Why are we doing this research?
Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to look at changes in gut bacteria during liver disease progression in the hope this will lead to a better method for chronic liver disease management.
We will compare medical records and test results (from a stool and cheek swab sample) of participants with chronic liver disease to participants who are healthy (called controls).
What will happen in the study?
If your child qualifies for this study and you decide you want them to participate, he or she will have 1 study visit.
The following will be collected during the study:
- Medical information:weight, height, feeding history, antibiotic usage history
- Demographic information:age, race and gender
- Stool sample:used to study intestinal bacterial populations
- Cheek swab sample: used to study oral bacteria and its relationship with changes of the gut bacteria
All of your child’s collected samples will be de-identified. This means the samples will be given a unique identification code that removes any information from them that could match them to your child. The identification code will be recorded into a master list. The master list will only be available to a very small group of individuals involved in this research.
You will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and/or your child and will be sure that all of your questions are answered.
What are the bad things that can happen from this research?
Some people do not want information from their child’s medical records used for research. If you feel this way, your child should not be in this study.
The stool sample collection will cause your child minimal distress and no risk, pain or discomfort. The cheek swab collection will cause your child minimal to no distress, risk, pain or discomfort.
Possible risks and side effects will be provided to and discussed with those parents, legal guardians and participants interested in knowing more about this study.