Actively Recruiting

Phase Not Applicable
Age: 3Years - 50Years
All Genders
NCT06448663

Targeting the Gut to Improve Seizure Control in CDKL5 Deficiency Disorder (CDD)

Led by University of Milan · Updated on 2024-06-07

20

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

Sponsors

U

University of Milan

Lead Sponsor

F

Fondazione Telethon

Collaborating Sponsor

AI-Summary

What this Trial Is About

Standard anti-seizure medications have limited efficacy in seizure control in cyclin-dependent kinase-like 5 deficiency disorder (CDD). The study will investigate whether targeting the gut-microbiota-brain axis in CDD patients can alleviate seizures and ameliorate other comorbidities.

CONDITIONS

Official Title

Targeting the Gut to Improve Seizure Control in CDKL5 Deficiency Disorder (CDD)

Who Can Participate

Age: 3Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of CDD with confirmed CDKL5 pathogenic variant
  • Drug-resistant seizures
  • Participation of a caregiver ensured
  • Willingness to sign informed consent
Not Eligible

You will not qualify if you...

  • Organic gastrointestinal disorders such as food allergies or celiac disease
  • Special diets
  • Percutaneous endoscopic gastrostomy tube
  • Use of antibiotics or probiotics in the previous month

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Milan

Milan, Italy

Actively Recruiting

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Research Team

A

Aglaia Vignoli, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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Targeting the Gut to Improve Seizure Control in CDKL5 Deficiency Disorder (CDD) | DecenTrialz