Status:
COMPLETED
Protective Role of Pre-/ Post-biotics on Gut Inflammation, Dysbiosis, and Life Quality in Rett Syndrome (Biotics_RTT)
Lead Sponsor:
Azienda Ospedaliera Universitaria Senese
Collaborating Sponsors:
Kolfarma s.r.l. - Italy
European Institute of Oncology
Conditions:
Rett Syndrome
Dysbiosis
Eligibility:
FEMALE
3+ years
Phase:
NA
Brief Summary
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 t...
Detailed Description
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 dissemi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2023
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT05420805
Start Date
April 1 2022
End Date
February 28 2023
Last Update
April 18 2023
Active Locations (1)
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1
Policlinico "S. Maria alle Scotte" Azienda Ospedaliera Universitaria Senese
Siena, Italy, 53100