Participate in Research and Clinical Trials
If you wish to receive information about openly recruiting research studies, please sign up HERE to receive an email any time new studies become available.
Cause of Symptom Studies
None at the moment. Please check back soon!
Diabetic Gastroparesis Research Study
- Research Coordinator: Ariel Watts
- (919) 843-0821
Do you have Diabetic Gastroparesis? (i.e. : nausea, abdominal pain, post-prandial fullness, bloating, vomiting, and early satiety)
If you are at least 18 years of age and currently suffering from symptoms of Diabetic Gastroparesis, you may be eligible for a research study involving an investigational drug to help reduce these symptoms. Study participation could last as long as 12-weeks. Compensation may be included for eligible participants.
If you are interested in learning more about this study, please call (919) 843-0821 or email Ariel_Watts@med.unc.edu.
This is sponsored by UNC Center for Esophageal Diseases and Swallowing.
Accidental Bowel Leakage Study
“FIT Study” Comparative Effectiveness of biofeedback, sacral nerve stimulation, and injectable bulking agents for the treatment of fecal incontinence.
- There are four recruiting sites for this research study.
- University of North Carolina at Chapel Hill
- Mayo Clinic Rochester: Rochester, Minnesota
- Colon and Rectal Surgery Associates: Saint Paul, Minnesota
- Augusta University Medical College of Georgia: Augusta Georgia
Do you have accidental bowel leakage (ABL), also known as fecal incontinence (FI)? Are you seeking treatment for this?
We are actively recruiting patients in a National Institute of Health (NIH) research study comparing how well three FDA approved treatments work, the safety of each treatment, and the cost of each treatment. The study lasts two years. You may be eligible to participate in this research study if you are over 18 years old, are able to walk on a flat surface independently or with a cane or walker, and have two or more episodes of solid or liquid fecal incontinence per week.
Some reasons that you may not be eligible to participate in this study include; if you have dementia, third or fourth degree obstetrical tears in the past six months, severe rectal bleeding, anal fissure, proctitis, fistula, or infection in the anal area in the past six months, are currently pregnant or planning to become pregnant in the next two years, are diagnosed with Crohn’s disease, ulcerative colitis, Parkinson’s disease, multiple sclerosis, severe diabetic neuropathy, or neurodegenerative disorder. There may be additional medical diagnosis that may exclude you from participation.
The treatments are biofeedback therapy, sacral nerve stimulation, and Solesta injectable bulking agents. Treatments are assigned by chance, so there is no guarantee that you will get a specific treatment. However, if you do not respond to the randomly assigned treatment after three months, you will be able to choose from one of the other treatments.
This two-year study has four stages:
- Baseline: We will collect information about your bowel symptoms by asking you to fill out a two-week paper diary, complete questionnaires in clinic, and take part in diagnostic exams and tests to make sure you meet the criteria to participate in the study. You will not be charged for any of the exams or tests. Some of the diagnostic tests will be repeated after your treatment. If anything is discovered by these tests that would make you ineligible to participate in the study, you will be compensated for your time but excluded from the research study.
- Enhanced medical management: This is a one-month period where a member of our study team will help you reduce incontinence through education, behavioral interventions, and adding medications to normalize your stool consistency. If medical management reduces your incontinence by 75% or more, we will ask you to continue this treatment.
- Randomization: If you do not respond to medical management, you will be randomly assigned to receive biofeedback, sacral nerve stimulation, or injection of Solesta. If your bowel accidents do not decrease adequately after treatment, you can choose a second treatment from one of the other remaining options.
- Follow-Up Visits: You will asked to return to clinic at 3, 6, 12, and 24-months and will be telephoned at 18 months.
You will receive compensation for participation and travel related to the study. For additional information or to see if you are eligible to participate, please contact us today.
ClinicalTrials.gov Identifier: NCT03811821 https://clinicaltrials.gov/ct2/show/NCT03811821