Trial record 2 of 27 for:    ACADIA

Effects of a Probiotic Supplement on Symptoms of Attention Deficit Hyperactivity Disorder and Anxiety in Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by Acadia University
Sponsor:
Collaborator:
Lallemand Health Solutions
Information provided by (Responsible Party):
Acadia University
ClinicalTrials.gov Identifier:
NCT02545634
First received: July 30, 2015
Last updated: September 8, 2015
Last verified: September 2015
  Purpose
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.

Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Anxiety
Dietary Supplement: L. helveticus R0052 and B. longum R0175
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of a Probiotic Supplement on Symptoms of ADHD and Anxiety in Children

Resource links provided by NLM:


Further study details as provided by Acadia University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Salivary cortisol [ Time Frame: First day of study participation and again at weeks 4, 8, and 12 ] [ Designated as safety issue: No ]
  • Change in total score on the Screen for Child Anxiety Related Emotional Disorders [ Time Frame: First day of study participation and again at weeks 4, 8, and 12 ] [ Designated as safety issue: No ]
  • Change in Word Pairs Memory Test [ Time Frame: First day of study participation and again at weeks 4, 8, and 12 ] [ Designated as safety issue: No ]
  • Change in Visual Memory Test [ Time Frame: First day of study participation and again at weeks 4, 8, and 12 ] [ Designated as safety issue: No ]
  • Change in total omission and commission errors on the Continuous Performance Task [ Time Frame: First day of study participation and again at weeks 4, 8, and 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2015
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Placebo
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.
Dietary Supplement: L. helveticus R0052 and B. longum R0175
See arm descriptions for intervention description.
Other Names:
  • Probiostick
  • Jamieson Probiotic Sticks
  • Health Canada Natural Product Number (NPN) 80021343

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years to 14 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02545634

Contacts
Contact: Susan Potter, Phd. 902-585-1220 susan.potter@acadiau.ca
Contact: Patrick Bazinet, BAh 9027903548 bazinet.patrick@gmail.com

Locations
Canada, Nova Scotia
Acadia University Recruiting
Wolfville, Nova Scotia, Canada, B4P 2R6
Contact: Susan Potter, Phd.    902-585-1220    susan.potter@acadiau.ca   
Contact: Patrick Bazinet, BAh    9027903548    bazinet.patrick@gmail.com   
Sponsors and Collaborators
Acadia University
Lallemand Health Solutions
Investigators
Principal Investigator: Susan Potter, Phd. Acadia University
  More Information

Responsible Party: Acadia University
ClinicalTrials.gov Identifier: NCT02545634     History of Changes
Other Study ID Numbers: APB-C1 
Study First Received: July 30, 2015
Last Updated: September 8, 2015
Health Authority: Canada: Health Canada

Keywords provided by Acadia University:
probiotic
ADHD
anxiety
digestive health
children
attention deficit
gut brain axis
nutritional supplement
microbiome

Additional relevant MeSH terms:
Anxiety Disorders
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sulfalene
Anti-Infective Agents
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on July 21, 2016