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.