Nutritional Drink in Gastroparesis

NCT03500354 | Withdrawn

• 1 other identifier: IRB00157677
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Gastroparesis

Keywords

malnutrition

Outcome Measures

Primary Outcomes (7)

• Tolerability will be measured by the Palatability Questionnaire at 2 days

  Patients will be given enough supply of the nutrition drink for 4 weeks and asked to consume 200 ml of the drink three times daily. A follow-up call will be scheduled on day 2 of the study to make sure patients are tolerating the drink. Tolerability will be measured by the Palatability Questionnaire which rates six items on a scale of 1 to 5 (1= strongly disagree and 5= strongly agree. The six items are: * The formula/supplement tasted very good. * The formula/supplement tasted very bad. * I had no problems drinking the supplement. * Drinking the supplement made me feel ill. * I could drink more of this supplement anytime * I would never drink more of this supplement again

  2 days post-intervention

• Tolerability will be measured by the Palatability Questionnaire at 7 days

  Patients will be given enough supply of the nutrition drink for 4 weeks and asked to consume 200 ml of the drink three times daily. A follow-up call will be scheduled on day 7 of the study to make sure patients are tolerating the drink. Tolerability will be measured by the Palatability Questionnaire which rates six items on a scale of 1 to 5 (1= strongly disagree and 5= strongly agree. The six items are: * The formula/supplement tasted very good. * The formula/supplement tasted very bad. * I had no problems drinking the supplement. * Drinking the supplement made me feel ill. * I could drink more of this supplement anytime * I would never drink more of this supplement again

  7 days post-intervention

• Tolerability will be measured by the Palatability Questionnaire at 4 weeks

  Patients will be given enough supply of the nutrition drink for 4 weeks and asked to consume 200 ml of the drink three times daily. A follow-up call will be scheduled at 4 weeks to make sure patients are tolerating the drink. Tolerability will be measured by the Palatability Questionnaire which rates six items on a scale of 1 to 5 (1= strongly disagree and 5= strongly agree. The six items are: * The formula/supplement tasted very good. * The formula/supplement tasted very bad. * I had no problems drinking the supplement. * Drinking the supplement made me feel ill. * I could drink more of this supplement anytime * I would never drink more of this supplement again

  4 weeks post-intervention

• Safety will be measured by the NIH PROMISE scale at baseline

  This will be measured by the NIH PROMISE scale. This is a 10 point scale (0=none and 10= most severe) that rates the following symptoms: * Pain, especially in the abdomen, chest or back * Abdominal distension (bloating, sensation of excess gas) * Difficulty eating, sensation of food being stuck in the stomach. * Difficulty with bowel movements (constipation or straining) * Nausea and/or vomiting * Thirst * Weakness, lack of energy, fatigue, difficulty moving.

  Baseline

• Safety will be measured by the NIH PROMISE scale at 2 weeks

  This will be measured by the NIH PROMISE scale. This is a 10 point scale (0=none and 10= most severe) that rates the following symptoms: * Pain, especially in the abdomen, chest or back * Abdominal distension (bloating, sensation of excess gas) * Difficulty eating, sensation of food being stuck in the stomach. * Difficulty with bowel movements (constipation or straining) * Nausea and/or vomiting * Thirst * Weakness, lack of energy, fatigue, difficulty moving.

  2 weeks post-intervention

• Safety will be measured by the NIH PROMISE scale at 4 weeks

  This will be measured by the NIH PROMISE scale. This is a 10 point scale (0=none and 10= most severe) that rates the following symptoms: * Pain, especially in the abdomen, chest or back * Abdominal distension (bloating, sensation of excess gas) * Difficulty eating, sensation of food being stuck in the stomach. * Difficulty with bowel movements (constipation or straining) * Nausea and/or vomiting * Thirst * Weakness, lack of energy, fatigue, difficulty moving.

  4 weeks post-intervention

• Safety will be measured by the NIH PROMISE scale at 6 weeks

  This will be measured by the NIH PROMISE scale. This is a 10 point scale (0=none and 10= most severe) that rates the following symptoms: * Pain, especially in the abdomen, chest or back * Abdominal distension (bloating, sensation of excess gas) * Difficulty eating, sensation of food being stuck in the stomach. * Difficulty with bowel movements (constipation or straining) * Nausea and/or vomiting * Thirst * Weakness, lack of energy, fatigue, difficulty moving.

  6 weeks post-intervention

Secondary Outcomes (2)

• Improvement in gastroparesis symptoms

  Baseline, 2, 4 and 6 weeks

• Improvement in gastroparesis symptoms

  Baseline, 2, 4 and 6 weeks

Study Arms (1)

Nutrient

EXPERIMENTAL

Nutrient drink

Dietary Supplement: Nutrient drink

Interventions

Nutrient drink DIETARY_SUPPLEMENT

High calorie drink with therapeutic supplements

Nutrient

Eligibility Criteria

• Age: 16 Years+
• Gender Eligibility Details: Female or male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Currently taking any anti-coagulant

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (2)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Gastroparesis; Malnutrition

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Pankaj J Pasricha, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot feasibility open-label study

Study Record Dates

• First Submitted: April 2, 2018
• First Posted: April 18, 2018
• Study Start: May 10, 2019
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: March 13, 2023

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)