemade feeds compared to standard store-bought options. Overall, evidence supports the potential benefits of using homemade tube feeds for children with feeding disorders. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for children over 1 year old who get more than 90% of their calories through a G-tube and have been doing so for over 6 months. The G-tube must be at least 14 French in size. They should have moderate upper GI symptoms like nausea or bloating, with a specific symptom score above 2, and not expect to change their GI-related meds during the study.

Inclusion Criteria

I often feel nauseous, bloated, full quickly, and lose my appetite.

I am older than 1 year.

My medications for stomach or bowel issues will not change during the study.

Exclusion Criteria

I have a lung condition like cystic fibrosis or had a lung transplant.

I have an untreated digestive condition like Crohn's or celiac disease.

Use of non-standard enteral formulas (e.g. ketogenic formulas) for the management of metabolic, endocrine, or neurologic rare diseases

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive blenderized tube feeds varying in viscosity in a multiple cross-over design

16 weeks

Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Extremely thick blenderized tube feed
• Mildly thick blenderized tube feed

Trial Overview The study tests two types of blenderized tube feeds that are different in thickness on children with feeding disorders. Over a period of 16 weeks, each child will try both mildly thick and extremely thick feeds to see which works better for them.

How Is the Trial Designed?

Group I: Mildly Thick - Extremely Thick - Mildly Thick - Extremely Thick Experimental Treatment 2 Interventions

Participants will receive 4 weeks Mildly Thick, 4 weeks Extremely Thick, 4 weeks Mildly Thick and 4 weeks Extremely Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen.

Group II: Mildly Thick - Extremely Thick - Extremely Thick - Mildly Thick Experimental Treatment 2 Interventions

Participants will receive 4 weeks Mildly Thick, 4 weeks Extremely Thick, 4 weeks Extremely Thick and 4 weeks Mildly Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen.

Group III: Extremely Thick - Mildly Thick - Mildly Thick - Extremely Thick Experimental Treatment 2 Interventions

Participants will receive 4 weeks Extremely Thick, 4 weeks Mildly Thick, 4 weeks Mildly Thick and 4 weeks Extremely Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen.

Group IV: Extremely Thick - Mildly Thick - Extremely Thick - Mildly Thick Experimental Treatment 2 Interventions

Participants will receive 4 weeks Extremely Thick, 4 weeks Mildly Thick, 4 weeks Extremely Thick and 4 weeks Mildly Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen.

Extremely thick blenderized tube feed is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Thick BTF for:

• Management and treatment of retching, gagging, and volume sensitivity after surgical intervention for severe reflux
• Pediatric enteral feeding intolerance

Approved in Canada as High-viscosity BTF for:

• Pediatric enteral feeding intolerance
• Severe reflux management

Approved in European Union as PBGT diet for:

• Postfundoplication complications
• Pediatric enteral feeding intolerance

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Published Research Related to This Trial

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 of 25 pediatric patients dependent on gastrostomy tube feedings, blenderized gastrostomy tube feedings (BGTF) showed no significant differences in clinical outcomes compared to commercial enteral formulas (CEF), suggesting BGTF is a viable alternative for nutrition.

Patients on BGTF experienced resolution of certain vitamin deficiencies, indicating potential nutritional benefits, while overall malnutrition status and feeding intolerance remained comparable across all feeding methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Home-Blenderized Formula and Commercial Enteral Formulas for Gastrostomy Tube-Fed Children: A Retrospective, Prospective Cohort Study. Shrager, S., Adigun, A., Motolongo, S., et al.[2023]

The method used to thin blenderized tube feedings (BTFs) significantly affects their viscosity, which is crucial for safe administration through enteral feeding devices.

Factors such as the amount of water added and the presence of non-food ingredients can alter the viscosity of BTFs, highlighting the need for careful preparation to ensure consistency and safety in feeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stir, Shake or Blend: A Comparison of Methods Used to Reduce Viscosity of Blenderized Tube Feedings. Weston, SC., Crespo, A., Harwin, C.[2022]

A survey of pediatric registered dietitians revealed that 58% use and recommend blenderized food by gastrostomy tube (BFGT), primarily due to parent requests and tube feeding intolerance, with 79% reporting positive outcomes.

Despite the positive feedback, 12% of dietitians expressed concerns about BFGT related to safety issues like bacterial contamination and nutrient composition, indicating a need for more information and guidelines on its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey study assessing attitudes and experiences of pediatric registered dietitians regarding blended food by gastrostomy tube feeding. Johnson, TW., Spurlock, A., Pierce, L.[2015]

Blenderized tube feeding (BTF) is gaining popularity, especially among children, due to perceived health benefits and intolerance to commercial formulas, despite limited literature on its safety and outcomes.

Healthcare providers should be knowledgeable about BTF to effectively support families choosing this method, as it reflects a growing trend towards more natural food options in medical nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Basics of Blenderized Tube Feeds: A Primer for Pediatric Primary Care Clinicians. Oparaji, JA., Sferra, T., Sankararaman, S.[2020]

In a study involving 33 children post-Nissen fundoplication surgery, a 'pureed by gastrostomy tube' (PBGT) diet led to an average weight gain of 6.2 g/d and significantly reduced gagging and retching symptoms in over half of the participants.

The PBGT diet was well-tolerated, with 57% of children showing increased oral intake and no reported worsening of symptoms, indicating it is a safe and effective nutritional strategy for managing feeding disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pureed by gastrostomy tube diet improves gagging and retching in children with fundoplication. Pentiuk, S., O'Flaherty, T., Santoro, K., et al.[2011]

Citations

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

State‐of‐the‐art review of blenderized diets—Status and ... The growth in interest and demand for using blenderized tube feeds (BTFs) has outpaced the availability of robust evidence‐based literature that ...

2. withpower.com withpower.com/trial/phase-feeding-disorders-6-2022-4395d

Blenderized Tube Feeds for Feeding Disorders Research suggests that blenderized tube feeds (BTF) can be as effective as commercial formulas, with some reports of improved feeding tolerance, such as reduced ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/jpn3.70240

Blenderized tube feeding for children: A systematic review ... Data suggest that blended diets (BD) may improve upper gastro-intestinal (UGI) symptoms with potential to improve quality of life for patient ...

4. cardinalhealth.com cardinalhealth.com/content/dam/corp/web/documents/literature/cardinal-health-enteral-feeding-pedi-adult.pdf

Optimizing enteral feeding for pediatric and adult patients 27, 31 These two studies concluded that, when delivering moderately and extremely thick formulas (IDDSI level 3-4), the accuracy of delivery ranged from. 14-30% ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8431998/

Blenderized tube feeding for children: an integrative review Most studies demonstrated improvements in health outcomes and greater family satisfaction after replacing the commercial enteral feeding with blenderized tube ...

6. nutricialearningcenter.com nutricialearningcenter.com/globalassets/pdfs/blenderized-tube-feeding/webinar-slides-safe--easy-administration-of-btf.pdf

Safe and Easy Administration of Blenderized Tube Feeding ✓ The thick consistency of blenderized enteral may be beneficial with tube feeding GI intolerance issues. ✓ Data supports the use of a safe home blenderized ...