Baylor College of Medicine Study to Investigate Why Some Children's Autism Symptoms Change When Taking Antibiotics.
Study is wholly funded by N of One: Autism Research Foundation and is open to children nationwide
For years many parents have reported that their children's autism symptoms change while taking antibiotics. Most typically, these reports are of improvements but sometimes symptoms worsen on antibiotics.
Since autism has been associated with changes in the microbiome, researchers have speculated that changes in the gut bacteria caused by antibiotics may be behind the changes. In a clinical trial conducted in 2000 at Chicago Rush Children's Hospital, significant improvements were seen in 8 of 10 boys with severe autism while taking the antibiotic vancomycin where the researchers speculated that changes induced in the gut bacteria were behind the improvements. This study seeks to further that research.
This first-of-its kind study will follow children over a two-year period and capture information and specimens anytime antibiotics are prescribed by their regular physicians. Researchers will then compare changes in the gut microbiome (bacteria, yeasts and fungi found in the gut) and metabolome (small biological molecules produced by the microbes) during antibiotic use of those who experience a change in symptoms during to those who do not. The study seeks to understand when and why these changes occur and how this information can be harnessed for future interventions.
Eligibility and Participation
Eligible participants are children 2-17 years of age with a diagnosis of autism or autism spectrum disorder (ASD) as well as typically developing children. The study will collect data on behavior, abdominal pain, the microbiome and the metabolome in the gastrointestinal tract. Participation is easy, there is no pain involved, and participants will be compensated.
Antibiotics are not prescribed by the trial. That is done when and if needed by the child's regular healthcare provider.
In order to participate, parents must enroll their children before they actually need antibiotics so they receive their materials in advance. Once enrolled, parents will be asked to provide two stool specimens as well as complete several surveys and diaries should they be prescribed antibiotics by their healthcare provider The stool specimen will be used to determine differences in microbes and metabolites before and after taking antibiotics. Behavior will also be compared to the results of the microbes and metabolites analyses.
It is important that interested parents enroll their children as soon as possible before they need antibiotics for any illnesses as their may not be enough time to enroll and send materials out once they actually need antibiotics
This study is being conducted by Baylor College of Medicine in conjunction with Texas Children's Hospital, and is solely funded by N of One Autism Research Foundation.
The trial is open to children nationwide. Parents are encouraged to enroll their typically developing children as this will provide additional information to researchers.
Parents who are interested in participating in the trial can visit the trial website:
https://www.bcm.edu/research/clinical-trials/h-39137 or contact Dr Luna at firstname.lastname@example.org
About N of One: Autism Research Foundation:
N of One: Autism Research Foundation's mission is to facilitate and sponsor breakthrough autism medical research. N of One emphasizes research that treats the observations of parents and doctors as potential clues to how autism works and seeks to turn those into breakthroughs. Headquartered in Dallas, TX in 2014, it has been a leader in focusing on the role of the microbiome in autism.