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

NCT02086110 | Completed Results

• 1 other identifier: 450072
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism

Keywords

probiotic; prebiotic; autism; oligosaccharides; Bifidobacterium infantis

Outcome Measures

Primary Outcomes (2)

• Stool Microbiota Composition Change During Prebiotic Only Treatment

  The stool microbiome composition will be analyzed through next generation sequencing and quantitative polymerase chain reaction. Overall bacterial composition change is reported here, as change in enterotype from before prebiotic only treatment to after prebiotic treatment, for all subjects. Enterotypes were organized into four categories for analysis: a community high in Prevotella ("Prevotella"), a community high in Bifidobacterium ("Bifidobacterium"), a community high in Bacteroides ("Bacteroides"), and a mixed community ("Mixed") that did not fall into one of the other three enterotypes but instead consisted of a varied combination of bacteria, including among others Akkermansia, Collinsela, Prevotella, and/or Bacteroides.

  Five weeks

• Stool Microbiota Composition Change During Synbiotic Treatment

  The stool microbiome composition will be analyzed through next generation sequencing and quantitative polymerase chain reaction. Overall bacterial composition change is reported here, as change in enterotype from before synbiotic treatment to after synbiotic treatment, for all subjects. Enterotypes were organized into four categories for analysis: a community high in Prevotella ("Prevotella"), a community high in Bifidobacterium ("Bifidobacterium"), a community high in Bacteroides ("Bacteroides"), and a mixed community ("Mixed") that did not fall into one of the other three enterotypes but instead consisted of a varied combination of bacteria, including among others Akkermansia, Collinsela, Prevotella, and/or Bacteroides.

  Five weeks

Secondary Outcomes (1)

• Serum Immune Profile Change During Prebiotic Only Treatment

  Five weeks

Study Arms (2)

Prebiotic only first, then synbiotic

ACTIVE COMPARATOR

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.

Dietary Supplement: Synbiotic; Dietary Supplement: Prebiotic

Synbiotic first, then prebiotic only

ACTIVE COMPARATOR

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.

Dietary Supplement: Synbiotic; Dietary Supplement: Prebiotic

Interventions

Synbiotic DIETARY_SUPPLEMENT

Also known as: Bifidobacterium infantis SC268, bovine colostrum, bovine oligosaccharides

Prebiotic only first, then synbiotic; Synbiotic first, then prebiotic only

Prebiotic DIETARY_SUPPLEMENT

Also known as: bovine colostrum, bovine oligosaccharides

Prebiotic only first, then synbiotic; Synbiotic first, then prebiotic only

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Autism
• Diarrhea and/or constipation

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis MIND Institute

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Autistic Disorder

Interventions

Synbiotics; Prebiotics

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Probiotics; Food and Beverages; Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides

Limitations and Caveats

Lack of a clear control group receiving a placebo, resulting in possible placebo effect (partially addressed by study's cross-over design). Study duration was short. Lack of a probiotic only arm to parse out specific treatment effects.

Results Point of Contact

• Title: Dr. Kathleen Angkustsiri
• Organization: University of California, Davis Health System

kangkustsiri@ucdavis.edu

916-703-0278

Study Officials

• Kathleen Angkustsiri, MD

  UC Davis MIND Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2014
• First Posted: March 13, 2014
• Study Start: June 6, 2014
• Primary Completion: November 16, 2015
• Study Completion: November 16, 2015
• Last Updated: August 1, 2019
• Results First Posted: August 1, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)