Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06609213
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Oral Intake of Enteral Nutrition Formula Preceding Placement and Feeding Via GTube and Its Impact on Formula Intolerance in PALS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Oral Intake of Enteral Nutrition Formula Preceding Placement and Feeding Via G-Tube and Its Impact on Formula Intolerance in PALS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 14 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
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 14 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
Detailed Description:
Brief Background
Amyotrophic lateral sclerosis ALS is a progressive and fatal neurodegenerative disease Over 82 of patients with ALS pALS develop dysphagia as disease progresses Dysphagia leads to a decrease in oral intake associated with the fear of choking and long duration of meals which results in weight loss and consequently malnutrition Malnutrition is associated with a shorter survival time in pALS Feeding via a gastrostomy tube Gtube bypasses oral intake and helps individuals maintain adequate nutrition Research shows that Gtube usage significantly increases survival time in pALS Despite a low risk for major complications with a Gtube placement enteral nutrition EN intolerance is reported in 27-38 of hospitalized and critically ill patients Intolerance frequently defined by the presence of gastrointestinal GI symptoms contributes to poor adherence with nutritional recommendations further weight loss and greater risk of malnutrition Currently there is no data of the prevalence of EN intolerance among pALS or evidence on the impact of oral intake of EN formula on intolerance Data from the Cathy J Husman ALS Center at NSU Health show that 286 of the patients who had a Gtube tube placed changed EN formula due to intolerance
Objectives
The primary aim of this single-arm study is to evaluate whether oral intake of EN formula preceding Gtube placement will impact tolerance upon placement and feeding via Gtube in pALS GI symptoms and dietary intake will be assessed before and after the intervention in a proposed sample of 22 pALS This study involves a multidisciplinary collaboration of professionals in our clinic It was designed with the teams expertise and includes pertinent indicators to assess EN intolerance in a population with great needs and insufficient research Potential therapeutic strategies learned from this study can be incorporated into clinical practice guidelines much needed in the management of Gtube usage to minimize malnutrition increase survival time and improve quality of life in pALS
Specific Aims
Aim 1 Analyze dietary intake before and after placement and feeding via Gtube and determine its relationship with disease progression and GI symptoms of feeding intolerance
Aim 2 Evaluate GI symptoms of feeding intolerance at baseline during oral intake of EN formula and after placement and feeding via Gtube
Study Design
In this single arm intervention study participants will be recruited during their routine multidisciplinary visit at the NSU Health ALS Center The intervention will take place as part of the daily feeding routine of the patients at their desired location This proposed study consists of three stages pre-intervention phase I and phase II Assessments will be completed by the patients andor their caregivers at home and collected weekly by research personnel via phone calls and email The primary outcome measure will be gastrointestinal symptoms of EN intolerance Secondary outcome measures include dietary intake body mass index BMI and ALS Functional Rating Scale ALSFRS-R Treatment fidelity will be assessed at the end of the study
Experimental Procedures and Outcome Measures
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 as described below
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 Nutritional needs will be estimated using the predictive equation researched and developed by Kasarskis and colleagues to estimate energy requirements of ALS patients A plant based EN formula Kate Farms 14 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 as described below
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 Weekly data collection of dietary intake and GI symptoms will be ongoing as described below
Demographics
At baseline the following demographic and clinical information will be obtained age biological sex race ethnicity ALS disease onset type and duration months height weight body mass index BMI malnutrition risk change in BMI from first appointment to current overall disease severity as indexed by the validated the ALS Functional Rating Scale ALSFRS score and disease progression rate change in ALSFRS from first appointment to current
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
Gastrointestinal Symptoms
Gastrointestinal symptoms of feeding intolerance will be monitored weekly using a clinician-administered survey 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 Patients rate each item on a 7-point Likert scale from no discomfort at all to very severe discomfort The recall period is seven days and it is estimated to take about 3 to 5 minutes to complete The clinical team will also be monitoring study participants for any significant gastrointestinal event that requires medical attention at any point in time during the study These will be recorded when the patient contacts the clinic for medical attention or patient-reported if medical attention is sought elsewhere
Data Analysis Descriptive statistics will be used to explore dietary intake and the prevalence of GI symptoms of feeding intolerance in pALS Dietary intake and prevalence of GI symptoms of feeding intolerance before and after placement and feeding via Gtube will be compared within subjects using paired t-test To assess the relationships between the percentage of estimated nutritional needs met at baseline and disease progression indicators as well as the incidence of GI symptoms of feeding intolerance after placement and feeding via Gtube Pearsonamp39s correlation will be used Aim 1 To determine the change in GI symptoms of feeding intolerance at baseline during oral intake of enteral nutrition formula and after placement and feeding via Gtube a one-way repeated measures analysis of variance ANOVA will be conducted Aim2 Statistical analysis will be conducted using SPSS SPSS Statistics V29 IBM with statistical significance at p-value less than 005
