Effect of Milk Oligosaccharides and Bifidobacteria on the Intestinal Microflora of Children With Autism
NCT ID: NCT02086110
Last Updated: 2019-08-01
Study Results
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View full resultsBasic Information
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COMPLETED
NA
11 participants
INTERVENTIONAL
2014-06-06
2015-11-16
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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Prebiotic only first, then synbiotic
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.
Synbiotic
Prebiotic
Synbiotic first, then prebiotic only
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.
Synbiotic
Prebiotic
Interventions
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Synbiotic
Prebiotic
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diarrhea and/or constipation
Exclusion Criteria
* 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
2 Years
11 Years
ALL
No
Sponsors
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University of California, Davis
OTHER
Responsible Party
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Principal Investigators
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Kathleen Angkustsiri, MD
Role: PRINCIPAL_INVESTIGATOR
UC Davis MIND Institute
Locations
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UC Davis MIND Institute
Sacramento, California, United States
Countries
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Other Identifiers
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450072
Identifier Type: -
Identifier Source: org_study_id
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