Gastroparesis Medical Studies Update; Join and/or Keep Up With Clinical Trials

Source: Unknown

Source: Unknown

Source: On The Image but one of my favorites on how to explain Gastroparesis.









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"

Source:https://preferredresearchpartners.com/gastroparesis-infographic/

Take Action: For Many Patients and Their Families, Advocacy is About Helping Themselves and Others

I did NOT write this but this article has a lot of great information in it and I wanted to hang on it it later, to use for research regarding advocacy. I like having all of my sources and things together.


(http://journals.lww.com/neurologynow/Pages/articleviewer.aspx?year=2016&issue=12010&article=00019&type=Fulltext)

By: Kunkle, Frederick

"Karen J. Smith started a support group for people with Parkinson's disease after she was diagnosed with the condition at age 42. When Michael Ellenbogen learned he had an early-onset form of dementia at 49, he used social media to build a community of people interested in finding a cure for Alzheimer's disease. After Catherine (Cathy) DeCreszenzo's husband, Joe, was diagnosed with spinocerebellar ataxia, a rare neurodegenerative disease that causes spastic body movements and problems with balance, she started educating herself about the disorder so she could help him and others. And since her diagnosis of amyotrophic lateral sclerosis (ALS) 19 years ago, Catherine G. Wolf has initiated research projects and fought on behalf of people with disabilities. These four people, and hundreds like them, choose to cope with their diseases by taking action. Whether they're raising awareness or money, participating in clinical trials, providing support, or pressuring politicians, advocates help bring about change that could benefit themselves, their families, and perhaps thousands of other people, now and in the future. Their firsthand experience of living with a neurologic condition gives them a unique perspective.

'Our whole mantra is we need people with the disease out in front,' says Veronica “Ronnie” Todaro, MPH, vice president of national programs at the Parkinson's Disease Foundation. 'It's a core philosophy of the foundation. 'For those who feel called to do more but don't know where to start, we asked patients and their families to trace their paths to advocacy.'

Picture taken from IMGUR.



START WITH YOURSELF

Advocacy begins at home, says Todaro. 'People who make the best advocates are those who have advocated for themselves first,' she says. 'It's hard to help others without your own plan in place.' The first step is to be as educated about your disease as possible. Then work with your doctor and support team to come up with treatment and care that ensures your quality of life. Don't be afraid to ask your doctor or medical team questions, and persist until you get answers, she says.That was an important lesson for the DeCreszenzos. In their search for the right neurologist for Joe, they were uncompromising about finding an expert who was committed to fighting on their behalf. They chose Joseph M. Savitt, MD, PhD, a neurologist at Johns Hopkins University in Baltimore, for his warm demeanor and willingness to answer questions at any time without sugarcoating, says Cathy.




FIND STRENGTH IN NUMBERS

By joining a support group, people often find the courage to speak louder for themselves and others. It emboldened the DeCreszenzos to start their own support group in Newark, DE. When Joe was first diagnosed with ataxia, the couple traveled to Chesapeake, MD, to join a group sponsored by the National Ataxia Foundation. In the early days, the group was especially important because ataxia is extremely rare, Cathy says. Only about 150,000 people in the United States are known to have the condition. Just talking with others fighting a similar disease was helpful, she says. 'They tell you about their challenges, you tell them about yours. You compare notes and see if you can help each other.' Smith, 56, who was diagnosed with Parkinson's disease about 14 years ago after she noticed a tremor in her left ring finger, kept quiet about her disease initially. 'I didn't want people to know I had it,' she says.

Her advocacy work began when she formed a support group. From there she established a walk to raise awareness about the disease. She took out books at her local library and asked librarians to put up displays about the disorder. She signed up for newsletters and attended conferences when she could, and she even visited the US Food and Drug Administration (FDA) to learn more about the drug approval process. She joined clinical trials. With every step she became more confident and less depressed, she says. 'By becoming involved, I think I'm making a difference in people's lives. I can say, ‘I know what you're going through. You'll make it.’”

Found at: http://datab.us/Search/Gastroparesis.



RAISE YOUR HAND

Volunteering was another crucial step on the DeCreszenzos' path to advocacy. Together, Joe and Cathy have organized fundraisers, including one in September that raised more than $10,000 for research. Joe, 67, now serves on the National Ataxia Foundation's board of directors. Along the way, Cathy, 60, says she discovered new strengths. 'Asking for money comes very easily to me because I know it's needed,' she admits. 'Being an advocate helps me deal with what's happening to my family. Every year I get stronger.' The cause has taken on new urgency for the DeCreszenzos since learning that Joe's ataxia is hereditary and one of their daughters has tested positive for the disorder.





JOIN A TRIAL

Besides contributing to research that could lead to a cure or better treatments, participating in a clinical study gives advocates credibility to encourage others to join. The Parkinson's Advocates in Research program, created by Todaro, looks for individuals who have participated in studies. It has trained more than 230 people with Parkinson's disease or their caregivers on how to guide researchers and find ways to work together in the search for a cure. Many advocates who work with the foundation have been in dozens of clinical trials. 'It's taking control of your disease,' Todaro says. 'It's saying, ‘I can play a role in making things better.’'If you participate in a clinical trial, use that opportunity to establish a relationship with the scientists, investigators, and institutions involved. These people are often in the best position to effect change. Being able to communicate concerns also helps ensure that studies focus on the right issues and that researchers design them to be effective and humane,' Todaro says. In September, for example, Parkinson's disease advocates met with the FDA to highlight symptoms and side effects of the disease for which no treatments currently exist, she says.





