NCT02711800

The Probiotic Study: Using Bacteria to Calm Your Mind

Completed Phase 2 Results posted Last updated 3 January 2019

What this trial tests

Phase 2 trial testing Lactobacillus rhamnosus in Anxiety in 9 participants. Completed in 18 September 2017.

Timeline

8 November 2016

Primary endpoint
18 September 2017

18 September 2017

Quick facts

Lead sponsor	Nancy Zucker
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	8 November 2016
Primary completion	18 September 2017
Estimated completion	18 September 2017
Sites	1 location across United States

Drugs / interventions tested

• Lactobacillus rhamnosus — full drug profile →

Conditions studied

• Anxiety — all drugs for Anxiety →
• Abdominal Pain — all drugs for Abdominal Pain →

Sponsor

Nancy Zucker

Who can join

Adults 9 to 13, any sex, with Anxiety or Abdominal Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Child Abdominal Pain Rating Primary · 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.

Group	Value	95% CI
Lactobacillus Rhamnosus	0.36	± 0.58

Change in Child Abdominal Pain Frequency Primary · 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

Group	Value	95% CI
Lactobacillus Rhamnosus	0.40	± 0.61

Change in Child Anxiety Symptoms Primary · 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.

Group	Value	95% CI
Lactobacillus Rhamnosus	1.30	± 3.91

Percentage of Adherence to Treatment Secondary · 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.

Group	Value	95% CI
Lactobacillus Rhamnosus	91	77 – 100

Change in Salivary Cortisol (ug/dL) Secondary · Baseline and 30 days

Group	Value	95% CI
Lactobacillus Rhamnosus	-0.02	± 0.06

Change in Heart Rate Secondary · Baseline and 30 days

Beats per minute (Bpm)

Group	Value	95% CI
Lactobacillus Rhamnosus	0.825	± 6.056

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mechanisms and Clinical Implications of Human Gut Microbiota-Drug Interactions in the Precision Medicine Era.
   Wang S, Ju D, Zeng X. · · 2024 · cited 25× · PMID 38255298 · DOI 10.3390/biomedicines12010194
2. Does the Gut Microbial Metabolome Really Matter? The Connection between GUT Metabolome and Neurological Disorders.
   Marć MA, Jastrząb R, Mytych J. · · 2022 · cited 18× · PMID 36235622 · DOI 10.3390/nu14193967