Study of Oral Enteral Nutrition Formula Before and After G-Tube Placement in ALS Patients to Improve Feeding Tolerance

What this Trial Is About

Researchers are investigating how drinking an enteral nutrition EN formula by mouth before getting a feeding tube Gtube affects tolerance to feeding through the tube in people with amyotrophic lateral sclerosis pALS. ALS is a progressive disease that often leads to swallowing difficulties, weight loss, and malnutrition. This study aims to assess whether better nutrition before Gtube placement slows disease progression and reduces gastrointestinal GI symptoms related to feeding intolerance. The study involves a single group of participants who will all receive the intervention. It has three stages a pre-intervention period where usual diet and symptoms are recorded phase I where participants drink a plant-based EN formula Kate Farms 1.4 Standard for about two weeks to meet their nutritional needs and phase II where, after Gtube placement, participants will feed via the tube with the same formula and amount for about two weeks. Data on dietary intake and GI symptoms will be collected weekly throughout. Participants will complete food diaries and GI symptom surveys regularly, with support from caregivers if needed. Researchers will measure GI symptoms using a standardized scale, dietary intake, body mass index BMI, and functional status using the ALS Functional Rating Scale. The study will analyze how nutrition relates to disease progression and feeding intolerance over a total of approximately five weeks. Weekly data collection and safety monitoring will be done by phone and email, with clinical teams recording any significant GI events.

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