Recruiting

Probiotic Supplement

Sponsor:

Acadia University

Code:

NCT02545634

Conditions

Attention Deficit Hyperactivity Disorder

Anxiety

Eligibility Criteria

Sex: All

Age: 6 - 14

Healthy Volunteers: Not accepted

Interventions

L. helveticus R0052 and B. longum R0175

Placebo

Study Details

Brief 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.

Conditions

Attention Deficit Hyperactivity Disorder

Anxiety

Study ID

NCT02545634

Start date

Jun, 2015

Status verified date

Sep, 2015

Completion date

Jun, 2016

Anticipated

Primary completion date

May, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 14

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • average score of 2.5 or higher on either the hyperactive/impulsive or inattentive symptoms on eligibility questionnaire
  • total score of 10 or higher on the anxiety eligibility questionnaire

Exclusion Criteria:

  • Dairy or Soy allergy
  • Currently taking antibiotics
  • HIV/AIDS
  • Diagnosis of Cancer, Crohn's Disease, or Ulcerative Colitis
  • Undergoing chemotherapy

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: Placebo powder

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.

experimental: Probiotic powder

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.

Interventions

L. helveticus R0052 and B. longum R0175

See arm descriptions for intervention description.

Placebo

Primary outcome measure

  • Change in ADHD-specific items of the Child Disruptive Behavior Disorders Scale [ Time Frame: First day of study participation and again at weeks 4, 8, and 12 ]

Central Contacts and Locations

Central contacts

Susan Potter, Phd.

902-585-1220susan.potter@acadiau.ca

Patrick Bazinet, BAh

9027903548bazinet.patrick@gmail.com

Locations

Acadia University

Recruiting

Wolfville, Nova Scotia, Canada, B4P 2R6

Contacts

Susan Potter, Phd.

902-585-1220susan.potter@acadiau.ca

Patrick Bazinet, BAh

9027903548bazinet.patrick@gmail.com

More Information

Sponsor

Acadia University

Last update posted

Sep 10, 2015

Last verified

Sep, 2015

Keywords

  • probiotic
  • ADHD
  • anxiety
  • digestive health
  • children
  • attention deficit
  • gut brain axis
  • nutritional supplement
  • microbiome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Acadia University on 2015-09-10.