Lactose Intolerance (Closed)

ClinPoint Trials is seeking individuals with symptoms of lactose intolerance to participate in a clinical research study. 

Giving up dairy can be hard. People with lactose intolerance may have to give up consuming dairy to avoid symptoms such as stomach pain, cramps, bloating, gas movement, release of gas, and diarrhea. Lactose intolerance happens when your body cannot process the sugar in milk (lactose). Lactose intolerance is fairly common - it affects over 40 million people in the United States.

The Liberatus Study aims to find out how well an investigational medication works to improve the symptoms of lactose intolerance (your ability to eat lactose containing foods, like dairy, without discomfort) compared to placebo.

You may qualify for this study if you:

  • Are 18-75 years of age

  • Have a current or recent history of intolerance to milk and other dairy products for at least 1 month

  • Have no other gastrointestinal disorders that could interfere with the study, including Crohn's disease, irritable bowel syndrome, inflammatory bowel disease, ulcerative colitis, Celiac disease or chronic constipation

  • Agree to stop taking all other treatments and products used for lactose intolerance (e.g. Lactaid®, dietary supplements, herbal remedies) throughout the course of the study

  • Agree to abstain from consuming dairy products during certain days of the study and to include dairy products at other times

  • Are willing to complete multiple electronic diary questionnaires at specific time points (sometimes daily, sometimes weekly) during the study, which will capture your daily lactose consumption, any symptoms you may experience, questions about how you are doing, etc.

Other criteria may apply to determine if you are eligible. 

Individuals that qualify to participate will receive compensation for their time, travel, and diary compliance (if applicable). 

For more information or to see if you qualify to participate, please visit the Liberatus Study webisite or call the ClinPoint Trials offices at (972) 937-1640 to speak with a Study Coordinator.

About Lactose Intolerance

Lactose intolerance is a common gastrointestinal condition resulting from the body's inability to process lactose, a sugar found in milk or milk-containing products. For those with lactose intolerance, the small intestine does not break down lactose. Instead, the excess lactose goes undigested into the large intestine. Bacteria in the large intestine ferment the undigested lactose, causing gas production and other gastric symptoms such as abdominal pain, cramping, bloating, gas movement, release of gas, and diarrhea.

Currently there are no prescription treatment options for lactose intolerance, but there are over-the-counter medications and supplements that may help to reduce lactose intolerance symptoms for some people.

About Investigational Medications

"Investigational" means that the medication is still being studied and that the U.S. Food and Drug Administration (FDA) does not yet allow it to be sold in the United States. The FDA allows investigational medications to be used only in research and continually monitor the research and development process. 

What You Need to Know about Anemia and Kidney Disease

What is anemia?

Anemia is a medical condition characterized by a short or low supply of red blood cells. Red blood cells are responsible for carrying oxygen from your lungs to the rest of your body. This gives you the energy you need for all sorts of daily activities. 

What are the symptoms of anemia?

There are several symptoms associated with anemia. 

  • Looking pale or feeling tired/low on energy
  • Having a poor appetite
  • Having trouble thinking or difficulty thinking clearly 
  • Experiencing dizziness, headaches, rapid heartbeat or short of breath
  • Feeling depressed

How do you know if you have anemia?

You cannot rely on symptoms alone to know if you have anemia. Not everyone experiences symptoms. A great way to find out if you have anemia is to have your doctor perform a simple blood test to measure your hemoglobin level. This should be done at least once per year. Hemoglobin is the part of the red blood cells that carry oxygen from the lungs to the rest of your body. Low hemoglobin levels often determine a diagnosis of anemia. 

What causes anemia and how do you treat it?

The way anemia is treated depends on what it is caused by, which can vary person to person. If anemia is caused by chronic kidney disease, treatment options usually include drugs called erythropoiesis stimulating agents (ESAs) and extra iron supplementation. ESAs assist in the production of red blood cells and are usually injected under the skin. If you have low iron levels, your body doesn't have adequate resources to make red blood cells. Low iron levels also cause ESAs to not be as effective as they could be. Iron supplements may be provided in pill form or as an infusion directly into a vein. 

What causes someone with chronic kidney disease to get anemia?

