Randomized, Placebo-controlled, Double Blind Study to Evaluate the Efficacy of 2LEBV® and 2LXFS® on Asthenia in Patients With an Epstein-Barr Virus Infection.

Who is this study for? Child to adult patients with Epstein-Barr Virus Infection
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Worldwide, 95% of adults are infected with Epstein-Barr Virus (EBV). These infections may cause different diseases. In most cases, EBV infection is asymptomatic because of a highly effective host immune response. Some individuals develop infectious mononucleosis (a self-limiting lymphoproliferative disorder in adolescents and young adults that is considered to be the primary infection), while others develop chronic fatigue syndrome, EBV-associated lymphoid, or epithelial malignancies. Today, there is no available treatment to treat and destroy EBV. The treatment is essentially symptomatic (treatment of the symptoms and not of the virus itself) with analgesics for pain for example. The studied drugs are 2LEBV® and 2LXFS®, from Labo'Life company, and the treatment schema is the same for the two drugs: it consists in taking the content of one capsule per day, sequentially, according to capsules' numerical order: 1 through 10. When capsule number 10 is taken, capsule 1 of the next blister should be taken on the next day to continue the treatment. The duration of treatment will be of 6 months of continuous intake of the content of 1 capsule/day. The aim of this study is to provide additional information on effectiveness on the 2LEBV® and 2LXFS®in the treatment of EBV chronic and acute infections, and in particular to demonstrate their effectiveness versus placebo in the reduction of asthenia and other symptoms in EBV infection.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• \- Patient who have a positive serology for EBV (IgG and/or IgM positive).

Locations
Other Locations
Belgium
Private Practice
RECRUITING
Aartselaar
Private Practice
TERMINATED
Boortmeerbeek
Private practice
RECRUITING
Brussels
Private Practice
RECRUITING
Brussels
Private Practice
RECRUITING
Brussels
Private Practice
RECRUITING
Ghent
Private Practice
WITHDRAWN
Jette
Private Practice
WITHDRAWN
Limal
Private practice
RECRUITING
Marche-en-famenne
Cabinet privé
RECRUITING
Schoten
Private practice
RECRUITING
Stavelot
Private practice
RECRUITING
Waregem
Contact Information
Primary
Charlotte BOLLE
charlotte.bolle@labolife.com
497 49 13 74
Backup
Laura FERTE
laura.ferte@labolife.com
499 71 79 64
Time Frame
Start Date: 2021-01-22
Estimated Completion Date: 2026-08-30
Participants
Target number of participants: 88
Treatments
Experimental: 2LEBV® / 2LXFS®
6 months of treatment
Placebo_comparator: Placebo
6 months of treatment
Authors
Maria-Magdalena HAEMELS
Related Therapeutic Areas
Sponsors
Leads: Labo'Life

This content was sourced from clinicaltrials.gov