GET TRAINING

To hone your skills as an advocate, reach out to the national organization for your disorder. The Parkinson's Disease Foundation, for example, has a nationwide program, the People with Parkinson's Advisory Council (PPAC), to identify advocates and leaders, evaluate their abilities and talents, and provide further education and training to support their public advocacy. The council's 14 members serve as advisors on the foundation's research, education, and advocacy programs.

Taken from IMGUR.





GO PUBLIC

For some, the logical extension of their advocacy is speaking to the public, either through media interviews, public forums, or in front of Congress. That's where Ellenbogen, 57, ended up after first establishing a presence on LinkedIn, where he ultimately connected with 6,000 people who could help him understand Alzheimer's or work toward a cure. Ellenbogen, who has lived with the disease for eight years, has worked hard to ensure that the testimony of people with dementia is included in public forums and panels.Ellenbogen's dedication to speaking out earned him an invitation to the World Health Organization forum in Geneva in March 2015; he was the only person with dementia attending who was not there as part of an organization. His letters have been included in the Congressional Record, and he received an appointment to the Pennsylvania Alzheimer's Disease State Planning Committee. 'You're going to get a lot of people telling you ‘no’ and ‘it can't be done.’ You go around those people. You find a way. Don't accept it when someone tells you it can't be done,' he says.






BUILD MOMENTUM

When his mother-in-law was diagnosed with Alzheimer's disease, George Vradenburg, former chief counsel for AOL, started by educating himself about the disease. Then he hosted a gala dinner for the local Washington, DC, chapter of the Alzheimer's Association. As the circle of invitations grew wider, the gala became national. Vradenburg, who was accustomed to moving among the business and political elite of DC, teamed up with former House speaker Newt Gingrich to create a national Alzheimer's study group. Established with the bipartisan support of the Congressional Task Force on Alzheimer's Disease, the group, which included former Supreme Court Justice Sandra Day O'Connor, was charged with developing a coordinated national plan to fight the disease.Still frustrated that not enough was being done, Vradenburg and his wife, Trish, a writer and former journalist, formed USAgainstAlzheimer's in 2010. The philanthropic group has pushed the federal government to adopt timetables for finding a cure or better treatments and has set its sights on accelerating the drug approval process.





ESTABLISH A CHARITY

The impulse to start a foundation or charity is often strong after a devastating diagnosis or event, but Vradenburg suggests that you first think about what you hope to accomplish. Large donors might fund a building for research or back a team of researchers. Others might choose to focus on caregiving, which could mean donating to a specific facility or to research on caregiving, such as using music to alleviate the symptoms of dementia. “Find your purpose. It's not enough to say, ‘I want to cure Alzheimer's,’” Vradenburg says. “Of course you do. Focus on a piece of the issue that matches your budget and fits your passion and where you can have the biggest impact.”

This was found a Google Image search because I wanted people to understand what it's like to have GP.

This was shared to me by a friend and I love what it says.





PLAY TO YOUR STRENGTHS

Wolf, who was at the top of her field in research psychology when she was diagnosed with ALS in 1996, says the will to keep going helped in her legal fight against an insurer that denied her home care 10 years ago, and it's what recently drove her to help revamp the Westchester Library System's website so it's easier for people with disabilities to use. An expert on interaction between humans and technology—she once worked at IBM's Thomas J. Watson Research Center—Wolf, now 68, continues to conduct research on how people with disabilities interact with computers. She also writes articles about living with ALS and posts disability news to her Facebook page. She types by raising and lowering her eyebrows to trigger a computer switch inside a headband.





EVERY STEP COUNTS

Advocacy isn't just about grand gestures. It can be as straightforward as ensuring that the local library has displays or pamphlets about your disease. Or trying to establish a commemorative month for a particular disorder. Or signing an email petition.As Ellenbogen says, anyone can be an advocate. 'If you write a letter to Congress once in a while or reach out to people in some small way to change attitudes, you're still being an advocate,' he says. Vradenburg agrees. Just the act of acknowledging the disease, which isn't always easy given the stigma associated with some neurologic conditions, is a big and brave first step, he says. 'Telling your story has an effect on the person hearing that story. It also has an effect on the person telling the story,' says Smith. 'I wasn't an advocate on day one or day 100. It took me several years. Now it's what makes my life meaningful. The day I stay home is the beginning of the end. I'll rest when I can't get out of bed.'
© 2016 American Academy of Neurology"

I borrowed this from GPACT, because this image is right.



If you want to be an advocate, it is going to take a lot for to work towards it. It means spending a lot of your hours and free time researching things, organizing groups, events, etc. It takes a lot of work but think of all of the people you would be helping who really have no one else to turn to. I hope this article spoke with you, like it did with me.