Effect of Ayurveda gut therapy protocol in managing dysbiosis of children with autism: study protocol for a randomized controlled trial

Abstract

Background and objectives: Emerging evidences indicate an invariable relationship between gut dysbiosis and neurobehavioral symptoms of autism spectrum disorder. In India, Ayurveda is widely accepted among the complementary and alternative medicine. This study aimed to assess the efficacy of an Ayurveda gut therapy protocol in autism spectrum disorder. Subjects and methods: In this randomized controlled trial, 60 children with autism spectrum disorder admitted to Vaidyaratnam P S Varier Ayurveda College, India will be randomly assigned to intervention and control groups. The intervention group will undergo Ayurveda gut therapy protocol for 30 days and interdisciplinary interventions for 2 months, whereas the control group will undergo only interdisciplinary interventions for 2 months. A final assessment will be done on the 60 th day. Patient recruitment began in July 2018. The primary and secondary outcome measure will be completed in January 2021 and the study will be completed in September 2022. The study was approved by the Institutional Ethical Committee of Vaidyaratnam P S Varier Ayurveda College, India (Proceedings No: IEC/CI/24/17) on May 4, 2017. Protocol version: 1.0. Outcome measures: The expected primary outcome is to assess the quality and quantity of the gut microbes through 16s rRNA sequencing. The secondary outcome expected is the changes in the neurobehavioral symptoms assessed through the Childhood Autism Rating Scale and also changes in the gastrointestinal symptoms assessed through Ayurveda Gut Health Assessment Questionnaire. Discussion: The current protocol discusses the relationship between Autism and gut dysbiosis and its management through Ayurveda, and provides evidence for the rationality of using Ayurveda gut therapy as an alternative therapy for autism spectrum disorder in clinical practice. Trial registration: The study was registered with Clinical Trial Registry of India (registration No. CTRI/2018/05/014017, registered on May 21, 2018).