N/A
Completed N=11
Effect of Milk Oligosaccharides and Bifidobacteria on the Intestinal Microflora of Children With Autism
Source: ClinicalTrials.gov NCT02086110 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: Stool Microbiota Composition Change During Prebiotic Only Treatment — 2; 3; 1; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stool Microbiota Composition Change During Prebiotic Only Treatment |
2; 3; 1; 0; 1; 0 | — |
| PRIMARY Stool Microbiota Composition Change During Synbiotic Treatment |
4; 2; 0; 1; 0; 1 | — |
| SECONDARY Serum Immune Profile Change During Prebiotic Only Treatment |
-0.8; -7.9 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02086110). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.