The kidneys are responsible for making a very important hormone called erythropoietin (EPO). Hormones act as messengers that help you to stay healthy. EPO drives the body to make red blood cells. Someone with kidney disease doesn't make enough of the EPO hormone. As a result, the red blood cell count drops and anemia is developed. It is an extremely common issue for individuals with kidney disease. Anemia can develop at any stage of kidney disease, and is especially common in individuals that have diabetes, are African-American, have moderate or severe loss of kidney function (stage 3 or 4 chronic kidney disease), have kidney failure (stage 5 kidney disease), or are female. 

Visit with your doctor for more information about anemia and chronic kidney disease.


If you have been diagnosed with anemia due to chronic kidney disease, you may qualify for a clinical research study. Call the ClinPoint Trials offices at (972) 937-1640 for more information. 

Chronic Kidney Disease

ClinPoint Trials is seeking individuals who have been diagnosed with chronic kidney disease for a clinical research study.

You may be eligible to participate in this study if:

  • You are at least 18 years old
  • You have been diagnosed with Chronic Kidney Disease stages 3, 4 or 5

Throughout the course of the study, your health will be closely monitored by the study team and the study doctor. Qualified participants will receive study-related physical exams, lab tests, and investigational study medication or placebo at no cost. Participation is voluntary.

Compensation may be provided for time and travel.

Contact us at (972) 937-1640 for more information.

Post-Herpetic Neuralgia - Pain after Shingles (Closed)

Do you suffer from pain after shingles?

The symptoms of PHN (post-herpetic neuralgia) can be debilitating. The deep burning pain and extreme skin sensitivity can greatly impact the quality of your life. 

ClinPoint Trials is seeking individuals suffering with pain after shingles for a clinical research study.

You may be eligible to participate in this study if:

  • You are at least 18 years old

  • You are suffering with moderate to severe pain after shingles

Throughout the course of the study, your health will be closely monitored by the study team and the study doctor. Qualified participants will receive study-related physical exams, lab tests, and investigational study medication at no cost. Participation is voluntary.

Compensation may be provided for time and travel.

Contact us at (972) 937-1640 for more information.

From the Lab to Your Medicine Cabinet

Understanding Clinical Trials and the Purpose in Participation

By: Marisa Sibley

Originally published in the May/June 2017 issue of Ellis County LIVING Magazine


When I was a child, I struggled with asthma. To help my condition, my doctor gave me an inhaler that contained a preventative asthma medication. It was easy to use and it helped make physical activities easier for me. I was able to play my favorite sports without fearing I wouldn't be able to breathe. This helped give me a better quality of life as a child. I no longer struggle with asthma, but I am thankful that there was a treatment available to help my condition. 

For me it was an asthma medication and in inhaler. For some it may be insulin or a blood sugar monitor. For others it may simply be an over the counter medication for a common cold or a headache. 

All medications of medical devices available for use by the general population are so only because of individuals who were first willing to volunteer to participate in clinical trials. 

Clinical trials are research studies that seek to answer questions about medical treatments, medical devices or medical strategies. All medical treatments and devices start as ideas. Those ideas are then developed and tested in the laboratory. If the research on these new developments is promising and the Food and Drug Administration (FDA) approves further research testing, then the idea may move forward into clinical trials with human volunteers. 

All potential treatments and devices are tested first in Phase 1 trials, which will only assess whether or not the products are safe for human use. If the products show to be generally safe, then the treatments or devices will continue into Phase 2 and 3 trials with larger numbers of volunteers. These trials continue to answer questions about safety, but also begin to assess how well a product works to improve patient outcomes, if it will benefit a patient, or if the product causes unexpected harm. The FDA monitors and reviews the research data on investigational treatments and devices very closely during all phases of clinical trials and can stop the trials at any time. 

After all trials are completed, the FDA may or may not decide to approve a new treatment or device. Only after FDA approval will these ideas turned treatments end up in our medicine cabinets. Research then continues on these treatments or devices after they enter the marketplace. 

There are many reasons why people choose to participate in clinical trials The top reasons include to advance medicine, to help improve the lives of others, to help improve their own medical condition or to supplement their own standard health care. 

If you choose to join a clinical trial, you can expect to first be thoroughly informed about the study, what the study is testing, information about study appointments and procedures, potential risks and benefits, and your role as a participant.The study doctor, also called an Investigator, will assess whether or not you would be eligible to participate in the study. your eligibility may depend on your medical history, medications you are taking, or other diagnostic tests or exams. 

