Effect of Milk Oligosaccharides and Bifidobacteria on the Intestinal Microflora of Children With Autism
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Psychiatric, Autism |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 2 - 11 |
| Updated: | 5/19/2018 |
| Start Date: | June 6, 2014 |
| End Date: | November 16, 2015 |
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.
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.
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.
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
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