Clinical trial NCT02711800: The Probiotic Study: Using Bacteria to Calm Your Mind
Official title: Probiotic Treatment: The Role of the Gut Microbiome in Childhood Abdominal Pain and Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anxiety
Abdominal Pain
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-03-17
Enrollment: 9
Sex: ALL
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Change in Child Abdominal Pain Rating
timeFrame: One week pre-intervention (Study Day 1), One week post-intervention (Study Day 44)
measure: Change in Child Abdominal Pain Frequency
timeFrame: One week pre-intervention (Study Day 1), One week post-intervention (Study Day 44)
measure: Change in Child Anxiety Symptoms
timeFrame: Baseline and 30 days
Secondary outcomes:
measure: Percentage of Adherence to Treatment
timeFrame: 30 days
measure: Change in Relative Quantities of Taxa Among Groups Relative to Probiotic Administration
timeFrame: Baseline and 30 days
measure: Change in Alpha Diversity
timeFrame: Baseline and 30 days
measure: Change in Beta Diversity (PCoA)
timeFrame: Baseline and 30 days
measure: Change in Trait-associated Co-functional Modules of Organisms
timeFrame: Baseline and 30 days
measure: Change in Salivary Cortisol (ug/dL)
timeFrame: Baseline and 30 days
measure: Change in Heart Rate
timeFrame: Baseline and 30 days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Center for Developmental Epedimiology
state: North Carolina
Study officials:
affiliation: Duke University
name: Nancy Zucker, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. doi: 10.1111/j.2044-8260.1992.tb00997.x.