An interventional study of Synbiotic and Prebiotic in Autism, sponsored by University of California, Davis. Completed at 1 site in United States. Open to participants aged 2 Years to 11 Years. Per ClinicalTrials.gov, last updated 2019-08-01.
Sponsored by University of California, Davis · Not applicable, Interventional, and Basic science
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.
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.
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's enrollment of 11 is below the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Also known as: Bifidobacterium infantis SC268, bovine colostrum, bovine oligosaccharides
Also known as: bovine colostrum, bovine oligosaccharides
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.
Time frame: 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.
Time frame: Five weeks
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.
Time frame: Five weeks
| Milestone | Prebiotic Only First, Then Synbiotic | Synbiotic First, Then Prebiotic Only |
|---|---|---|
| Started | 5 | 6 |
| Completed | 4 | 5 |
| Not completed | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
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.
| Participants | Prebiotic Only First, Then Synbiotic | Synbiotic First, Then Prebiotic Only |
|---|---|---|
| No change in enterotype | 2 | 3 |
| Bifidobacterium to Prevotella | 1 | 0 |
| Bacteroides to Bifidobacterium | 1 | 0 |
| Prevotella to Bifidobacterium | 0 | 1 |
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.
| Participants | Prebiotic Only First, Then Synbiotic | Synbiotic First, Then Prebiotic Only |
|---|---|---|
| No change in enterotype | 4 | 2 |
| Prevotella to Mixed | 0 | 1 |
| Prevotella to Bifidobacterium | 0 | 1 |
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.
| percentage of cytokine production | All Subjects |
|---|---|
| Post-Synbiotic % IL-13 | -0.8 (-2.073 to -0.524) |
| Post-Prebiotic % TNF-alpha | -7.9 (-14.375 to -1.425) |
Collected over Adverse event data was collected from time of consent through end-of-treatment (12 weeks total).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prebiotic Only Arm | 0/10 (0%) | 0/10 (0%) | 10/10 (100%) |
| Synbiotic Arm | 0/10 (0%) | 0/10 (0%) | 10/10 (100%) |
| Event | Prebiotic Only Arm | Synbiotic Arm |
|---|---|---|
| Pain associated with bowel movementsGastrointestinal disorders | 3/10 | 3/10 |
| Increased gassinessGastrointestinal disorders | 2/10 | 2/10 |
| DiarrheaGastrointestinal disorders | 2/10 | 2/10 |
| ConstipationGastrointestinal disorders | 2/10 | 2/10 |
| BloatingGastrointestinal disorders | 1/10 | 2/10 |
| Weight gainMetabolism and nutrition disorders | 0/10 | 2/10 |
| StomachacheGastrointestinal disorders | 1/10 | 0/10 |
| Sleep disturbancesPsychiatric disorders | 1/10 | 0/10 |
| LethargyPsychiatric disorders | 1/10 | 0/10 |
| HivesSkin and subcutaneous tissue disorders | 0/10 | 1/10 |
| Age, Categorical(Participants) | Prebiotic Only First, Then Synbiotic | Synbiotic First, Then Prebiotic Only | Total |
|---|---|---|---|
| <=18 years | 5 | 6 | 11 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Prebiotic Only First, Then Synbiotic | Synbiotic First, Then Prebiotic Only | Total |
|---|---|---|---|
| Female | 1 | 1 | 2 |
| Male | 4 | 5 | 9 |
| Race/Ethnicity, Customized(Participants) | Prebiotic Only First, Then Synbiotic | Synbiotic First, Then Prebiotic Only | Total |
|---|---|---|---|
| White, non-Hispanic | 3 | 5 | 8 |
| African-American, non-Hispanic | 1 | 0 | 1 |
| White, Hispanic/Latino | 1 | 1 | 2 |
| African-American, Hispanic/Latino | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Prebiotic Only First, Then Synbiotic | Synbiotic First, Then Prebiotic Only | Total |
|---|---|---|---|
| United States | 5 | 6 | 11 |
Plan to share: No
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University of California, Davis