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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

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.

Condition or disease Intervention/treatment Phase
Autism Dietary Supplement: Synbiotic Dietary Supplement: Prebiotic Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, 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
Actual Study Start Date : June 6, 2014
Actual Primary Completion Date : November 16, 2015
Actual Study Completion Date : November 16, 2015

Arm Intervention/treatment
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.
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, 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.
Dietary Supplement: Synbiotic
Other Names:
  • Bifidobacterium infantis SC268
  • bovine colostrum, bovine oligosaccharides

Dietary Supplement: Prebiotic
Other Name: bovine colostrum, bovine oligosaccharides




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   2 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02086110


Locations
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United States, California
UC Davis MIND Institute
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Kathleen Angkustsiri, MD UC Davis MIND Institute
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02086110    
Other Study ID Numbers: 450072
First Posted: March 13, 2014    Key Record Dates
Results First Posted: August 1, 2019
Last Update Posted: August 1, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of California, Davis:
probiotic
prebiotic
autism
oligosaccharides
Bifidobacterium infantis
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders