Impact of Oral Nutrition Before Gtube Feeding in ALS Patients
Oral Intake of Enteral Nutrition Formula Preceding Placement and Feeding Via G-Tube and Its Impact on Formula Intolerance in pALS
This study is testing if eating a special nutrition formula before getting a feeding tube helps people with ALS handle the tube feedings better and possibly slow down their disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nova Southeastern University Academic / other |
| Locations | 1 site (Fort Lauderdale, Florida) |
| Trial ID | NCT06609213 on ClinicalTrials.gov |
What this trial studies
This study evaluates whether oral intake of enteral nutrition (EN) formula before the placement of a gastrostomy tube (Gtube) affects tolerance to feeding via Gtube in patients with amyotrophic lateral sclerosis (ALS). Participants will undergo a one-week pre-intervention phase followed by the intervention, where their gastrointestinal symptoms will be assessed using validated indicators. The study aims to determine if meeting nutritional needs at baseline correlates with slower disease progression and reduced feeding intolerance. All participants will receive the intervention, allowing for a comprehensive analysis of outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with possible, probable, or definite ALS who are scheduled for Gtube placement within the next 4 to 6 weeks.
Not a fit: Patients with gastrointestinal disorders such as Crohn's disease or those requiring immediate Gtube placement due to severe malnutrition may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve nutritional tolerance and overall quality of life for ALS patients requiring Gtube feeding.
How similar studies have performed: While there is limited data on the specific impact of oral EN intake in ALS patients, similar studies in other populations have shown promise in improving nutritional outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Fort Lauderdale, Florida
- Nova Southeastern University, Cathy J, Husman ALS Center — Fort Lauderdale, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Andrea Charvet, PhD, RDN, LDN
- Email: acharve1@nova.edu
- Phone: 954-262-6901
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.