Oral Intake of Enteral Nutrition Formula Before and After G-Tube Placement and Its Effect on Feeding Intolerance in Adults with ALS

What this Trial Is About

Researchers are studying adults with amyotrophic lateral sclerosis (ALS) to see if drinking an enteral nutrition (EN) formula by mouth before gastrostomy tube (Gtube) placement affects tolerance to feeding via the Gtube. ALS is a progressive disease that often causes swallowing difficulties, leading to weight loss and malnutrition. This study aims to understand if oral intake of EN formula impacts gastrointestinal (GI) symptoms related to feeding intolerance after Gtube placement and how nutritional intake relates to disease progression. The study is a single-arm intervention where all participants receive a plant-based EN formula called Kate Farms 1.4 Standard. It has three stages: a pre-intervention period of one week during which patients maintain their usual diet; Phase I, lasting about two weeks, where participants drink the EN formula to meet their estimated nutritional needs alongside their regular diet; and Phase II, lasting about two weeks post-Gtube placement, where the same formula is fed via the Gtube without changing oral intake. Dietary intake and GI symptoms are collected weekly throughout. Participants will keep a food diary with caregiver support and complete weekly surveys on GI symptoms using the Gastrointestinal Symptom Rating Scale. Researchers will collect demographic and clinical data including disease severity and progression. The main outcome is GI symptoms of feeding intolerance measured over five weeks. Secondary outcomes include dietary intake, body mass index, and ALS functional status. Data will be gathered via phone and email, with safety monitoring for any GI events requiring medical attention during the study period.

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