The Probiotic Study: Using Bacteria to Calm Your Mind

Completed · Phase 2

Conditions studied: Anxiety, Abdominal Pain

In brief

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.

Key facts

Study ID

NCT02711800

Run by

Nancy Zucker

People needed

9

Starts

2016-11-08

Expected to finish

2017-09-18

Last updated by the study team

2026-06-10

Who can join

Age: 9 and older, up to 13. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants need to meet the criteria for functional abdominal pain as specified by the Rome III:
• Scenario #1 Criteria for inclusion
• 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)
• 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.

You may not qualify if…

• Participants with immune disorders will be automatically excluded from this study.

Where it is running

• Duke Center for Developmental Epedimiology — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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