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Nutritional Drink in Gastroparesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03500354
Recruitment Status : Recruiting
First Posted : April 18, 2018
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Gastroparesis Dietary Supplement: Nutrient drink Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Pilot feasibility open-label study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nutritional Drink in Gastroparesis
Actual Study Start Date : May 10, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nutrient
Nutrient drink
Dietary Supplement: Nutrient drink
High calorie drink with therapeutic supplements




Primary Outcome Measures :
  1. Tolerability will be measured by the Palatability Questionnaire at 2 days [ Time Frame: 2 days post-intervention ]

    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. Tolerability will be measured by the Palatability Questionnaire at 7 days [ Time Frame: 7 days post-intervention ]

    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

  3. Tolerability will be measured by the Palatability Questionnaire at 4 weeks [ Time Frame: 4 weeks post-intervention ]

    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. Safety will be measured by the NIH PROMISE scale at baseline [ Time Frame: 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.

  5. Safety will be measured by the NIH PROMISE scale at 2 weeks [ Time Frame: 2 weeks post-intervention ]

    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. Safety will be measured by the NIH PROMISE scale at 4 weeks [ Time Frame: 4 weeks post-intervention ]

    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.

  7. Safety will be measured by the NIH PROMISE scale at 6 weeks [ Time Frame: 6 weeks post-intervention ]

    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.


Secondary Outcome Measures :
  1. Improvement in gastroparesis symptoms [ Time Frame: Baseline, 2, 4 and 6 weeks ]
    Change in weight compared to baseline

  2. Improvement in gastroparesis symptoms [ Time Frame: Baseline, 2, 4 and 6 weeks ]

    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female or male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03500354


Contacts
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Contact: Pankaj J Pasricha, MD 4105027173 ppasric1@jhmi.edu
Contact: Carmen Roberts 4105027173 ccroberts@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Pankaj J Pasricha, MD    410-550-6766    pasricha@jhu.edu   
Contact: Guillermo A Barahona, MD    4105508871    gbaraho1@jhmi.edu   
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Pankaj Pasricha    410-502-7173      
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Pankaj J Pasricha, MD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03500354    
Other Study ID Numbers: IRB00157677
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
malnutrition
Additional relevant MeSH terms:
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Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms
Nutrients
Growth Substances
Physiological Effects of Drugs