ArticleClinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology2015
A Randomized, Placebo-controlled Trial of Digestive Enzymes in Children with Autism Spectrum Disorders.
Article in Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 51 citations in OpenAlex.
- Complementary and Alternative Medicine for Autism - A Systematic Review.Journal of autism and developmental disorders · 2025Pooled it
- Effectiveness of interventions for children and adolescents with autism spectrum disorder in high-income vs. lower middle-income countries: An overview of systematic reviews and research papers from LMIC.Frontiers in psychiatry · 2022Pooled it
- Comprehensive Nutritional and Dietary Intervention for Autism Spectrum Disorder-A Randomized, Controlled 12-Month Trial.Nutrients · 2018Trial
- Gastrointestinal health and nutritional strategies in autism spectrum disorder.Journal of gastroenterology · 2025Review
- Harnessing the Gut Microbiome: To What Extent Can Pre-/Probiotics Alleviate Immune Activation in Autism Spectrum Disorder?Nutrients · 2024Review
- Between Dysbiosis, Maternal Immune Activation and Autism: Is There a Common Pathway?Nutrients · 2024Review
- Gluten-Free, Casein-Free Diet for Children with Autism Spectrum Disorder: A Case-Controlled Study.Journal of pharmacy & bioallied sciences · 2024Article
- Review
- Fecal Microbiota Transplantation in Autism Spectrum Disorder.Neuropsychiatric disease and treatment · 2022Review
- Ratings of the Effectiveness of Nutraceuticals for Autism Spectrum Disorders: Results of a National Survey.Journal of personalized medicine · 2021Article
- Effects of the Prenatal Administration of Tetanus Toxoid on the Sociability and Explorative Behaviors of Rat Offspring: A Preliminary Study.Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology · 2021Article
- Relationship between Vitamin Deficiencies and Co-Occurring Symptoms in Autism Spectrum Disorder.Medicina (Kaunas, Lithuania) · 2020Review
- Study on Aberrant Eating Behaviors, Food Intolerance, and Stereotyped Behaviors in Autism Spectrum Disorder.Frontiers in psychiatry · 2020Article
- Levels of Salivary Sialic Acid in Children with Autism Spectrum Disorder; Could It Be Related to Stereotypes and Hyperactivity?Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology · 2019Article
- The Role of Vitamins in Autism Spectrum Disorder: What Do We Know?Journal of molecular neuroscience : MN · 2019Review
- Diagnostic and Severity-Tracking Biomarkers for Autism Spectrum Disorder.Journal of molecular neuroscience : MN · 2018Review
- "Immune Gate" of Psychopathology-The Role of Gut Derived Immune Activation in Major Psychiatric Disorders.Frontiers in psychiatry · 2018Review
- Dietary Considerations in Autism Spectrum Disorders: The Potential Role of Protein Digestion and Microbial Putrefaction in the Gut-Brain Axis.Frontiers in nutrition · 2018Review
- Dietary Supplement for Core Symptoms of Autism Spectrum Disorder: Where Are We Now and Where Should We Go?Frontiers in psychiatry · 2017Review
- Evaluation of whole blood zinc and copper levels in children with autism spectrum disorder.Metabolic brain disease · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThere 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.
methodsWe 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.
resultsThe 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.
conclusionDigestive 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.