The Probiotic Study: Using Bacteria to Calm Your Mind

NCT02711800 | Completed Phase 2 Results DMC

• 1 other identifier: Pro00063870
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Abdominal Pain

Outcome Measures

Primary Outcomes (3)

• Change in Child Abdominal Pain Rating

  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.

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

• Change in Child Abdominal Pain Frequency

  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.

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

• Change in Child Anxiety Symptoms

  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.

  Baseline and 30 days

Secondary Outcomes (7)

• Percentage of Adherence to Treatment

  30 days

• Change in Relative Quantities of Taxa Among Groups Relative to Probiotic Administration

  Baseline and 30 days

• Change in Alpha Diversity

  Baseline and 30 days

• Change in Beta Diversity (PCoA)

  Baseline and 30 days

• Change in Trait-associated Co-functional Modules of Organisms

  Baseline and 30 days

Study Arms (1)

Lactobacillus rhamnosus

EXPERIMENTAL

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 Dr. Patrick Seed from the department of pediatrics. 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 intervention duration is 30 days.

Drug: Lactobacillus rhamnosus

Interventions

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.

Also known as: Culturelle Kids

Lactobacillus rhamnosus

Eligibility Criteria

• Age: 9 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participants need to meet the criteria for functional abdominal pain as specified by the Rome III:
• 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)
• 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.

Sponsors & Collaborators

• Nancy Zucker: lead

Study Sites (1)

Duke Center for Developmental Epedimiology

Durham, North Carolina, 27701, United States

Location

Related Publications (1)

• 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.

  PMID: 1393159 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Abdominal Pain

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Nancy Zucker
• Organization: Duke University

zucke001@mc.duke.edu

9196680075

Study Officials

• Nancy Zucker, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the Duke Center for Eating Disorders, Associate Professor in the Department of Psychology & Neuroscience

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: March 17, 2016
• Study Start: November 8, 2016
• Primary Completion: September 18, 2017
• Study Completion: September 18, 2017
• Last Updated: January 3, 2019
• Results First Posted: January 3, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)