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Completed

NCT Number: NCT02711800

The Probiotic Study: Using Bacteria to Calm Your Mind

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.

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Key information

Conditions

Anxiety Abdominal Pain Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

9 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Duke Center for Developmental Epedimiology

Durham, North Carolina, 27701, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactobacillus rhamnosus

Drug

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.

Other names: Culturelle Kids

Primary outcomes

  1. Change in Child Abdominal Pain Rating

    Time frame: One week pre-intervention (Study Day 1), One week post-intervention (Study Day 44)

    Child and parent report is used to obtain ratings of pain intensity on a 0-12 scale. A lower score equates to lower pain intensity. Ratings are obtained for a one-week period pre and post intervention, and measured 3 times daily. Pre-treatment assessments took place days 1-7, participants were treated days 8-36, and post-intervention assessments were completed days 37-44. All time points will be averaged and combined across raters (child and parent) resulting in an average pain severity rating pre and post-treatment. The change in this average rating will be assessed as pain severity outcome. This measure was averaged with the pain frequency average score (see Primary Outcome 2) to result in one primary severity/frequency pain rating pre and post treatment. The change in this combined measure is our primary index of change.

  2. Change in Child Abdominal Pain Frequency

    Time frame: One week pre-intervention (Study Day 1), One week post-intervention (Study Day 44)

    Child and parent report is used to obtain ratings of pain frequency, the number of distinct occasions that pain was reported. Frequency was obtained for a one-week period pre and post intervention, and measured 3 times daily during these intervals. During the 30-day intervention, end of day frequencies were made. Pre-treatment assessments took place days 1-7, participants were treated days 8-36, and post-intervention assessments were completed days 37-44. The average number of episodes across these time points will be calculated pre and post treatment. The change in this average frequency from pre to post treatment will be the measure of change.

  3. Change in Child Anxiety Symptoms

    Time frame: Baseline and 30 days

    We report the change in magnitude of self-reported state anxiety derived from summed raw scores obtained through the six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory at baseline and 30 days from baseline. Scores in the scale range from 6-24, with greater scores indicating worse anxiety. We obtained the summed raw scores after reverse scoring items 1, 4 & 5.

Secondary outcomes

  1. Percentage of Adherence to Treatment

    Time frame: 30 days

    Adherence was calculated as: ("the days probiotic was taken"/"total number of days of treatment") x 100, with results ranging from 0% (no probiotics taken at all) to 100% (probiotics taken 30 days out of the 30 day-treatment period). Researcher will subtract the number of pills/packets taken from the total amount.

  2. Log Fold Change in Relative Quantities of Lactobacillus Among Groups Pre-treatment Relative to Post-probiotic Administration

    Time frame: Baseline and 30 days

    Examination of the log fold change in relative quantities of Lactobacillus calculated from fecal samples gathered pre-probiotic administration and post-probiotic administration. Analyses represent the log-fold change from post-treatment - pre-treatment quantities.

  3. Log Fold Change in Alpha Diversity

    Time frame: Baseline and 30 days

    Log Fold Change in the alpha species diversity from pre-treatment (prior to probiotic administration) to post probiotic administration.

  4. Log Fold Change in Beta Diversity

    Time frame: Baseline and 30 days

    An examination of the pre-treatment to post-treatment log fold change in the regional and local changes in species characterized in the microbiome.

  5. Change in Salivary Cortisol (ug/dL)

    Time frame: Baseline and 30 days

    A measure of cortisol based on the analysis of saliva samples collected throughout a Trier Social Stress Test.

  6. Change in Heart Rate

    Time frame: Baseline and 30 days

    Beats per minute (Bpm)

Sponsors and collaborators

Lead sponsor

Nancy Zucker

Other

Registry information

Official study title

Probiotic Treatment: The Role of the Gut Microbiome in Childhood Abdominal Pain and Anxiety

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 17, 2016
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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