Clinical trial NCT03500354: Nutritional Drink in Gastroparesis
Official title: Nutritional Drink in Gastroparesis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gastroparesis
Keywords: malnutrition
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot feasibility open-label study
Primary purpose: TREATMENT

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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: Tolerability will be measured by the Palatability Questionnaire at 2 days
timeFrame: 2 days post-intervention
measure: Tolerability will be measured by the Palatability Questionnaire at 7 days
timeFrame: 7 days post-intervention
measure: Tolerability will be measured by the Palatability Questionnaire at 4 weeks
timeFrame: 4 weeks post-intervention
measure: Safety will be measured by the NIH PROMISE scale at baseline
timeFrame: Baseline
measure: Safety will be measured by the NIH PROMISE scale at 2 weeks
timeFrame: 2 weeks post-intervention
measure: Safety will be measured by the NIH PROMISE scale at 4 weeks
timeFrame: 4 weeks post-intervention
measure: Safety will be measured by the NIH PROMISE scale at 6 weeks
timeFrame: 6 weeks post-intervention
Secondary outcomes:
measure: Improvement in gastroparesis symptoms
timeFrame: Baseline, 2, 4 and 6 weeks
measure: Improvement in gastroparesis symptoms
timeFrame: Baseline, 2, 4 and 6 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Pankaj J Pasricha, MD
role: PRINCIPAL_INVESTIGATOR
References: