The Probiotic Study: Using Bacteria to Calm Your Mind
Status:
Completed
Trial end date:
2017-09-18
Target enrollment:
Participant gender:
Summary
The investigators seek to conduct the first open-label trial of probiotics in young children
to reduce their anxiety and abdominal pain. Likewise, the investigators aim to assess the
feasibility and efficacy of this treatment and to elucidate the enteric microbiota in the
middle-lower GI tract. Self-report measures and a laboratory task will be collected from
children, ages 9-13 years of age, and self-report measures from their primary caregivers
prior to and following a 30-day probiotic administration. Children who score above cutoff in
anxiety and/or abdominal pain meet the inclusion criteria for this study. Because of limited
sample size and the iterative nature of intervention development, criteria for success at the
pilot phase are based primarily on clinical rather than statistical criteria. The study
personnel will do their best to keep and ensure the privacy and confidentiality of our
participants; however, some of the risks of this study may include psychological discomfort,
legal risks, and loss of confidentially.