Oral Intake of Enteral Nutrition Formula Preceding Placement and Feeding Via GTube and Its Impact on Formula Intolerance in pALS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAndrea Charvet
About this trial
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 selected medical facility. For the following two weeks +- 2 days participants will be directed to feed via Gtube the same number of cartons of the enteral nutrition formula used orally on phase I and make no changes to their current oral intake.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Medical Food
Other interventionEnteral nutrition formula will be used both by mouth and via feeding tube. This product is considered a medical food.
Treatment groups
22 Participants
are divided into 1 treatment groupGroup A: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Gastrointestinal Symptoms
Gastrointestinal symptoms of feeding intolerance will be monitored weekly using a clinician-administered survey in-person or via phone interview. The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item scale that combines each item into five symptom clusters including reflux, abdominal pain, indigestion, diarrhea, and constipation (Svedlund et al., 1988). Patients rate each item on a 7-point Likert scale (from no discomfort at all to very severe discomfort).
Time frame
5 weeksSecondary outcomes
1
Dietary Intake
To determine dietary intake of each participant, a food diary will be completed by the participant, with or without the aid of a caregiver, for the duration of the study. Patients and caregivers will be provided instructions on how to complete the food diary and will be directed to record intake at the time of consumption. For each week, the food diary must be completed for a minimum of 3 days and a maximum of 7 days. The weekly intake of selected nutrients will be averaged. A diet analysis software will be utilized to analyze the dietary intake information obtained. Nutritionist Pro, by Axxya Systems, is a software application for nutrition technology and data that uses the Nutrition Raw Database of Foods and Beverages to calculate nutrition values, a system compliant with USA requirements.
Time frame
5 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Andrea Charvet
Lead sponsor
Nova Southeastern University
Sponsor institution
Nova Southeastern University
Collaborator
Source ClinicalTrials.gov