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

Primary Purpose

Autism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Synbiotic
Prebiotic
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Autism focused on measuring probiotic, prebiotic, autism, oligosaccharides, Bifidobacterium infantis

Eligibility Criteria

2 Years - 11 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • UC Davis MIND Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Prebiotic only first, then synbiotic

Synbiotic first, then prebiotic only

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Serum Immune Profile Change During Prebiotic Only Treatment
Luminex technology will be used to determine a serum immune profile of each participants in response to the study supplement. This profile included assessment of change in percentage of stimulated CD4+ T cells producing intracellular IL-13 before and after Synbiotic treatment ("Post-Synbiotic % IL-13"), and assessment of change in percentage of stimulated CD8+ T cells producing TNF-alpha before and after Prebiotic Only treatment ("Post-Prebiotic % TNF-alpha"). Results are reported here for all subjects regardless of treatment order assignment. Decrease in inflammatory cytokines IL-13 and TNF-alpha is interpreted as a positive outcome.

Full Information

First Posted
March 7, 2014
Last Updated
May 31, 2019
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT02086110
Brief Title
Effect of Milk Oligosaccharides and Bifidobacteria on the Intestinal Microflora of Children With Autism
Official Title
A Pilot Study Examining Microbiota Composition in Children With Autism and Gastrointestinal Symptoms After Use of Bifidobacterium Infantis and Milk Oligosaccharides
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 6, 2014 (Actual)
Primary Completion Date
November 16, 2015 (Actual)
Study Completion Date
November 16, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism
Keywords
probiotic, prebiotic, autism, oligosaccharides, Bifidobacterium infantis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prebiotic only first, then synbiotic
Arm Type
Active Comparator
Arm 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.
Arm Title
Synbiotic first, then prebiotic only
Arm Type
Active Comparator
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Synbiotic
Other Intervention Name(s)
Bifidobacterium infantis SC268, bovine colostrum, bovine oligosaccharides
Intervention Type
Dietary Supplement
Intervention Name(s)
Prebiotic
Other Intervention Name(s)
bovine colostrum, bovine oligosaccharides
Primary Outcome Measure Information:
Title
Stool Microbiota Composition Change During Prebiotic Only Treatment
Description
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.
Time Frame
Five weeks
Title
Stool Microbiota Composition Change During Synbiotic Treatment
Description
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.
Time Frame
Five weeks
Secondary Outcome Measure Information:
Title
Serum Immune Profile Change During Prebiotic Only Treatment
Description
Luminex technology will be used to determine a serum immune profile of each participants in response to the study supplement. This profile included assessment of change in percentage of stimulated CD4+ T cells producing intracellular IL-13 before and after Synbiotic treatment ("Post-Synbiotic % IL-13"), and assessment of change in percentage of stimulated CD8+ T cells producing TNF-alpha before and after Prebiotic Only treatment ("Post-Prebiotic % TNF-alpha"). Results are reported here for all subjects regardless of treatment order assignment. Decrease in inflammatory cytokines IL-13 and TNF-alpha is interpreted as a positive outcome.
Time Frame
Five weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Angkustsiri, MD
Organizational Affiliation
UC Davis MIND Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis MIND Institute
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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