The Probiotic Study: Using Bacteria to Calm Your Mind
Condition: Anxiety; Abdominal Pain
MeSH terms: Abdominal Pain
Intervention: Lactobacillus rhamnosus
Intervention description: The investigators will use Culturelle®, a probiotic composed of the micro-organisms Lactobacillus GG. This formulation has been used for the treatment of gastrointestinal inflammation in numerous clinical trials. Dosing will follow the manufacturer's recommendation for children (1 capsule/packet per day), and will be monitored by the study Co-PI, Dr. Seed. Weekly side effects and clinical changes will be monitored by both study therapist and caregiver using the Children's Global Assessment Scale and the Clinical Global Impression Scale (Severity, Improvement, and Efficacy). The treatment duration is 30 days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 9 Years
Maximum age: 13 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

        Participants need to meet the criteria for functional abdominal pain as specified by the
        Rome III:

        Scenario #1 Criteria for inclusion

          1. In the last 2 months, how often did the child have pain or an uncomfortable feeling in
             the upper abdomen above the belly button? If ≥ 8 (or if the combination of #1 and #2
             is ≥8)

          2. In the last 2 months, how often did the child have pain or an uncomfortable feeling in
             the upper abdomen below the belly button? If ≥ 8 (or if the combination of #1 and #2
             is ≥8)

        Scenario #2 Criteria for inclusion 3. In the last 2 months, when the child hurt or felt
        uncomfortable above (below) the belly button, how often did your child miss school or stop
        activities? If #1 and #2 is ≥ 2 (or if the combination of #1 and #2 is ≥2) and #3 is ≥ 25%
        of the time.

        They also have to be at or above cutoff (i.e. TS>= 55) for Beck Youth Inventory (BYI) which
        can be determined by finding the corresponding raw score, gender, and age on Appendix A in
        the BYI manual.

        Exclusion Criteria:

        1. Participants with immune disorders will be automatically excluded from this study.