Nutritional Drink in Gastroparesis
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 16 - Any |
| Updated: | 2/28/2019 |
| Start Date: | April 1, 2019 |
| End Date: | August 2019 |
| Contact: | Pankaj J Pasricha, MD |
| Email: | ppasric1@jhmi.edu |
| Phone: | 4105027173 |
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.
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.
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)
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)
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
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