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Completed

NCT Number: NCT02086110

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

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.

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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

2 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis MIND Institute

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Synbiotic

Dietary Supplement

Other names: Bifidobacterium infantis SC268, bovine colostrum, bovine oligosaccharides

Prebiotic

Dietary Supplement

Other names: bovine colostrum, bovine oligosaccharides

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

A Pilot Study Examining Microbiota Composition in Children With Autism and Gastrointestinal Symptoms After Use of Bifidobacterium Infantis and Milk Oligosaccharides

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 13, 2014
Registry last updated
Aug 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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