The study of protective role of Pre-/ Post-biotics in Rett syndrome
Azienda Ospedaliera Universitaria Senese is recruiting patients for the clinical trial of Protective Role of Pre-/ Post-biotics on Gut Inflammation, Dysbiosis, and Life Quality in Rett Syndrome (Xbiotics_RTT) (Biotics_RTT).
The study will examine the potential efficacy and safety of two pre- and post-biotics on markers for gut inflammation and intestinal microbiota ecology in patients with Rett syndrome. Moreover, this trial will search for possible effects on epileptogenesis and quality of life.
The gastrointestinal tract is the major site of exposure to environmental molecules where 1) dietary components are chemically transformed by the microbiota, and 2) gut-derived metabolites are disseminated to all organs, including the brain. The human gut microbiota directly affects human health, and its alteration can lead to gastrointestinal abnormalities and inflammation. Indeed, accumulating clinical and experimental evidences indicate that the gut microbiota impacts behavior, modulates neurotransmitter production in the gut and brain, influences brain development and myelination patterns.
Double (Investigator, Outcomes Assessor).
The researchers plan that April 1, 2022 will be the study start date. The indicative completion of the clinical trial will be expected in February 21, 2023.
Among primary outcome measures are the Improvement of gut inflammation and Decrease in fecal calprotectin levels.
The study will take place at the Policlinico "S. Maria alle Scotte" Azienda Ospedaliera Universitaria Senese, Siena, Italy.
The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT05420805 or https://clinicaltrials.gov/ct2/show/NCT05420805.
