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

Trial Summary

What is the purpose of this trial?

The investigators are conducting a 16 week multiple cross-over study (N-of-1 trial) comparing two blenderized tube feeds varying in viscosity in 40 children.

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.

What data supports the effectiveness of the treatment Extremely thick blenderized tube feed, Thick BTF, High-viscosity BTF, Pureed-by-gastrostomy-tube (PBGT) diet, Mildly thick blenderized tube feed, Blenderized Tube Feed, BTF, Mildly Thick BTF?

Research suggests that blenderized tube feeds (BTF) can be as effective as commercial formulas, with some reports of improved feeding tolerance, such as reduced constipation and gagging. Additionally, a study found that BTF resolved some vitamin deficiencies in children, indicating potential nutritional benefits. ^{1 2 3 4 5}

Is blenderized tube feeding safe for humans?

Blenderized tube feeding (BTF) is generally considered safe and has been shown to have fewer side effects compared to commercial formulas. However, there are concerns about potential microbial contamination and the risk of feeding tube blockages due to its higher thickness. ^{1 2 3 5 6}

How is the treatment of blenderized tube feeds unique for feeding disorders?

Blenderized tube feeds (BTF) are unique because they use whole foods and purees, providing a more natural form of nutrition compared to commercial formulas. This treatment can improve feeding tolerance, reducing symptoms like constipation and gagging, and allows for a varied diet similar to oral feeding. ^{1 2 3 4 6}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

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

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

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

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

3. Canada pubmed.ncbi.nlm.nih.gov

Basics of Blenderized Tube Feeds: A Primer for Pediatric Primary Care Clinicians. [2020]

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

Survey study assessing attitudes and experiences of pediatric registered dietitians regarding blended food by gastrostomy tube feeding. [2015]

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

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

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

Pureed by gastrostomy tube diet improves gagging and retching in children with fundoplication. [2011]