Enteral Nutrition Formula for ALS

Overseen By Andrea Charvet, PhD, RDN, LDN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Andrea Charvet

Disqualifiers: Crohns, IBS, Celiac, Dementia, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

22 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how consuming a special nutrition formula before receiving a feeding tube might affect individuals with ALS, a disease affecting nerve cells in the brain and spinal cord. The study aims to determine if starting the nutrition formula early can ease the body's adjustment to tube feeding later. Participants must have an ALS diagnosis and plan to receive a feeding tube soon. The trial focuses on whether early nutrition can slow disease progression and reduce stomach issues during tube feeding. As an unphased trial, it offers a unique opportunity to contribute to understanding ALS nutrition management.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you are advised to maintain your usual food and beverage intake during the study.

What prior data suggests that this enteral nutrition formula is safe for ALS patients?

Research has shown that tube feeding directly into the stomach is often used for people with ALS who have trouble swallowing. This method is generally safe and helps prevent weight loss. However, one study found that about 28.6% of patients needed to change their feeding formula due to issues like stomach discomfort. While most people do well with this method, some might experience stomach problems. Discussing any concerns with healthcare providers is important to find the best option for each person. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the oral intake of enteral nutrition formula for ALS because it offers a non-invasive approach to support patients' nutritional needs directly. Unlike current treatments that primarily focus on slowing disease progression through medications like Riluzole or Edaravone, this formula aims to enhance overall health and potentially improve quality of life via nutritional support. Its unique delivery method allows for easy administration, which can be especially beneficial for ALS patients who may have difficulty swallowing or maintaining nutritional intake. This approach could complement existing therapies by addressing a critical aspect of patient care that is often overlooked: nutrition.

What evidence suggests that this enteral nutrition formula is effective for ALS?

Research shows that tube feeding is often recommended for people with ALS who have difficulty swallowing. This method helps ensure proper nutrition and prevents issues like weight loss and lung infections from aspiration. However, past data indicates that about 28.6% of patients changed their feeding formula after receiving a feeding tube due to intolerance. Some studies have also noted weight loss and stomach issues in ALS patients using tube feeding. Despite these challenges, tube feeding remains crucial for meeting the nutritional needs of people with ALS. In this trial, all participants will receive an enteral nutrition formula to evaluate its effectiveness and tolerability. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients with motor neuron diseases like ALS, who are about to get a feeding tube (Gtube) placed. They should be able to drink the enteral nutrition formula orally before getting the Gtube and must not change their usual diet during the study.

Inclusion Criteria

My neurologist diagnosed me with ALS or a similar motor neuron disease.

I am scheduled for a tube feeding placement soon.

Exclusion Criteria

I have a history of GI or certain other health issues.

Nil per oral status

I have been diagnosed with frontotemporal dementia.

Timeline for a Trial Participant

Pre-Intervention

Participants maintain usual food and beverage intake; dietary intake and GI symptoms data collected

1 week

Data collection via phone calls and email

Phase I

Participants consume enteral nutrition formula to meet estimated nutritional needs; ongoing data collection of dietary intake and GI symptoms

2 weeks

Weekly data collection via phone calls and email

Phase II

Participants feed via Gtube using the same enteral nutrition formula; ongoing data collection of dietary intake and GI symptoms

2 weeks

Weekly data collection via phone calls and email

Follow-up

Participants are monitored for safety and effectiveness after Gtube feeding

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Oral Intake of Enteral Nutrition Formula

Trial Overview

The study tests if drinking a plant-based enteral nutrition formula (Kate Farms 1.4 Standard) before getting a Gtube helps reduce gastrointestinal symptoms of feeding intolerance once they start using the tube for feeding.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

This is a single arm study in which all participants receive the intervention.

Oral Intake of Enteral Nutrition Formula is already approved in United States, European Union for the following indications:

Approved in United States as Enteral Nutrition Formula for:

• Nutritional support for patients with impaired gastrointestinal function
• Pre-operative and post-operative nutrition
• Malnutrition
• Disease-related malnutrition

Approved in European Union as Enteral Nutrition Formula for:

• Nutritional support for patients with impaired gastrointestinal function
• Pre-operative and post-operative nutrition
• Malnutrition
• Disease-related malnutrition

Who Is Running the Clinical Trial?

Andrea Charvet

Lead Sponsor

Trials

1

Recruited

20+

Nova Southeastern University

Collaborator

Trials

103

Recruited

12,000+

Published Research Related to This Trial

There are currently no randomized controlled trials (RCTs) comparing the effectiveness of enteral tube feeding, such as percutaneous endoscopic gastrostomy (PEG), to oral feeding in people with ALS, making it unclear which method is better for survival, nutritional status, or quality of life.

