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

Autism Clinical Trial

Official title:

A Pilot Study Examining Microbiota Composition in Children With Autism and Gastrointestinal Symptoms After Use of Bifidobacterium Infantis and Milk Oligosaccharides

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02086110
• Other study ID #: 450072
• Status: Completed
• Phase: N/A
• Start date: June 6, 2014
• Est. completion date: November 16, 2015

Study information

• Verified date: May 2019
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: November 16, 2015
• Est. primary completion date: November 16, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

Dietary Supplement:
• Synbiotic

• Prebiotic

Locations

Country	Name	City	State
United States	UC Davis MIND Institute	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Five weeks