SB-121 Probiotic Study for Teens and Adults With Autism

Why are we doing this research?

Cincinnati Children’s is conducting a research study, sometimes known as clinical trial or clinical study, to learn about the safety of a new liquid probiotic supplement mixture - SB-121 - in teens and adults with autism. We also want to learn how well the body manages (tolerates) and responds to the medicine with a possible improvement in behavioral and GI disorders.

Who can participate?

Teens and adults 15 to 45 years old who have been diagnosed with autism may be eligible to participate.

Conditions

  • Autism

What will happen in the study?

Throughout this study information, “your child” refers to either your child or dependent.

We want you to know that it is safe to come to Cincinnati Children’s during the coronavirus pandemic. We are taking every precaution to protect your child and you while you are at the medical center.

Participation in this study involves up to 5 study visits at Cincinnati Children’s and phone calls to check on your child’s healthy or your health, if the participant, over a period of 10 to 14 weeks. Here are some things that will happen in this study.

We will:

  • Ask you about your child’s medical history, or your medical history, if you are the participant
  • Take vital signs and complete a physical
  • Complete an electrocardiogram (ECG), a test to see how the heart is working
  • Collect blood, urine and stool samples
  • Provide you with 27 doses of the study drug for your child or you, if the study participant, to take daily
  • Complete questionnaires/assessments for cognition, emotions, motor skills, and sensation
  • Contact you by phone and/or video call each week between your visits to ask about any side effects, illnesses, or problems your child or you may have experienced since we last spoke to you

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 will be sure that all of your questions are answered.

What are the good things that can happen from this research?

We cannot promise any benefits to your child, or you, if the participant, or others from your taking part in this research. However, it is possible that your child or you may feel better or it might help to reduce autism symptoms. When the study is completed, the study doctors expect to know more about SB-121 and autism. Overall, your participation in this study may help others with autism in the future.

What are the bad things that can happen from this research?

Possible risks and discomforts will be discussed with you prior to the start of the study and include stomach discomfort/pain or cramps, nausea, vomiting, constipation and diarrhea.

Will you/your child be paid to be in this research study?

Participants will receive up to $1,400 for your time and effort.

Contact

Contact Us.Lily Barber
513-636-9066
lillian.barber@cchmc.org
Cincinnati Children’s Hospital Medical Center
3333 Burnet Ave.
Cincinnati, OH 45229-3039

Study Doctor

Contact Us.Craig Erickson, MD
Psychiatry
Cincinnati Children’s Hospital Medical Center