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

RecruitingNAAges 18 Years - anyAllAndrea Charvet
NCT06609213 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 fol

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📋 Eligibility rules (as published)
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.
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What it tests

  • Medical Food
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Where

1 site
Nova Southeastern University, Cathy J, Husman ALS Center
Fort Lauderdale, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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