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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02086110
Recruitment Status : Completed
First Posted : March 13, 2014
Results First Posted : August 1, 2019
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date  ICMJE March 7, 2014
First Posted Date  ICMJE March 13, 2014
Results First Submitted Date  ICMJE May 31, 2019
Results First Posted Date  ICMJE August 1, 2019
Last Update Posted Date August 1, 2019
Actual Study Start Date  ICMJE June 6, 2014
Actual Primary Completion Date November 16, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
  • Stool Microbiota Composition Change During Prebiotic Only Treatment [ Time Frame: Five weeks ]
    The stool microbiome composition will be analyzed through next generation sequencing and quantitative polymerase chain reaction. Overall bacterial composition change is reported here, as change in enterotype from before prebiotic only treatment to after prebiotic treatment, for all subjects. Enterotypes were organized into four categories for analysis: a community high in Prevotella ("Prevotella"), a community high in Bifidobacterium ("Bifidobacterium"), a community high in Bacteroides ("Bacteroides"), and a mixed community ("Mixed") that did not fall into one of the other three enterotypes but instead consisted of a varied combination of bacteria, including among others Akkermansia, Collinsela, Prevotella, and/or Bacteroides.
  • Stool Microbiota Composition Change During Synbiotic Treatment [ Time Frame: Five weeks ]
    The stool microbiome composition will be analyzed through next generation sequencing and quantitative polymerase chain reaction. Overall bacterial composition change is reported here, as change in enterotype from before synbiotic treatment to after synbiotic treatment, for all subjects. Enterotypes were organized into four categories for analysis: a community high in Prevotella ("Prevotella"), a community high in Bifidobacterium ("Bifidobacterium"), a community high in Bacteroides ("Bacteroides"), and a mixed community ("Mixed") that did not fall into one of the other three enterotypes but instead consisted of a varied combination of bacteria, including among others Akkermansia, Collinsela, Prevotella, and/or Bacteroides.
Original Primary Outcome Measures  ICMJE
 (submitted: March 11, 2014)
Stool Microbiota Composition [ Time Frame: Five weeks ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
Serum Immune Profile Change During Prebiotic Only Treatment [ Time Frame: Five weeks ]
Luminex technology will be used to determine a serum immune profile of each participants in response to the study supplement. This profile included assessment of change in percentage of stimulated CD4+ T cells producing intracellular IL-13 before and after Synbiotic treatment ("Post-Synbiotic % IL-13"), and assessment of change in percentage of stimulated CD8+ T cells producing TNF-alpha before and after Prebiotic Only treatment ("Post-Prebiotic % TNF-alpha"). Results are reported here for all subjects regardless of treatment order assignment. Decrease in inflammatory cytokines IL-13 and TNF-alpha is interpreted as a positive outcome.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2014)
  • Serum Immune Profile [ Time Frame: 5 weeks ]
    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 ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Milk Oligosaccharides and Bifidobacteria on the Intestinal Microflora of Children With Autism
Official Title  ICMJE A Pilot Study Examining Microbiota Composition in Children With Autism and Gastrointestinal Symptoms After Use of Bifidobacterium Infantis and Milk Oligosaccharides
Brief Summary 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.
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.

On May 8, 2018, we updated the study start and completion dates to the actual (instead of anticipated) dates.

On May 30-31, 2019, we updated the study results section.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Autism
Intervention  ICMJE
  • Dietary Supplement: Synbiotic
    Other Names:
    • Bifidobacterium infantis SC268
    • bovine colostrum, bovine oligosaccharides
  • Dietary Supplement: Prebiotic
    Other Name: bovine colostrum, bovine oligosaccharides
Study Arms  ICMJE
  • Active Comparator: Prebiotic only first, then synbiotic
    This group will receive prebiotic only (bovine milk oligosaccharides, administered orally twice per day for a daily total of 0.3 g per pound of body weight) for the first five weeks, followed by a two week break with no treatment, and then will receive the synbiotic (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) for the next five weeks.
    Interventions:
    • Dietary Supplement: Synbiotic
    • Dietary Supplement: Prebiotic
  • Active Comparator: Synbiotic first, then prebiotic only
    This group will receive the synbiotic (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) for the first five weeks, followed by a two week break with no treatment, and then will receive the prebiotic only (bovine milk oligosacharrides, administered orally twice per day for a daily total of 0.3 g per pound of body weight) for the next five weeks.
    Interventions:
    • Dietary Supplement: Synbiotic
    • Dietary Supplement: Prebiotic
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 31, 2019)
11
Original Estimated Enrollment  ICMJE
 (submitted: March 11, 2014)
10
Actual Study Completion Date  ICMJE November 16, 2015
Actual Primary Completion Date November 16, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02086110
Other Study ID Numbers  ICMJE 450072
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University of California, Davis
Original Responsible Party Kathleen Angkustsiri, MD, University of California, Davis, Assistant Professor
Current Study Sponsor  ICMJE University of California, Davis
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kathleen Angkustsiri, MD UC Davis MIND Institute
PRS Account University of California, Davis
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP