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

University of California (UC) Davis

Status: Completed

Conditions: Autism

Treatments: Dietary Supplement: Prebiotic; Dietary Supplement: Synbiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT02086110

450072

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 2 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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11 participants in 2 patient groups

Prebiotic only first, then synbiotic

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Synbiotic

Dietary Supplement: Prebiotic

Synbiotic first, then prebiotic only

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Synbiotic

Dietary Supplement: Prebiotic