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Enteral Nutrition Formula for ALS

N/A
Recruiting
Research Sponsored by Andrea Charvet
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Planned tube feeding placement within the following 4 to 6 weeks
Be older than 18 years old
Must not have
History of Crohn's disease, inflammatory bowel disease, irritable bowel syndrome, celiac disease, food allergies and/or sensitivities to any of the formula ingredients, neurodegenerative disease diagnosis outside of ALS, or other concomitant disorder that might contribute to GI symptoms
Diagnosis of frontotemporal dementia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if giving patients with ALS a certain type of nutrition drink before getting a feeding tube will help them tolerate the tube better. The study will look at if patients who meet more of

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves dietary intervention with an enteral nutrition formula, potential side effects may include gastrointestinal issues such as nausea, bloating, or discomfort related to food intolerance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a tube feeding placement soon.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of GI or certain other health issues.
Select...
I have been diagnosed with frontotemporal dementia.
Select...
I need a feeding tube due to severe malnutrition or other reasons.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Gastrointestinal Symptoms
Secondary study objectives
Dietary Intake

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
This is a single arm study in which all participants receive the intervention.

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Who is running the clinical trial?

Andrea CharvetLead Sponsor
Nova Southeastern UniversityOTHER
101 Previous Clinical Trials
11,964 Total Patients Enrolled
1 Trials studying Amyotrophic Lateral Sclerosis
34 Patients Enrolled for Amyotrophic Lateral Sclerosis
~15 spots leftby Jun 2025
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