Nutritional Drink in Gastroparesis

Gastroparesis Clinical Trial

Official title:

Nutritional Drink in Gastroparesis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03500354
• Other study ID #: IRB00157677
• Status: Withdrawn
• Phase: N/A
• Start date: May 10, 2019
• Est. completion date: January 2024

Study information

• Verified date: March 2022
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastroparesis

Intervention

Dietary Supplement:
• Nutrient drink
High calorie drink with therapeutic supplements

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Improvement in gastroparesis symptoms	Change in weight compared to baseline	Baseline, 2, 4 and 6 weeks
Secondary	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