Digestion problems could play a role in a child's susceptibility to autism or the severity of the condition. A new experimental drug is being fast-tracked by the Food and Drug Administration and could prove helpful in the fight against autism.
Doctors and specialists have long suspected a link between a child's ability to digest certain foods and autism. A new drug trial is being conducted in 12 study sites across the U.S., including Mount Sinai Medical Center in New York and The University of Texas Health Science Center at Houston. The study involves a randomized double blind placebo controlled trial involving a drug that affects ancreatic enzymes.
Participants in the study will mix the drug, called Luminez-AT(TM), into their food. It purportedly helps the body digest protein. It is believed that many children with autism cannot digest protein from foods. This would cause them to lack the necessary amino acids that are critical in producing neurotransmitters in the brain. Various symptoms of autism and behavioral issues may result.
The new phase of the study will look at children with autism between the ages of 3 to 8. The participant will take the actual medication or a placebo for 12 weeks. The medication is a tasteless drug sprinkled on food. The participants are required to come in for six clinical visits during the 12-week period.
In earlier studies of the drug that involved almost 500 children, few had side effects. Results of the new study will take about a year, but many people involved in the study already feel hopeful about the results for autism spectrum disorders (ASD).
According to Curemark, an organization spearheading the research, "A variant of the MET gene involved in brain development and gut repair has been implicated in autism." This could be the reason behind the low level of the pancreatic enzyme to digest protein in those with ASD.
Penn State University Hershey Children's Hospital, one of the sites where the phase III study is being conducted, offers this summary of the drug Luminez-AT:
LUMINEZ-AT(TM) is a lipid-encapsulated pancreatic enzyme concentrate (PEC) designed to release chymotrypsin and other proteases in the small intestine without extreme degradation. Research conducted by Curemark has indicated that digestive enzyme therapy with LUMINENZ-AT(TM) may lead to increased neurological function and a concomitant reduction in autistic and gastrointestinal symptoms. This study will further quantify the changes in the target population as measured by standardized behavioral and quality of life tests, physiological measures, as well as characterize the efficacy and safety of the product. The data from this study will help determine safety and efficacy of LUMINENZ-AT(TM) in pediatric patients with autism.
The digestion connection with autism could help the thousands of children who have ASD. The Centers for Disease Control and Prevention says that currently one in 110 children in the U.S. are diagnosed with autism spectrum disorders. Many children are not diagnosed with autism until they reach school age, and because autism diagnosis is largely based on a child's behavior, diagnosis is not an exact science.
Children with ASD have some similar symptoms:
* Problems developing nonverbal communication skills, such as eye-to-eye gazing, facial expressions, and body posture.
* Failure to establish friendships with children of the same age.
* Lack of interest sharing enjoyment.
* Lack of empathy.
* Delay or inability to learn to talk.
* A need for sameness or routine.
* Repetitive use of language.
If diagnosed early, symptoms of ASD may be lessened through therapy. Others are hopeful that the new drug trial will provide another avenue for alleviating symptoms.