Back to resultsThe Probiotic Study: Using Bacteria to Calm Your Mind
Primary Purpose
Anxiety, Abdominal Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lactobacillus rhamnosus
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety
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:
1. Participants with immune disorders will be automatically excluded from this study.
Sites / Locations
- Duke Center for Developmental Epedimiology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lactobacillus rhamnosus
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Percentage of Adherence to Treatment
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.
Change in Relative Quantities of Taxa Among Groups Relative to Probiotic Administration
Change in Alpha Diversity
Change in Beta Diversity (PCoA)
Change in Trait-associated Co-functional Modules of Organisms
Change in Salivary Cortisol (ug/dL)
Change in Heart Rate
Beats per minute (Bpm)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02711800
Brief Title
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
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
November 8, 2016 (Actual)
Primary Completion Date
September 18, 2017 (Actual)
Study Completion Date
September 18, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nancy Zucker
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Abdominal Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lactobacillus rhamnosus
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lactobacillus rhamnosus
Other Intervention Name(s)
Culturelle Kids
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Child Abdominal Pain Rating
Description
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.
Time Frame
One week pre-intervention (Study Day 1), One week post-intervention (Study Day 44)
Title
Change in Child Abdominal Pain Frequency
Description
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.
Time Frame
One week pre-intervention (Study Day 1), One week post-intervention (Study Day 44)
Title
Change in Child Anxiety Symptoms
Description
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.
Time Frame
Baseline and 30 days
Secondary Outcome Measure Information:
Title
Percentage of Adherence to Treatment
Description
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.
Time Frame
30 days
Title
Change in Relative Quantities of Taxa Among Groups Relative to Probiotic Administration
Time Frame
Baseline and 30 days
Title
Change in Alpha Diversity
Time Frame
Baseline and 30 days
Title
Change in Beta Diversity (PCoA)
Time Frame
Baseline and 30 days
Title
Change in Trait-associated Co-functional Modules of Organisms
Time Frame
Baseline and 30 days
Title
Change in Salivary Cortisol (ug/dL)
Time Frame
Baseline and 30 days
Title
Change in Heart Rate
Description
Beats per minute (Bpm)
Time Frame
Baseline and 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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:
1. Participants with immune disorders will be automatically excluded from this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Zucker, Ph.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Center for Developmental Epedimiology
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27701
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Given the pilot nature of the study, resulting data may not be appropriate for sharing within a larger data repository. We will change this policy if we learn otherwise.
Citations:
PubMed Identifier
1393159
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. Erratum In: Br J Clin Psychol. 2020 Jun;59(2):276.
Results Reference
background
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The Probiotic Study: Using Bacteria to Calm Your Mind
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