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A Randomized, Placebo-controlled Trial of Digestive Enzymes in Children with Autism Spectrum Disorders
Khaled Saad1, Azza A Eltayeb1, Ismail L Mohamad1
1Department of Pediatrics, Faculty of Medicine, Assiut University, Assiut, Egypt.
Insights
Digestive enzyme therapy shows mild benefits for children with autism spectrum disorder (ASD), improving emotional response, behavior, and gut symptoms. This safe and accessible treatment may be a future option for managing ASD.
Area of Science:
- Neurogastroenterology
- Pediatric Neurology
- Biochemistry
Background:
- Growing evidence supports a gut-brain connection in autism spectrum disorders (ASD).
- Digestive enzymes may offer therapeutic benefits for children with ASD.
Purpose of the Study:
- To investigate the efficacy of digestive enzyme supplementation in children with ASD.
- To assess the impact of digestive enzymes on behavioral and gastrointestinal symptoms in ASD patients.
Main Methods:
- A double-blind, randomized clinical trial involving 101 children (ages 3-9) diagnosed with ASD.
- Participants received either digestive enzymes or a placebo for 3 months.
- Assessments included structured interviews and the Childhood Autism Rating Scale (CARS).
Main Results:
- The group receiving digestive enzymes showed significant improvements in emotional response, general autistic score, and behavior.
- Gastrointestinal symptoms were also significantly improved in the enzyme-treated group.
- The study demonstrated the usefulness of digestive enzymes in the studied ASD population.
Conclusions:
- Digestive enzymes are inexpensive, safe, and readily available.
- Mildly beneficial effects were observed in ASD patients, suggesting their potential for symptom management.
- Digestive enzyme therapy could be a future option in treatment protocols for ASD.
Objective:
There is growing evidence for a gut-brain connection associated with autism spectrum disorders (ASDs). This suggests a potential benefit from introduced digestive enzymes for children with ASD.
Methods:
We performed a double-blind, randomized clinical trial on 101 children with ASD (82 boys and 19 girls) aged from 3 to 9 years. ASD patients were diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders 4th edition, text revision (DSM-IV-TR) diagnostic criteria. Structured interviews of at least one hour each both with the parents and the child were performed. Later on, another two hours-session was conducted applying the Childhood Autism Rating Scale (CARS). ASD patients were randomized to receive digestive enzymes or placebo.
Results:
The ASD group receiving digestive enzyme therapy for 3 months had significant improvement in emotional response, general impression autistic score, general behavior and gastrointestinal symptoms. Our study demonstrated the usefulness of digestive enzyme in our population of ASD patients.
Conclusion:
Digestive enzymes are inexpensive, readily available, have an excellent safety profile, and have mildly beneficial effects in ASD patients. Depending on the parameter measured in our study, we propose digestive enzymes for managing symptoms of ASD. Digestive enzyme therapy may be a possible option in treatment protocols for ASD in the future.