Future RCTs are needed to explore the effects of different enteral tube feeding techniques and timing on the health outcomes of ALS patients, as ethical concerns currently limit such studies comparing enteral feeding to continued oral feeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enteral tube feeding for amyotrophic lateral sclerosis/motor neuron disease. Sulistyo, A., Abrahao, A., Freitas, ME., et al.[2023]

In ALS patients, enteral nutrition via gastrostomy is preferred over nasogastric tubes for long-term nutritional support, especially when oral feeding is insufficient and poses risks like malnutrition and aspiration.

While enteral nutrition can improve nutritional status, its impact on quality of life and survival in ALS patients has not been conclusively proven, highlighting the need for careful timing and evaluation of nutritional needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[What are the means of alimentary function supply and their indications in amyotrophic lateral sclerosis?]. Bouteloup, C.[2006]

Tube feeding is an important method for delivering essential nutrients to patients who cannot eat, and there has been significant improvement in the types and quality of enteral formulas over the past 20 years.

The review highlights the need to understand the specific indications for different enteral formulas and the potential complications that can arise from their use, suggesting a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enteral alimentation: administration and complications. Benya, R., Mobarhan, S.[2019]

There are currently no randomized controlled trials that definitively show whether enteral tube feeding improves survival compared to continuing oral feeding in patients with amyotrophic lateral sclerosis (ALS).

However, evidence from retrospective and prospective studies suggests that enteral tube feeding may offer a survival advantage and potentially improve nutritional status, although the conclusions are tentative and more research is needed, especially regarding quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enteral tube feeding for amyotrophic lateral sclerosis/motor neuron disease. Langmore, SE., Kasarskis, EJ., Manca, ML., et al.[2023]

A formulary for enteral nutrition products was successfully developed at a university hospital, categorizing products based on key variables like osmolality, caloric density, and protein content, which helps streamline inventory and reduce waste.

The new system resulted in no loss from outdated products during the first year, indicating that categorization can effectively manage hospital resources and promote rational use of enteral nutrition without bias towards specific manufacturers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a formulary for enteral nutrition products. Hopefl, AW., Herrmann, VM.[2018]

A survey of 148 healthcare professionals revealed that gastrointestinal side effects, such as fullness and diarrhea, are the main reasons why 53% of ALS patients do not fully comply with enteral nutrition (EN) recommendations.

Despite starting EN, about 50% of patients continued to lose weight, indicating a need for more effective guidelines and management strategies for EN in ALS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey of current enteral nutrition practices in treatment of amyotrophic lateral sclerosis. Zhang, M., Hubbard, J., Rudnicki, SA., et al.[2020]

There are currently no randomized controlled trials that definitively show the benefits of enteral tube feeding compared to continuing oral feeding in patients with amyotrophic lateral sclerosis (ALS), leaving the evidence for its efficacy uncertain.

Some non-randomized studies suggest that enteral tube feeding may offer a tentative survival advantage and potentially improve nutritional status, but more research is needed to confirm these findings and to better understand its impact on quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enteral tube feeding for amyotrophic lateral sclerosis/motor neuron disease. Katzberg, HD., Benatar, M.[2023]

In a study of 159 patients with motor neurone disease (MND) receiving enteral tube feeding, those with percutaneous endoscopic gastrostomy (PEG) or radiologically inserted gastrostomy (RIG) had significantly longer survival compared to those with nasogastric tubes (NGT), highlighting the importance of the feeding method.

Nutritional factors like weight loss and malnutrition were linked to reduced survival, but serious complications from tube insertion were not related to nutritional status, indicating that the choice of feeding method is crucial for patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional factors associated with survival following enteral tube feeding in patients with motor neurone disease. Rio, A., Ellis, C., Shaw, C., et al.[2010]

Citations

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cochranelibrary.com

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clinicaltrials.gov

clinicaltrials.gov/study/NCT06609213

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Data from the Cathy J. Husman ALS Center at NSU Health show that 28.6% of the patients who had a Gtube tube placed changed EN formula due to intolerance.

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Weight loss, body mass index, and predicted FVC at placement showed no increased 30-day morbidity or mortality association. Bulbar-onset ALS ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S2212826312000619

Survey of current enteral nutrition practices in treatment ...

Our survey results show a high frequency of gastrointestinal side effects and weight loss in ALS patients receiving EN. These findings may be limited by ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10511594/

The safety and effectiveness of high-calorie therapy for ...

This meta-analysis comprehensively evaluates the effectiveness and safety of high-calorie therapy for treating ALS.

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Nutrition for Patients with Amyotrophic Lateral Sclerosis ...

Indications for enteral feeding: Enteral tube feeding should be considered in patients who experience weight loss, significant dysphagia, and ...

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med.virginia.edu

med.virginia.edu/ginutrition/wp-content/uploads/sites/199/2022/04/April-2022-ALS.pdf

Nutritional Care of the Patient with Amyotrophic Lateral ...

Dietary supplement use is common though may result in drug-nutrient or nutrient-nutrient interactions. Providers and registered dietitians (RDs) should review ...