Throughout the course of your participation in a trial, you can expect your health to be monitored very closely by the Investigator and the study team. This is done through a series of visits to the clinical research site before, during and after a study treatment or device is received or used. Since you are a volunteer, your study-related care is provided free of charge. You may also receive compensation for your time and travel. 

Had no one ever participated in clinical trials for asthma, I may not have had access to a medication that helped my condition improve as a child. Clinical trials are the gateway to advancing medical knowledge and patient care for generations to come. Whether you are a healthy person or have a chronic medical condition, you can help to move medicine forward through participation in a clinical trial. It is truly a gift that keeps on giving. 

If you are interested in participating in a clinical trial in the future or would like more information, reach out to your local clinical research site to speak with a member of the study team about how you can get involved. 


Marisa is a Certified Clinical Research Coordinator (CCRC) at ClinPoint Trials, a clinical research site in Waxahachie. Learn more at www.cptrials.com. You can reach her at (972) 937-1640 or marisas@cptrials.com for more information.

POLO Study: Pediatric Irritable Bowel Syndrome with Constipation

Is your child suffering from constipation? And pain?

Children who are constipated may complain of abdominal discomfort or pain, have infrequent bowel movements, and when their bowels do move, it might be hard or painful. 

The POLO Clinical Research Study will evaluate the investigational use in children of a study drug that has already been approved by the FDA to treat adults with symptoms of constipation.

To qualify for the POLO Clinical Research Study, your child must meet these criteria that are consistent with Irritable Bowel Syndrome with Constipation (IBS-C):

  • Be between 7 and 17 years old
  • Have 2 or fewer bowel movements a week and may
    • Actively try to stop their bowel movements or
    • Do what doctors call "retentive posturing". They stand straight, on their toes, or may have a red face as they try to stop their bowel movements.
  • Have abdominal pain or discomfort with bowel movements at least for the past 2 months
  • Otherwise, be in relatively good health

Study participants will receive study-related exams, lab tests, and investigational study drug at no charge. Your child's health will be monitored by the Study Nurse and Doctor. 

If your child participates in the POLO Research Study, he/she will visit ClinPoint Trials approximately 6 times in 12 weeks. The study will last approximately 9-12 weeks. Your child will be asked to complete a simple eDiary two times each day. If your child is not able to complete the eDiary, you can complete the diary for your child instead. The study staff will teach the both of you how to use the study diary. 

Don't miss the boat! Call ClinPoint Trials at (972) 937-1640 or visit www.marco-polostudies.com for more information on the POLO Clinical Research Study.

MARCO Study: Pediatric Functional Constipation (Closed)

Is your child suffering from constipation?

Children who are constipated may complain of abdominal discomfort or pain, have infrequent bowel movements, and when their bowels do move, it might be hard or painful. 

The MARCO Clinical Research Study will evaluate the investigational use in children of a study drug that has already been approved by the FDA to treat adults with symptoms of constipation.

To qualify for the MARCO Clinical Research Study, your child must meet these criteria that are consistent with Functional Constipation (FC):

  • Be between 6 and 17 years old

  • Have 2 or fewer bowel movements a week and may

    • Actively try to stop their bowel movements or

    • Do what doctors call "retentive posturing". They stand straight, on their toes, or may have a red face as they try to stop their bowel movements.

  • Have painful or hard bowel movements

  • Otherwise, be in relatively good health

Study participants will receive study-related exams, lab tests, and investigational study drug at no charge. Your child's health will be monitored by the Study Nurse and Doctor. 

If your child participates in the MARCO Research Study, he/she will visit ClinPoint Trials approximately 6 times in 12 weeks. The study will last approximately 9-12 weeks. Your child will be asked to complete a simple eDiary two times each day. If your child is not able to complete the eDiary, you can complete the diary for your child instead. The study staff will teach the both of you how to use the study diary. 

Don't miss the boat! Call ClinPoint Trials at (972) 937-1640 or visit www.marco-polostudies.com for more information on the MARCO Clinical Research Study.

A Word on Diabetes

Originally published in the ClinPoint Trials November Newsletter – Subscribe here.

