Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT05420805
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of classic/typical Rett syndrome (and proven loss-of-function mutation of the MeCP2 gene) with gastrointestinal dysfunction and/or positive history of epilepsy
* Female gender (age \> / = 3 years old)
* Ability to obtain written informed consent from their parent(s)/legal guardian(s)
* Stable medications for at least 4 weeks prior to the baseline visit.
Exclusion Criteria:
* Diagnosis not fitting into the Rett syndrome consensus guidelines
* Nonpathogenic MECP2 mutation or mutations in non-MECP2 genes (i.e., cyclin-dependent kinase 5, CDKL5; forkhead box protein G1, FOXG1)
* Male gender
* Percutaneous endoscopic gastrostomy (PEG) tube
* Proven hypersensitivity to one or more components of the dietary supplements (X-biotics)
* Unstable concomitant medications less than 4 weeks prior to enrollment visit.
* Concomitant antibiotic therapy at the enrollment. In the case of antibiotic therapy, a 4-weeks washout period will be undertaken.
* Rejection of the informed consent form by the parents/caregivers and/or lack of compliance to the Study procedures.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
3 Years
Study:
NCT05420805
Study Brief:
Protocol Section:
NCT05420805