Phase 2 N=9 Treatment

The Probiotic Study: Using Bacteria to Calm Your Mind

Anxiety · Abdominal Pain

Bottom Line

View on ClinicalTrials.gov: NCT02711800 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2019

Primary outcome: Primary: Change in Child Abdominal Pain Rating — 0.36 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Lactobacillus rhamnosus (Drug)
Age: Pediatric · 9+ yrs
Sex: All
Sponsor: Nancy Zucker
Primary completion: Sep 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Child Abdominal Pain Rating	0.36	—
PRIMARY Change in Child Abdominal Pain Frequency	0.40	—
PRIMARY Change in Child Anxiety Symptoms	1.30	—
SECONDARY Percentage of Adherence to Treatment	91	—
SECONDARY Change in Relative Quantities of Taxa Among Groups Relative to Probiotic Administration	—	—
SECONDARY Change in Alpha Diversity	—	—
SECONDARY Change in Beta Diversity (PCoA)	—	—
SECONDARY Change in Trait-associated Co-functional Modules of Organisms	—	—
SECONDARY Change in Salivary Cortisol (ug/dL)	-0.02	—
SECONDARY Change in Heart Rate	0.825	—

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

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.

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02711800). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.