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The Probiotic Study: Using Bacteria to Calm Your Mind

Anxiety Clinical Trial

Official title:
Probiotic Treatment: The Role of the Gut Microbiome in Childhood Abdominal Pain and Anxiety

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02711800
Study type Interventional
Source Duke University
Contact
Status Completed
Phase Phase 2
Start date November 8, 2016
Completion date September 18, 2017
View Details
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