Oral Intake of Enteral Nutrition Formula Preceding Placement and Feeding Via G-Tube and Its Impact on Formula Intolerance in pALS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Gastrointestinal Symptoms
研究概览
简要总结
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:
- 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?
- 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:
- 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.
- 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.
- 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.
详细描述
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 28.6% 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention
This is a single arm study in which all participants receive the intervention.
干预措施: Medical Food (Other)
结局指标
主要结局
Gastrointestinal Symptoms
时间窗: 5 weeks
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).
次要结局
- Dietary Intake(5 weeks)
研究者
Andrea Charvet
Assistant Professor
Nova Southeastern University