Blenderized Formula for Cerebral Palsy

Overseen By Ana F Alvarez

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Transpyloric feeds, Jejunal tube, Monomeric formulas, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how a blenderized formula affects children with cerebral palsy who receive most of their nutrition through a feeding tube. Researchers seek to assess whether this formula influences gut health, weight, and the need for stomach or laxative medications compared to regular formulas. The trial includes two groups: one using the commercial blenderized formula and the other using standard formulas. It suits children with cerebral palsy who obtain over 75% of their daily calories from tube feeding and have insurance covering the blenderized formula. As an unphased trial, this study provides a unique opportunity to enhance understanding of the benefits of blenderized formulas for these children.

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 focuses on comparing different types of tube feeding formulas.

What prior data suggests that this commercial blenderized formula is safe for children with cerebral palsy?

Research shows that the Commercial Blenderized Formula (CBTF) is generally safe for children. Studies have found that these blenderized tube feedings can improve stomach and digestion issues in kids. This evidence suggests that CBTF is a safe food option.

However, these formulas are not germ-free, posing a risk of infections if proper food hygiene is not followed. While the formula itself is safe, careful preparation and handling are crucial to avoid health problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the commercial blenderized formula for cerebral palsy because it offers a more natural and potentially more nutritious alternative to traditional tube feeding formulas. Unlike standard options, which often rely on synthetic ingredients, this blenderized formula incorporates real food ingredients that can provide a broader range of nutrients. This approach not only mimics a regular diet more closely but may also improve digestion and absorption, leading to better overall health outcomes for individuals with cerebral palsy.

What evidence suggests that this trial's treatments could be effective for cerebral palsy?

Research has shown that children using blenderized diets, such as the Commercial Blenderized Formula (CBTF), may receive better nutrition than those using regular commercial formulas. In this trial, participants will join either the CBTF arm or the commercial formulas (CF) arm. Studies indicate that children on blenderized diets often receive the same or even more essential vitamins and minerals. Blenderized formulas also promote better digestion and a healthier gut. This is particularly important for children with conditions like cerebral palsy, who often face malnutrition and feeding challenges. The formula made with real food ingredients could effectively manage their nutrition. ^{1 4 6 7 8}

Who Is on the Research Team?

Fernando Navarro

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for children with Cerebral Palsy who need nutritional support through tube feeding. It's comparing two types of tube feedings: standard commercial formulas and blenderized foods made commercially. Kids must be stable enough to participate, without recent changes in their feeding regimen.

Inclusion Criteria

I get most of my daily calories through a feeding tube.

My insurance covers a CBTF.

I have been diagnosed with cerebral palsy.

Exclusion Criteria

Receiving <75% of total daily energy requirements from a commercial formula

Use of monomeric formulas

My weight is either below the 5th percentile or above the 85th percentile for my age.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either commercial blenderized tube feed (CBTF) or commercial formulas (CF) to assess various health outcomes

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Commercial Blenderized Formula

Trial Overview The study aims to see if there are differences in gastrointestinal health, gut bacteria, body inflammation markers, weight change, and the need for medications to manage stomach acid or bowel movements between kids on commercial formula versus those on blenderized feeds.

How Is the Trial Designed?

Group I: commercial blenderized tube feed (CBTF) Experimental Treatment 1 Intervention

Group II: commercial formulas (CF) Active Control 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10343860/

Early Tube Feeding Improves Nutritional Outcomes in ... Tube feeding is a life-saving treatment for children with neurological disabilities (ND), who often suffer from malnutrition and feeding disorders.

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1097/MPG.0000000000003601

The Use of Blended Diets in Children With Enteral Feeding ... Reassuringly, the results of the BLEND study showed that participants receiving BD had a similar, if not greater, intake of micronutrients ...

3. bspghan.org.uk bspghan.org.uk/wp-content/uploads/2023/01/the-use-of-blended-diets-in-children-with-enteral.pdf

the-use-of-blended-diets-in-children-with-enteral.pdf Reassuringly, the results of the BLEND study showed that participants receiving BD had a similar, if not greater, intake of micronutrients compared to those who ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9370549/

Blenderised Tube Feeds vs. Commercial Formula This study sought to compare gastrointestinal (GI) symptoms, GI inflammation, and stool microbiome composition between children receiving BTF or CF.

5. sciencedirect.com sciencedirect.com/science/article/pii/S266614972500009X

Formula with real food ingredients for tube feeding in ... The enteral formula containing food-derived ingredients may be a valid option in tube feeding management for children with neuromuscular disorders.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S026156141631336X

Nutritional and microbiological quality of commercial and ... These homemade blended diets are often described as nutritionally unbalanced, have an increased risk for food contamination, and may compromise enteral access ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1097/MPG.0000000000002853

Outcomes and Safety of Blenderized Tube Feedings in ... Our data suggest that BTF is a safe dietary intervention that may improve gastrointestinal symptoms in pediatric patients. Further prospective ...

8. tandfonline.com tandfonline.com/doi/full/10.1080/03007995.2022.2052514

Real food in enteral nutrition for chronically ill children This article illustrates the use of a tube feeding formula with real food ingredients in pediatric patients with various complex conditions.