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Oral Enteral Nutrition Formula for ALS Patients with G-Tube Feeding

This study is looking at whether drinking an enteral nutrition formula (a special liquid food) before getting a G-tube (gastrostomy tube, a feeding tube placed directly into the stomach) can help people with ALS (Amyotrophic Lateral Sclerosis) tolerate the formula better once they start using the G-tube. Many people with ALS need G-tubes for nutrition, but some experience stomach problems or intolerance to the formula. This study will give the enteral nutrition formula by mouth to participants who are planning to get a G-tube within 4 to 6 weeks. Researchers will then check for gastrointestinal (GI) symptoms (like stomach upset) after the G-tube is placed and feeding begins. You can join if you are 18 or older, have a diagnosis of ALS, and are planning to get a G-tube soon. The study aims to see if this approach reduces GI symptoms at 5 weeks.

Study design
This is a single-arm study, meaning all 22 participants will receive the enteral nutrition formula intervention. It is not specified if the study is blinded.
What's involved
Participants will take an enteral nutrition formula by mouth before their G-tube placement and then continue using it via the G-tube. Gastrointestinal symptoms will be assessed at 5 weeks.
Compensation
Not stated in the trial record.
Follow-up
Gastrointestinal symptoms will be measured at 5 weeks after the intervention begins.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06609213

Oral Intake of Enteral Nutrition Formula Preceding Placement and Feeding Via GTube and Its Impact on Formula Intolerance in pALS

Recruiting
NAAges 18+InterventionalPrevention
Andrea Charvet
~22 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:Medical Food

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Gastrointestinal Symptoms
Measured over 5 weeks

Conditions

Amyotrophic Lateral Sclerosis
Gastrointestinal Intolerance
Enteral Nutrition Therapy

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NCT06609213

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Nova Southeastern University, Cathy J, Husman ALS Center

    Fort Lauderdale, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Andrea Charvet, PhD, RDN, LDN
[email protected]
954-262-6901
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Gastrointestinal Symptoms5 weeks

    Gastrointestinal symptoms of feeding intolerance will be monitored weekly using a clinician-administered survey in-person or via phone interview. The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item scale that combines each item into five symptom clusters including reflux, abdominal pain, indigestion, diarrhea, and constipation (Svedlund et al., 1988). Patients rate each item on a 7-point Likert scale (from no discomfort at all to very severe discomfort).