A Pilot Study Examining Microbiota Composition in Children With Autism and Gastrointestinal Symptoms After Use of Bifidobacterium Infantis and Milk Oligosaccharides
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Autism
- Sponsor
- University of California, Davis
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Stool Microbiota Composition Change During Prebiotic Only Treatment
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Serum Immune Profile Change During Prebiotic Only Treatment(Five weeks)