The Probiotic Study: Using Bacteria to Calm Your Mind

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02711800
• Other study ID #: Pro00063870
• Status: Completed
• Phase: Phase 2
• Start date: November 8, 2016
• Est. completion date: September 18, 2017

Study information

• Verified date: December 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 18, 2017
• Est. primary completion date: September 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Pain
• Anxiety

Intervention

Drug:
• Lactobacillus rhamnosus
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.

Locations

Country	Name	City	State
United States	Duke Center for Developmental Epedimiology	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Nancy Zucker

Country where clinical trial is conducted

United States, 

References & 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 ( Pt 3):301-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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.	30 days
Secondary	Change in Relative Quantities of Taxa Among Groups Relative to Probiotic Administration		Baseline and 30 days
Secondary	Change in Alpha Diversity		Baseline and 30 days
Secondary	Change in Beta Diversity (PCoA)		Baseline and 30 days
Secondary	Change in Trait-associated Co-functional Modules of Organisms		Baseline and 30 days
Secondary	Change in Salivary Cortisol (ug/dL)		Baseline and 30 days
Secondary	Change in Heart Rate	Beats per minute (Bpm)	Baseline and 30 days