title: A Randomized, Placebo-controlled Trial of Digestive Enzymes in Children with Autism Spectrum Disorders.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Pediatrics, Faculty of Medicine, Assiut University, Assiut, Egypt.
authors.forename: Khaled
authors.initials: K
authors.lastname: Saad
authors.affiliation: Department of Pediatrics, Faculty of Medicine, Assiut University, Assiut, Egypt.
authors.forename: Azza A
authors.initials: AA
authors.lastname: Eltayeb
authors.affiliation: Department of Pediatrics, Faculty of Medicine, Assiut University, Assiut, Egypt.
authors.forename: Ismail L
authors.initials: IL
authors.lastname: Mohamad
authors.affiliation: Department of Psychiatry, College of Medicine, Almajmaah University, Kingdom of Saudi Arabia.
authors.forename: Abdulrahman A
authors.initials: AA
authors.lastname: Al-Atram
authors.affiliation: Department of Neuropsychiatry, Assiut University, Assiut, Egypt.
authors.forename: Yasser
authors.initials: Y
authors.lastname: Elserogy
authors.affiliation: Council for Nutritional and Environmental Medicine, Mo i Rana, Norway.
authors.forename: Geir
authors.initials: G
authors.lastname: Bjørklund
authors.affiliation: Department of Community Health Nursing, Faculty of Nursing and Health Allied, Jazan University, Kingdom of Saudi Arabia.|Faculty of Nursing, Assiut University, Assiut, Egypt.
authors.forename: Amira A
authors.initials: AA
authors.lastname: El-Houfey
authors.affiliation: Nicholson Science, Tampa, FL, USA.
authors.forename: Bubba
authors.initials: B
authors.lastname: Nicholson
keywords: Autism spectrum disorders; Child; Clinical trial; Digestive enzymes