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

May 31, 2019 updated by: University of California, Davis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • Uc Davis Mind Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Dietary supplement: Synbiotic
Other Names:
  • Bifidobacterium infantis SC268
  • bovine colostrum, bovine oligosaccharides
Dietary supplement: Prebiotic
Other Names:
  • bovine colostrum, bovine oligosaccharides
Active Comparator: 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.
Dietary supplement: Synbiotic
Other Names:
  • Bifidobacterium infantis SC268
  • bovine colostrum, bovine oligosaccharides
Dietary supplement: Prebiotic
Other Names:
  • bovine colostrum, bovine oligosaccharides

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stool Microbiota Composition Change During Prebiotic Only Treatment
Time Frame: Five weeks
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
Time Frame: Five weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Immune Profile Change During Prebiotic Only Treatment
Time Frame: Five weeks
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.
Five weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Investigators

  • Principal Investigator: Kathleen Angkustsiri, MD, Uc Davis Mind Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2014

Primary Completion (Actual)

November 16, 2015

Study Completion (Actual)

November 16, 2015

Study Registration Dates

First Submitted

March 7, 2014

First Submitted That Met QC Criteria

March 11, 2014

First Posted (Estimate)

March 13, 2014

Study Record Updates

Last Update Posted (Actual)

August 1, 2019

Last Update Submitted That Met QC Criteria

May 31, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 450072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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