Using Glialia for Treating Persistent Perceptual Postural Dizziness (GLI-PPPD)

I.R.C.C.S. Fondazione Santa Lucia

Status and phase: Enrolling; Phase 4

Conditions: Persistent Postural Perceptual Dizziness

Treatments: Other: Control; Other: Glialia; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06741358

N.153/SL/24

Details and patient eligibility

About

This pilot study will involve 30 participants recruited from the Santa Lucia Foundation IRCCS, including 20 patients diagnosed with Persistent Perceptual Postural Dizziness (PPPD), and might or might not have previously contracted Sars Cov2 infection. They who will be randomly assigned to receive either the Glialia supplement or placebo. Additionally, 10 control participants who have recovered from COVID-19 will receive Glialia to help assess the influence of previous COVID-19 infection on neuroinflammation levels. The study aims to compare baseline neuroinflammation levels between PPPD patients and controls, measure changes in neuroinflammation in all groups after treatment and to determine if the reduction in neuroinflammation is more significant in the Glialia group compared to the placebo group. The trial will be conducted in a triple-blind manner, ensuring that neither participants nor researchers know the treatment assignments. Each participant will receive sachets to be taken daily for 60 days, with the study providing both the Glialia supplement and placebo at no cost.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria for all groups:

-Age between 18 and 65 years.

Inclusion criteria for the PPPD-glialia group:

• Diagnosis of PPPD;
• Recovery from COVID-19 infection or absence of previous infection.

Inclusion criteria for the PPPD-placebo group:

• Diagnosis of PPPD;
• Recovery from COVID-19 infection or absence of previous infection (matched to the PPPD-glialia group).

Exclusion criteria for all PPPD-group:

• Presence of concurrent neurological and otological disorders other than PPPD;
• Pregnant women.

Inclusion criteria for the control group:

-Previous COVID-19 infection (matched for timing to the PPPD-glialia group).

Exclusion criteria for the control group:

• Presence of neurological and otological disorders;
• Pregnant women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

30 participants in 3 patient groups, including a placebo group

Glialia

Experimental group

Description:

Participants in the PPPD-Glialia group must be between the ages of 18 and 65 years and have a confirmed diagnosis of Persistent Perceptual Postural Dizziness (PPPD). They must also either have recovered from a COVID-19 infection or have no history of such an infection. Individuals with concurrent neurological or otological disorders, as well as pregnant women, will be excluded from this group.

Treatment:

Other: Glialia

Placebo

Placebo Comparator group

Description:

Participants in the PPPD-Glialia group must be between the ages of 18 and 65 years and have a confirmed diagnosis of Persistent Perceptual Postural Dizziness (PPPD). They must also either have recovered from a COVID-19 infection or have no history of such an infection. Individuals with concurrent neurological or otological disorders, as well as pregnant women, will be excluded from this group.

Treatment:

Other: Placebo

Control group

Other group

Description:

The Control Group will consist of individuals aged between 18 and 65 years who have a previous history of COVID-19 infection, matched for timing with the PPPD-Glialia group. Exclusion criteria for this group will also include the presence of any neurological or otological disorders and pregnancy, ensuring that the results are focused on the impact of the Glialia supplement in the context of PPPD and recovery from COVID-19.

Treatment:

Other: Control