The Probiotic Study: Using Bacteria to Calm Your Mind
| Status: | Completed |
|---|---|
| Conditions: | Anxiety, Anxiety, Pain |
| Therapuetic Areas: | Musculoskeletal, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 9 - 13 |
| Updated: | 1/5/2019 |
| Start Date: | November 8, 2016 |
| End Date: | September 18, 2017 |
Probiotic Treatment: The Role of the Gut Microbiome in Childhood Abdominal Pain and Anxiety
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.
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.
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.
We found this trial at
1
site
Durham, North Carolina 27701
Principal Investigator: Nancy Zucker, Ph.D.
Phone: 919-687-4686
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