NCT04308278

Study to Evaluate the Efficacy of 2LEBV® and 2LXFS® on Asthenia in Patients With an Epstein-Barr Virus Infection

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Labo'Life · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• EBV Infection

Interventions

Type	Name	Description
DRUG	2LEBV® / 2LXFS®	The treatment schema consists in taking the content of one capsule a day, 15-30 minutes before breakfast, on an empty stomach, 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 6 months of continuous intake of the content of 1 capsule/day.
DRUG	Placebo	The treatment schema consists in taking the content of one capsule a day, 15-30 minutes before breakfast, on an empty stomach, 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 6 months of continuous intake of the content of 1 capsule/day.

Timeline

• Start date: 2021-01-22
• Primary completion: 2026-08-22
• Completion: 2026-08-30
• First posted: 2020-03-16
• Last updated: 2024-10-30

Locations

12 sites across 1 country: Belgium