Clinical Trials - We Need Better Treatments
I apologize for taking so long to write an article. I, myself, have had a rough year like everyone else seemed to in the GP Community. I lost A LOT of friends last year in my support groups, people I started support groups with, and people I talked to regularly. I logged into Facebook this morning to check on my groups, as I've been sick with pneumonia on top of Gastroparesis for the past week and a half (before that, my husband and I were passing a respiratory virus back and forth) and found another one of my friends had died. She was someone I've known since I first started advocating for Gastroparesis. She was apart of the handful of women who helped start Gastroparesis support groups and build up the Gastroparesis Community. I wanted to dedicated this article to her, and the other friends I've lost. Last year, we lost 48 people. This year, so far, I think the total is four or five people. It's heartbreaking. We need better treatments. Having invasive "treatments" like feeding tubes, which can cause infections and worse, and then on the other end of the spectrum, medicine like Reglan, which can lead to irreversible, neurological disorders. We need medication to help our stomachs, to keep them from cramping so badly, to help them contract.
We need SOME kind of help. I'm so upset at watching my friends suffer and die. I get scared every time I throw up, wondering if it's going to be the last time - if this is the time I'm going to rupture my esophagus and die. I get panic attacks logging on to Facebook, scared I might read another one of my friends has passed away, which always upsets me right away, not only because they passed, but I feel like when I take breaks from Facebook, that I'm letting them down for not being online. I feel like I didn't get to say what I wanted to say to them before they passed. Most of that is on me. I've been not terrified to log into Facebook, but just
If you are interested in joining a clinical trial for Gastroparesis, The National Institute of Diabetes, Digestive, and Kidney Diseases are having people sign up for one now: https://www.niddk.nih.gov/health-information/digestive-diseases/gastroparesis/clinical-trials
Centerwatch has a long list of clinical trials that need volunteers as well: https://www.centerwatch.com/clinical-trials/listings/condition/72/gastroparesis/
ClinicalTrials.gov has a current trial happening as we speak: https://clinicaltrials.gov/ct2/show/NCT03500354
The Trial Says,
"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)
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
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : August 2019
Primary Outcome Measures:
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.
How Gastroparesis Acts in The Body. Source:https://www.pinterest.com/pin/278026976974184742/?lp=true
Secondary Outcome Measures:
Improvement in gastroparesis symptoms [ Time Frame: Baseline, 2, 4 and 6 weeks ]
Change in weight compared to baseline
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.
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
Contact: Pankaj J Pasricha, MD 4105027173 ppasric1@jhmi.edu
Contact: Carmen Roberts 4105027173 ccroberts@jhmi.edu
Locations
United States, Maryland
Johns Hopkins University Active, not recruiting
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Pankaj J Pasricha, MD Johns Hopkins University
More Information
Go to
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03500354 History of Changes
Other Study ID Numbers: IRB00157677
First Posted: April 17, 2018 Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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:
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms"
