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

NCT06448663 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-06-07

No results posted yet for this study

Summary

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

  • CDKL5

Interventions

DIETARY_SUPPLEMENT

alpha-lactalbumin, fructooligosaccharides, inulin

The first round supplementation will be administered for 3-month period (i.e. 12 weeks). One dose/day (2g sachet) is intended to be administered orally once a day after dissolving in water. At the scheduled visits/phone contacts \[i.e., baseline, 12 weeks, and 16 weeks (post washout)\], seizure frequency and entity of the critical episodes will be recorded. Gut microbiome characterization, clinical scales and dietary intake will be assessed.

DIETARY_SUPPLEMENT

alpha-lactalbumin, sodium butyrate, fructooligosaccharides, inulin

The second round supplementation will be administered for 3-month period (i.e. 12 weeks). For participants weighing \<30 kg, a 4 g dose (i.e., one 4 g sachet) is intended to be administered orally once a day after dissolving in water. For participants weighing ≥30 kg, a 4 g dose (i.e., 4 g sachets) is intended to be administered orally twice a day (12h interval) after dissolving in water. At the scheduled visits/phone contacts \[i.e., 28 weeks and 32 weeks (post washout)\], seizure frequency and entity of the critical episodes will be recorded. Gut microbiome characterization, clinical scales and dietary intake will be assessed.

Sponsors & Collaborators

  • Fondazione Telethon

    collaborator OTHER

  • Kolfarma s.r.l. - Italy

    collaborator UNKNOWN

  • University of Milan

    lead OTHER

Principal Investigators

  • Aglaia Vignoli, MD · University of Milan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
3 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2025-01-31
Completion
2025-04-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06448663 on ClinicalTrials.gov