GastroparesisNCT03500354
Nutritional Drink in Gastroparesis
A study testing Nutrient drink in people with Gastroparesis, run by Johns Hopkins University at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Gastroparesis
- What is being tested?
- Nutrient drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 May 2019to Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Johns Hopkins University
Baltimore, Maryland, 21287
About this study
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.
Read the 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)
- Conditions
- Gastroparesis
- Being tested
- Nutrient drink
- Keywords
- malnutrition
- Medical subject headings
- Gastroparesis, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrient drinkDietary supplement
High calorie drink with therapeutic supplements
| Study group | Role | What they receive |
|---|---|---|
| Nutrient | Experimental | Nutrient drink Receives: Dietary Supplement: Nutrient drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks post-intervention
Secondary outcomes (2)
Improvement in gastroparesis symptoms
Change in weight compared to baseline
Measured: 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
Measured: Baseline, 2, 4 and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start10 May 2019
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Why it stopped: PI moved to another institution and closed the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot feasibility open-label study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pankaj J Pasricha, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500354
- Sponsor's protocol ID
- IRB00157677
- Status last verified
- Mar 2022
- First submitted
- 2 Apr 2018
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Drink in Gastroparesis
- ClinicalTrials.gov ID
- NCT03500354
- Acronym / sponsor ID
- IRB00157677
- Conditions
- Gastroparesis
- Keywords
- malnutrition
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI moved to another institution and closed the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 10 May 2019 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot feasibility open-label study
| Arm | Type | Receives |
|---|---|---|
| Nutrient | Experimental | Dietary Supplement: Nutrient drinkNutrient drink |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrient drinkHigh calorie drink with therapeutic supplements | Dietary supplement | Nutrient |
Primary outcome
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
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
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
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.
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.
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.
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.
2 secondary outcomes
Improvement in gastroparesis symptoms
Time frame: Baseline, 2, 4 and 6 weeks
Improvement in gastroparesis symptoms
Time frame: Baseline, 2, 4 and 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pankaj J Pasricha, MD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrient drink in people with Gastroparesis, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability will be measured by the Palatability Questionnaire at 2 days (time frame: 2 days post-intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.