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

Trial Summary

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 data supports the effectiveness of the treatment Enteral Nutrition Formula for ALS?

Enteral nutrition, including tube feeding, is commonly used for people with ALS who have trouble swallowing and maintaining their weight. It helps prevent weight loss and related complications, which is important for managing the disease. ^{1 2 3 4 5}

Is enteral nutrition formula safe for humans?

Enteral nutrition formulas, used for people who have trouble swallowing, are generally safe and provide essential nutrients. However, there can be complications related to the feeding devices and formulas, so it's important to follow medical advice and monitor for any issues. ^{1 2 4 6 7}

How is the enteral nutrition formula treatment different from other treatments for ALS?

The enteral nutrition formula is unique for ALS patients because it provides essential nutrients through a tube directly into the stomach, which is crucial for those who have difficulty swallowing (dysphagia) and are at risk of malnutrition. Unlike other treatments, it focuses on maintaining adequate nutrition and preventing weight loss, which are critical for managing ALS symptoms. ^{1 2 3 4 8}

What is the purpose of this trial?

The main objective of the proposed study is to evaluate if oral intake of EN formula preceding Gtube placement will impact tolerance upon placement and feeding via Gtube in pALS. This single arm intervention study all participants will receive the intervention and researchers will utilize validated indicators combined with clinical expertise to assess gastrointestinal symptoms of feeding intolerance before and after the intervention. The main questions this study aims to answer are: 1. Wil participants meeting a greater percentage of their estimated nutritional needs at baseline present a slower disease progression rate and a lower incidence of GI symptoms of feeding intolerance when feeding via Gtube? 2. Will there be significant change in feeding intolerance when oral intake of enteral nutrition formula precedes feeding via Gtube? This proposed study consists of three stages, as follows: 1. Pre-Intervention: The lead in period of one-week preceding intervention phase I will be timed to initiate 3 weeks before the scheduled Gtube placement procedure. Patients will be advised to maintain their usual food and beverage intake. Dietary intake and GI symptoms data will be collected by research personnel. 2. Phase I: Dietary intake data collected from the pre-intervention stage will be averaged and used to determine the number of cartons of enteral nutrition formula needed to meet the participants estimated nutritional needs. For two weeks +- 2 days participants will be directed to drink the number of cartons of a pre-selected enteral nutrition formula to meet their estimated nutritional needs when combined to their current oral dietary intake. A plant based EN formula (Kate Farms 1.4 Standard) commonly prescribed for pALS was selected to be provided to all patients in the study to keep this variable constant. Weekly data collection of dietary intake and GI symptoms will be ongoing. 3. Phase II: At the end of phase I, patients will undergo a Gtube placement at their selected medical facility. For the following two weeks +- 2 days participants will be directed to feed via Gtube the same number of cartons of the enteral nutrition formula used orally on phase I and make no changes to their current oral intake.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 (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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Enteral tube feeding for amyotrophic lateral sclerosis/motor neuron disease. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Enteral tube feeding for amyotrophic lateral sclerosis/motor neuron disease. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Survey of current enteral nutrition practices in treatment of amyotrophic lateral sclerosis. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Enteral tube feeding for amyotrophic lateral sclerosis/motor neuron disease. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Nutritional factors associated with survival following enteral tube feeding in patients with motor neurone disease. [2010]

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

Enteral alimentation: administration and complications. [2019]

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

Developing a formulary for enteral nutrition products. [2018]

8. France pubmed.ncbi.nlm.nih.gov

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