Trial record 2 of 6 for:    autism UC Davis

Effect of Milk Oligosaccharides and Bifidobacteria on the Intestinal Microflora of Children With Autism

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of California, Davis
Sponsor:
Information provided by (Responsible Party):
Kathleen Angkustsiri, MD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT02086110
First received: March 7, 2014
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to determine the tolerability of dietary supplements and if these supplements can promote a healthy bacterial environment in the intestines of children with autism spectrum disorders and gastrointestinal complaints.


Condition Intervention Phase
Autism
Dietary Supplement: Synbiotic
Dietary Supplement: Prebiotic
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: A Pilot Study Examining Microbiota Composition in Children With Autism and Gastrointestinal Symptoms After Use of Bifidobacterium Infantis and Milk Oligosaccharides

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Stool Microbiota Composition [ Time Frame: Five weeks ] [ Designated as safety issue: No ]
    The stool microbiome composition will be analyzed through next generation sequencing and quantitative polymerase chain reaction. Both the overall bacterial composition will be analyzed as well as specific Bifidobacteria species present.


Secondary Outcome Measures:
  • Serum Immune Profile [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    Luminex technology will be used to determine a serum immune profile of each participants in response to the study supplement. This profile will include pro-inflammatory cytokines (IFNg, IL-1, IL-6, IL-13 and TNFa) and anti-inflammatory cytokines (IL-10 and TGFb1).

  • Serum Immunoglobin Level [ Time Frame: Five weeks ] [ Designated as safety issue: No ]
    An ELISA (enzyme-linked immunosorbent assay) will be used to determine participants' immunoglobulin (Ig) levels (IgA, IgG and IgM) in response to the study supplement.


Estimated Enrollment: 10
Study Start Date: February 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prebiotic first
This group will receive bovine milk oligosaccharides, administered orally twice per day for a daily total of 0.3 g per pound of body weight.
Dietary Supplement: Synbiotic
Other Names:
  • Bifidobacterium infantis SC268
  • bovine colostrum, bovine oligosaccharides
Dietary Supplement: Prebiotic
Other Name: bovine colostrum, bovine oligosaccharides
Active Comparator: Synbiotic first
This group will receive Bifidobacterium infantis (10 billion CFU) twice a day plus 0.3 g per pound body weight of bovine milk oligosaccharides in two divided doses per day orally.
Dietary Supplement: Synbiotic
Other Names:
  • Bifidobacterium infantis SC268
  • bovine colostrum, bovine oligosaccharides
Dietary Supplement: Prebiotic
Other Name: bovine colostrum, bovine oligosaccharides

Detailed Description:

This study investigates the feasibility, tolerability, and effects of a dietary supplement on the intestinal flora of children with autism spectrum disorders. This study is divided into two parts, each five weeks long, with a two week break in between. During one part of the study, a prebiotic (milk oligosaccharides from bovine colostrum) will be given. During the other part of the study, the synbiotic composed of the prebiotic and probiotic (bifidobacterium infantis) will be given. Stool will be analyzed at the end of each study arm to determine content of bifidobacteria.

  Eligibility

Ages Eligible for Study:   2 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Autism
  • Diarrhea and/or constipation

Exclusion Criteria:

  • Milk protein or other documented food allergy
  • Lactose intolerance
  • Compromised Immunity
  • GI conditions (inflammatory bowel disease, celiac disease, short gut, etc.)
  • Systemic steroid, antifungal, or antibiotic use within a month of starting the study
  • Failure to thrive
  • Medically prescribed diets or supplements (including probiotic use within the past month).
  • Vegetarian or dairy restricted diet
  • Other medical conditions (seizures, genetic disorders, liver/pancreatic disease, cystic fibrosis, etc.)
  • Medications that interfere or alter intestinal motility or microbiota composition.
  • Full scale intelligence quotient (IQ) <40
  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: NCT02086110

Contacts
Contact: Jonathan Polussa, BS 916.703.0477 jonathan.polussa@ucdmc.ucdavis.edu

Locations
United States, California
UC Davis MIND Institute Recruiting
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Kathleen Angkustsiri, MD UC Davis MIND Institute
  More Information

No publications provided

Responsible Party: Kathleen Angkustsiri, MD, Assistant Professor, University of California, Davis
ClinicalTrials.gov Identifier: NCT02086110     History of Changes
Other Study ID Numbers: 450072
Study First Received: March 7, 2014
Last Updated: March 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
probiotic
prebiotic
autism
oligosaccharides
Bifidobacterium infantis

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on October 01, 2014