Amyotrophic lateral sclerosis ALS is a progressive and fatal neurodegenerative disease Over 82 of patients with ALS pALS develop dysphagia as disease progresses Dysphagia leads to a decrease in oral intake associated with the fear of choking and long duration of meals which results in weight loss and consequently malnutrition Malnutrition is associated with a shorter survival time in pALS Feeding via a gastrostomy tube Gtube bypasses oral intake and helps individuals maintain adequate nutrition Research shows that Gtube usage significantly increases survival time in pALS Despite a low risk for major complications with a Gtube placement enteral nutrition EN intolerance is reported in 27-38 of hospitalized and critically ill patients Intolerance frequently defined by the presence of gastrointestinal GI symptoms contributes to poor adherence with nutritional recommendations further weight loss and greater risk of malnutrition Currently there is no data of the prevalence of EN intolerance among pALS or evidence on the impact of oral intake of EN formula on intolerance Data from the Cathy J Husman ALS Center at NSU Health show that 286 of the patients who had a Gtube tube placed changed EN formula due to intolerance
Objectives
The primary aim of this single-arm study is to evaluate whether oral intake of EN formula preceding Gtube placement will impact tolerance upon placement and feeding via Gtube in pALS GI symptoms and dietary intake will be assessed before and after the intervention in a proposed sample of 22 pALS This study involves a multidisciplinary collaboration of professionals in our clinic It was designed with the teams expertise and includes pertinent indicators to assess EN intolerance in a population with great needs and insufficient research Potential therapeutic strategies learned from this study can be incorporated into clinical practice guidelines much needed in the management of Gtube usage to minimize malnutrition increase survival time and improve quality of life in pALS
Specific Aims
Aim 1 Analyze dietary intake before and after placement and feeding via Gtube and determine its relationship with disease progression and GI symptoms of feeding intolerance
Aim 2 Evaluate GI symptoms of feeding intolerance at baseline during oral intake of EN formula and after placement and feeding via Gtube
Study Design
In this single arm intervention study participants will be recruited during their routine multidisciplinary visit at the NSU Health ALS Center The intervention will take place as part of the daily feeding routine of the patients at their desired location This proposed study consists of three stages pre-intervention phase I and phase II Assessments will be completed by the patients andor their caregivers at home and collected weekly by research personnel via phone calls and email The primary outcome measure will be gastrointestinal symptoms of EN intolerance Secondary outcome measures include dietary intake body mass index BMI and ALS Functional Rating Scale ALSFRS-R Treatment fidelity will be assessed at the end of the study
Experimental Procedures and Outcome Measures
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 as described below
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 Nutritional needs will be estimated using the predictive equation researched and developed by Kasarskis and colleagues to estimate energy requirements of ALS patients A plant based EN formula Kate Farms 14 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 as described below
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 Weekly data collection of dietary intake and GI symptoms will be ongoing as described below
Demographics
At baseline the following demographic and clinical information will be obtained age biological sex race ethnicity ALS disease onset type and duration months height weight body mass index BMI malnutrition risk change in BMI from first appointment to current overall disease severity as indexed by the validated the ALS Functional Rating Scale ALSFRS score and disease progression rate change in ALSFRS from first appointment to current
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
Gastrointestinal Symptoms
Gastrointestinal symptoms of feeding intolerance will be monitored weekly using a clinician-administered survey 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 Patients rate each item on a 7-point Likert scale from no discomfort at all to very severe discomfort The recall period is seven days and it is estimated to take about 3 to 5 minutes to complete The clinical team will also be monitoring study participants for any significant gastrointestinal event that requires medical attention at any point in time during the study These will be recorded when the patient contacts the clinic for medical attention or patient-reported if medical attention is sought elsewhere
Data Analysis Descriptive statistics will be used to explore dietary intake and the prevalence of GI symptoms of feeding intolerance in pALS Dietary intake and prevalence of GI symptoms of feeding intolerance before and after placement and feeding via Gtube will be compared within subjects using paired t-test To assess the relationships between the percentage of estimated nutritional needs met at baseline and disease progression indicators as well as the incidence of GI symptoms of feeding intolerance after placement and feeding via Gtube Pearsonamp39s correlation will be used Aim 1 To determine the change in GI symptoms of feeding intolerance at baseline during oral intake of enteral nutrition formula and after placement and feeding via Gtube a one-way repeated measures analysis of variance ANOVA will be conducted Aim2 Statistical analysis will be conducted using SPSS SPSS Statistics V29 IBM with statistical significance at p-value less than 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None