Status:
RECRUITING
Oral Intake of Enteral Nutrition Formula Preceding Placement and Feeding Via GTube and Its Impact on Formula Intolerance in pALS
Lead Sponsor:
Andrea Charvet
Collaborating Sponsors:
Nova Southeastern University
Conditions:
Amyotrophic Lateral Sclerosis
Gastrointestinal Intolerance
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 inter...
Detailed Description
Brief Background: Amyotrophic lateral sclerosis (ALS) is a progressive and fatal neurodegenerative disease. Over 82% of patients with ALS (pALS), develop dysphagia as disease progresses. Dysphagia le...
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.
Key Trial Info
Start Date :
January 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06609213
Start Date
January 10 2025
End Date
June 1 2026
Last Update
August 19 2025
Active Locations (1)
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1
Nova Southeastern University, Cathy J, Husman ALS Center
Fort Lauderdale, Florida, United States, 33314