Nutritional Drink in Gastroparesis
Reason given: PI moved to another institution and closed the study.
Key facts
- Where
- Baltimore, United StatesSee the 2 sites
Where in United States
- Johns Hopkins Bayview Medical CenterBaltimore, United StatesNo longer taking part
- Johns Hopkins UniversityBaltimore, United StatesNo longer taking part
Trial details
- Who runs it
- Johns Hopkins University
- Trial code
- NCT03500354
- Record updated
- 13 March 2023
- Original description
Gastroparesis is a chronic, morbid and costly neuromuscular disorder of the stomach characterized by delayed gastric emptying in the absence of gross structural abnormalities. The periprandial symptoms associated with this disease can preclude adequate oral intake and often lead to weight loss and nutritional deficiencies 1. These manifestations are largely due to impaired gastric accommodation of meals and delayed transfer of food boluses from the stomach into the duodenum2. Consequently, the investigators hypothesize that dietary supplementation with a low volume, hypercaloric nutritional drink can help prevent malnutrition, decrease symptom burden and improve health-related quality of life in this population. Due to the paucity of such a supplement, the investigators developed a novel nutritional drink designed to maximize tolerability in patients with gastroparesis . This nutritional drink was tested on healthy volunteers (phase I) and passed the palatability test. The investigators now aim to test the tolerability of this drink on gastroparesis patients.Read full original descriptionShow less
Gastroparesis is a chronic, morbid and costly neuromuscular disorder of the stomach characterized by delayed gastric emptying in the absence of gross structural abnormalities. The periprandial symptoms associated with this disease can preclude adequate oral intake and often lead to weight loss and nutritional deficiencies 1. These manifestations are largely due to impaired gastric accommodation of meals and delayed transfer of food boluses from the stomach into the duodenum2. Consequently, the investigators hypothesize that dietary supplementation with a low volume, hypercaloric nutritional drink can help prevent malnutrition, decrease symptom burden and improve health-related quality of life in this population. Due to the paucity of such a supplement, the investigators developed a novel nutritional drink designed to maximize tolerability in patients with gastroparesis . This nutritional drink was tested on healthy volunteers (phase I) and passed the palatability test. The investigators now aim to test the tolerability of this drink on gastroparesis patients.
Inclusion: Patients with gastroparesis confirmed with symptoms and a gastric emptying study; Inability to maintain adequate caloric intake by standard dietary measures for gastroparesis due to gastrointestinal symptoms.
Exclusion: Currently taking any anti-coagulant; Recent diagnosis of disorder other than gastroparesis that could affect food intake; Oropharyngeal dysphagia or other condition with risk for aspiration from oral ingestion; Allergic reactions to any of the ingredients of the nutritional drink; Current pregnancy. Pregnancy status will be determined by questioning the potential subject; Patient with gastrostomy/jejunostomy tube feeds or on total parenteral nutrition.