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

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

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.

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.

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