Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06609213 · ClinicalTrials.gov registry record · NA
Oral Intake of Enteral Nutrition Formula Preceding Placement and Feeding Via GTube and Its Impact on Formula Intolerance in pALS
A NA study of Amyotrophic Lateral Sclerosis and Gastrointestinal Intolerance, sponsored by Andrea Charvet.
- Recruiting
- Registry status
- NA
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT06609213 is a NA study of Amyotrophic Lateral Sclerosis and Gastrointestinal Intolerance that is actively recruiting participants, run by Andrea Charvet. The registered enrollment target is 22 participants, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06609213, a NA study of Amyotrophic Lateral Sclerosis and Gastrointestinal Intolerance, is actively recruiting participants, sponsored by Andrea Charvet.
- RECRUITING
- Registry status
- NA
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study 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 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 follows: 1. Pre-Intervention: The lead in period of one-week preceding intervention phase I will be timed to initiate 3 weeks before the scheduled Gtube placement procedure. Patients will be advised to maintain their usual food and beverage intake. Dietary intake and GI symptoms data will be collected by research personnel. 2. Phase I: Dietary intake data collected from the pre-intervention stage will be averaged and used to determine the number of cartons of enteral nutrition formula needed to meet the participants estimated nutritional needs. For two weeks +- 2 days participants will be directed to drink the number of cartons of a pre-selected enteral nutrition formula to meet their estimated nutritional needs when combined to their current oral dietary intake. A plant based EN formula (Kate Farms 1.4 Standard) commonly prescribed for pALS was selected to be provided to all patients in the study to keep this variable constant. Weekly data collection of dietary intake and GI symptoms will be ongoing. 3. Phase II: At the end of phase I, patients will undergo a Gtube placement at their
Conditions Studied
Interventions
- OTHER Medical Food
Study Locations (1)
Florida
- Nova Southeastern University, Cathy J, Husman ALS Center - Fort Lauderdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2025-01-10 |
| Est. Completion | 2026-06 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06609213
The ClinicalTrials.gov registry entry for NCT06609213 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (98% lower). The listed sponsor is Andrea Charvet, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which Medical Food is the first listed.
NCT06609213 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT06609213 about?
NCT06609213 is a clinical study titled "Oral Intake of Enteral Nutrition Formula Preceding Placement and Feeding Via GTube and Its Impact on Formula Intolerance in pALS". 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 ...
What is the current status of trial NCT06609213?
This trial is currently recruiting. It is a NA study. The enrollment target is 22 participants. The study started on 2025-01-10. Estimated completion is 2026-06.
What conditions does trial NCT06609213 study?
This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis, Gastrointestinal Intolerance, Enteral Nutrition Therapy.
What interventions are being tested in trial NCT06609213?
The interventions under investigation include: Medical Food (OTHER).
Who is sponsoring clinical trial NCT06609213?
This trial is sponsored by Andrea Charvet, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06609213 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Amyotrophic Lateral Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)
RECRUITING · NA
-
Assessing Perceptual Effects of Interactive Tasks
RECRUITING · NA
-
Spinal Cord Associative Plasticity for ALS
RECRUITING · NA
-
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
RECRUITING · NA
-
Precise Robotically IMplanted Brain-Computer InterfacE
RECRUITING · NA
-
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia
RECRUITING · NA
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.