enviva is a Phase 2 clinical research study. The goal of enviva is to explore the effect of an investigational drug on the symptoms of irritable bowel syndrome with predominant diarrhea (IBS-D). Researchers are studying how the investigational drug may help ease unpleasant symptoms, such as abdominal pain, bloating, and altered stool consistency.
Study participants may be able to join the study if they meet the following requirements:
18 years of age or older
Confirmed diagnosis of IBS-D
Have no expected changes to their lifestyle, exercise routine, and/or diet during study participation
Are willing to complete a daily diary of symptoms through a mobile app
Other study requirements will apply.
Participation in the enviva study lasts about lasts about 19 weeks. Study participants can expect the following:
Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.
Take the pre-screener to see if you may qualify!
Take the Pre-ScreenerThe investigational drug, CIN-103, is a new formulation of a gastrointestinal drug called phloroglucinol. Phloroglucinol is used outside of the United States to relieve painful spasms within the GI tract. The investigational drug is designed to work similarly to help relieve symptoms of pain, cramping, and diarrhea by treating the painful spasms that occur in the GI tract.
Participants are randomly assigned to a dose that may include either the investigational drug, a matching placebo, or a combination of the two.
Investigational means the study medication is not approved by regulatory authorities like the US Food and Drug Administration (FDA), and it can only be used in clinical research studies like enviva.
Irritable Bowel Syndrome is a collection of symptoms that appear together without the presence of damage or disease to the digestive tract. Individuals with IBS experience abdominal pain and changes to their bowel movements that include diarrhea, constipation, or both.
It is estimated that about 12% of the US population suffers from IBS. Factors that increase the likelihood of developing IBS include a family history of IBS, a history of stressful life events, and severe infection of the digestive tract.
The subtype of IBS known as Irritable Bowel Syndrome with Persistent Diarrhea (IBS-D) is defined by abnormal bowel movement where more than a quarter of stools are loose and watery.
Current therapy options include prescription medications, stress management, and dietary supplements. Enviva is researching an investigational drug that works differently than currently approved medications and has potential to help relieve unpleasant symptoms.
National Institute of Diabetes and Digestive and Kidney Diseases. (2017). Definition & Facts for Irritable Bowel Syndrome. U.S. Department of Health and Human Services, National Institutes of Health. Retrieved November 10, 2023, from Definition & Facts for Irritable Bowel Syndrome - NIDDK (nih.gov).
Here are some common questions and answers about study participation.
Clinical research studies, or trials, help scientists and doctors explore whether a medical strategy, device, or medication is safe and effective for people. Before any medication can be approved and made available to the public, it must go through several phases of clinical research.
Before enrolling in a clinical trial, you must sign an Informed Consent Form (ICF). The ICF contains information about the study, including study goals, how long the study will last, benefits and risks, and the tests and procedures you will receive.
Study participation usually involves visiting a clinic regularly, taking or receiving an investigational medicine, and having assessments to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a study.
Participation in clinical research studies is your choice, and you may stop at any time.
If you have additional questions about participating in a clinical research study, contact a study clinic near you.
Use the filters, map, and listing to find the study clinic closest to you. Contact the study clinic to learn more.