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Probiotic

Probiotic powder for Anxiety

Phase 4
Waitlist Available
Led By Susan Potter, Phd.
Research Sponsored by Acadia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first day of study participation and again at weeks 4, 8, and 12
Awards & highlights

Study Summary

The study will examine the effect of a probiotic supplement (Lactobacillus helveticus R0052 and Bifidobacterium Longum R0175) dissolved in a dairy product such as milk or ice-cream on symptoms of ADHD and anxiety in children. The main goal is to determine if probiotics might be useful as a treatment for anxiety and ADHD symptoms in children. A second goal is to examine the effects of probiotics on saliva cortisol levels. Finally, the investigators are also interested in the effects of the probiotics on children's digestive health.

Eligible Conditions
  • Attention Deficit Hyperactivity Disorder (ADHD)
  • Anxiety

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first day of study participation and again at weeks 4, 8, and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and first day of study participation and again at weeks 4, 8, and 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in ADHD-specific items of the Child Disruptive Behavior Disorders Scale
Secondary outcome measures
Change in Salivary cortisol
Change in Visual Memory Test
Change in Word Pairs Memory Test
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Probiotic powderExperimental Treatment1 Intervention
The Investigational Product is formulated with a combination of two active ingredients: L. helveticus R0052 and B. longum R0175 and the percentage of each strain is 90% and 10% respectively. The minimum total count of L. helveticus R0052 and B. longum R0175 is 3 x 109 colony forming units (CFU) per stick during the shelf-life. The IP also contains the following excipients: xylitol (sweetener), maltodextrin (coating agent), fruit flavor and malic acid (acidity regulator). The total weight is 1.5 g per stick. All participants will consume the placebo for 28 days during one of two dosing phases.
Group II: Placebo powderPlacebo Group1 Intervention
Placebo powder contains the same ingredients as the probiotic powder except the L. helveticus R0052 and B. longum R0175. All participants will consume the placebo for 28 days during one of two dosing phases.

Find a Location

Who is running the clinical trial?

Lallemand Health SolutionsIndustry Sponsor
39 Previous Clinical Trials
3,619 Total Patients Enrolled
Acadia UniversityLead Sponsor
1 Previous Clinical Trials
75 Total Patients Enrolled
1 Trials studying Anxiety
75 Patients Enrolled for Anxiety
Susan Potter, Phd.Principal InvestigatorAcadia University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Effects of a Probiotic Supplement on Symptoms of Attention Deficit Hyperactivity Disorder and Anxiety in Children
2015. "Effects of a Probiotic Supplement on Symptoms of Attention Deficit Hyperactivity Disorder and Anxiety in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02545634.
All > Anxiety
~10 spots leftby Apr 2025
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