According to the American Diabetes Association, diabetes mellitus affects nearly 30 million children and adults in the United States. Another 86 million Americans have pre-diabetes and are at risk for developing type 2 diabetes. For a condition that is so common, many still ask…

What is Diabetes Mellitus?

Diabetes mellitus refers to what is actually a group of diseases that affect how your body processes blood sugar, also known as glucose. Glucose is the brain’s main source of fuel and a very important source of energy for the cells that the body is made up of.

There are several types of diabetes mellitus, including type 1 and 2, pre-diabetes or gestational diabetes. One important factor involved in diabetes mellitus, regardless of the type, is insulin. Insulin is a hormone produced by the pancreas that regulates the amount of glucose allowed to enter the cells of the body. Although the variable types of diabetes mellitus may have different causes, the nature of the diseases is the same; there is too much glucose in the bloodstream, which can lead to serious health problems if not adequately controlled.

Pre-diabetes and Gestational Diabetes

Pre-diabetes is a condition in which blood sugar levels are higher than normal, but not yet high enough for a diagnosis of type 2 diabetes. Gestational diabetes occurs during pregnancy and can be passed onto the newborn baby.

Type 1 Diabetes

In type 1 diabetes, the immune system attacks the cells that produce insulin in the pancreas. In turn, your body is left with little or no insulin, allowing glucose to build up in the bloodstream. The cause of type 1 diabetes is unknown but is thought to be contributed to genetic and environmental factors. Type 1 diabetes appears most often in childhood and is treated primarily by insulin injections.

Type 2 Diabetes

In type 2 diabetes, the cells of the body become resistant to insulin. The pancreas becomes unable to produce enough insulin to overcome the resistance. Therefore, glucose builds up in the bloodstream instead of moving into the cells of the body to be used for energy. The cause of type 2 diabetes is not clearly known, but similar to type 1, genetic and environmental factors are thought to be contributors to the development of the disease. Type 2 diabetes appears most often in adults over the age of 40, although it can develop in younger individuals. It is treated by primarily by monitoring blood sugar, oral medications, insulin injections or both.

Risk Factors

There are several risk factors for the different types of diabetes mellitus. An individual is at an increased risk for developing type 1 diabetes if a parent or sibling has the disease, if there Is a presence of damaging immune system cells, called autoantibodies, or if one is not consuming enough vitamin D. Type 1 diabetes is the only type of disease that cannot be prevented. However, it is often encouraged for individuals to follow similar lifestyle habits of those working to control the other types of diabetes mellitus.

Risk factors for pre-diabetes and type 2 diabetes include excess weight, a sedentary lifestyle, family history, being of African American or Hispanic race, increased age, poor eating habits especially including increased intake of refined carbohydrates and refined sugars, having gestational diabetes while pregnancy and other medical conditions such as PCOS, high blood pressure or high cholesterol or triglycerides.

Gestational diabetes can be developed in any woman that is pregnant, but some women are more at risk than others. Risk factors include increased age, family or person history, being overweight or being of African American or Hispanic race.

Symptoms

Symptoms of diabetes can include increased thirst, frequent urination, extreme hunger, fatigue and irritability, blurred vision or presence of ketones in the urine. If you feel you are experiencing symptoms or feel you may be at risk for diabetes, you should see your doctor. He or she will be able to perform the necessary tests for diagnosis of diabetes mellitus or be able to tell you if you are indeed at risk.

Here is the good news!

Type 2 diabetes and gestational diabetes can be prevented. If you have already been diagnosed, the disease can be reversed. The best prevention measure to take if you are at risk or if you have been diagnosed with diabetes is to embrace healthy eating habits. A healthy diet for anyone is one with increased intake of fruits, vegetables, lean proteins, whole grains and legumes and limited intake of refined carbohydrates (think white bread) and refined sugars (think cookies, cakes and processed foods).  Another prevention measure is making physical activity a part of your daily routine. Exercise helps to lower blood sugar levels by moving sugar into the cells of the body where they are used for fuel. Exercise also increases sensitivity to insulin. Choose activities that you enjoy such as walking, yoga, strength training or dance classes. Both a healthy diet and physical activity can promote the loss of excess weight. If you are overweight, losing even just 7 percent of your body weight can reduce the risk of diabetes and other health conditions.

Remember – it’s not about perfection. Small changes can produce big results!