Nutritional Drink in Gastroparesis

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.

Study Overview

• Status: Withdrawn
• Conditions: Gastroparesis
• Intervention / Treatment: Dietary supplement: Nutrient drink

Detailed Description

Primary objective:

To evaluate the safety and tolerability of the nutritional drink in gastroparesis patients.

Secondary objective:

To evaluate the efficacy of the nutritional drink in gastroparesis patients.

Study Procedures This study will be a pilot, open-label, trial in gastroparesis patients. A total of 20 patients will be recruited from the gastroenterology gastroparesis clinic. If the volunteer meets eligibility criteria, a co-investigator will contact the patient to schedule a study visit with a nutritionist and obtain a written consent. The contact and screening information of patients that are successfully recruited will be documented, placed in the participant's study folder and stored in a locked cabinet in the research unit. Any information documented during the screening process for patients who do not meet basic eligibility criteria or do not wish to participate will be immediately destroyed.

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, day 7 and at the end of the study to make sure patients are tolerating the drink. Participants will be allowed to consume water and food as desired during the study period but will need to maintain an accurate food diary for at least one week prior to enrollment and during the study (at 2 weeks and at 4 weeks) along with weight measurements at baseline, 2 weeks, 4 weeks and 6 weeks. The participants will be asked to complete a palatability questionnaire. They will also complete the Gastroparesis Cardinal Symptom Index (GCSI) daily diary and the PROMISE scale prior to enrollment as a baseline for their symptoms and again at 2 weeks, 4 weeks (end of the study) and 6 weeks. Changes in these scales from baseline will determine the efficacy and possibly side effects of the nutritional drink.

Study duration and number of study visits required of research participants:

4 weeks, initial study visit with a nutritionist for screening and consenting followed by 3 follow-up phone calls on day 2, day 7 and at 4 weeks (the end of the study) and a final study visit at 6 weeks (2 weeks after finishing the study)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pankaj J Pasricha, MD; Phone Number: 4105027173; Email: ppasric1@jhmi.edu
• Study Contact Backup: Name: Carmen Roberts; Phone Number: 4105027173; Email: ccroberts@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutrient; Nutrient drink	Dietary supplement: Nutrient drink; High calorie drink with therapeutic supplements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in gastroparesis symptoms	Change in weight compared to baseline	Baseline, 2, 4 and 6 weeks
Improvement in gastroparesis symptoms	Changes in the Gastroparesis Cardinal Symptom Index (GCSI) daily diary as compared to baseline. This is a six point severity scale (0-5 with 0= none and 5 = very severe) that rates the following symptoms; Nausea; Early satiety; Postprandial fullness; Bloating; Upper abdominal pain; Retching; Vomiting; Stomach fullness; Loss of appetite; Stomach or belly visibly large	Baseline, 2, 4 and 6 weeks

Collaborators and Investigators

• Sponsor: Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2019
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: April 2, 2018
• First Submitted That Met QC Criteria: April 16, 2018
• First Posted (Actual): April 18, 2018

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: malnutrition
• Additional Relevant MeSH Terms: Digestive System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Gastroparesis
• Other Study ID Numbers: IRB00157677

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No