Impact of Oral Nutrition Before Gtube Feeding in ALS Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates whether oral intake of enteral nutrition (EN) formula before the placement of a gastrostomy tube (Gtube) affects tolerance to feeding via Gtube in patients with amyotrophic lateral sclerosis (ALS). Participants will undergo a one-week pre-intervention phase followed by the intervention, where their gastrointestinal symptoms will be assessed using validated indicators. The study aims to determine if meeting nutritional needs at baseline correlates with slower disease progression and reduced feeding intolerance. All participants will receive the intervention, allowing for a comprehensive analysis of outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of possible, probable, or definite ALS or motor neuron disease by the treating neurologist (El-Escorial Revisited).
* Planned tube feeding placement within the following 4 to 6 weeks.

Exclusion Criteria:

* History of Crohns 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.
* Nil per oral status.
* Any reason causing the immediate need for a feeding tube placement, including but not limited to severe malnutrition diagnosis.

Where it's running

• Nova Southeastern University, Cathy J, Husman ALS Center
  Fort Lauderdale, Florida, United States Recruiting

Study contacts

• Study coordinator: Andrea Charvet, PhD, RDN, LDN
• Email: acharve1@nova.edu
• Phone: 954-262-6901

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.