Actively Recruiting
Study to Evaluate the Efficacy of 2LEBV® and 2LXFS® on Asthenia in Patients With an Epstein-Barr Virus Infection
Led by Labo'Life · Updated on 2024-10-30
88
Participants Needed
12
Research Sites
292 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study to Evaluate the Efficacy of 2LEBV® and 2LXFS® on Asthenia in Patients With an Epstein-Barr Virus Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 12 years and older
- Fatigue lasting for 1 month or more
- Presence of at least two symptoms such as long-lasting exhaustion, fever, loss of appetite, nausea, sore throat, headaches, muscle weakness, sleep disorders, or other listed symptoms
- Agreement to perform serology and lymphocyte typing for the study
- Ability to understand and comply with study requirements
- Signed informed consent form
- Positive serology for EBV (IgG and/or IgM positive)
You will not qualify if you...
- Previous treatment with 2LEBV�AE or 2LXFS�AE
- Use of homeopathic treatment within 2 months before the study
- Current immunosuppressive treatment
- Treatment for psychiatric disorders
- Immunotherapy or micro-immunotherapy in the last 3 months
- Known lactose intolerance
- Pregnancy or breastfeeding
- Participation in another clinical study within the past 2 months
- Lack of motivation or likelihood to move or travel before study completion
- Severe immunodeficiency requiring long-term treatment, chemotherapy, or radiotherapy
- Use of homeopathic or phytotherapy treatment currently
- Addiction to or use of recreational drugs
- Under guardianship or curatorship
- Important renal or respiratory insufficiency, transplant or graft recipients, HIV/AIDS, terminal cancer
AI-Screening
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Trial Site Locations
Total: 12 locations
1
Private Practice
Aartselaar, Belgium, 2630
Actively Recruiting
2
Private Practice
Boortmeerbeek, Belgium, 3190
Terminated
3
Private Practice
Brussels, Belgium, 1040
Actively Recruiting
4
Private practice
Brussels, Belgium, 1040
Actively Recruiting
5
Private Practice
Brussels, Belgium, 1200
Actively Recruiting
6
Private Practice
Ghent, Belgium, 9000
Actively Recruiting
7
Private Practice
Jette, Belgium, 1090
Withdrawn
8
Private Practice
Limal, Belgium, 1300
Withdrawn
9
Private practice
Marche-en-Famenne, Belgium, 6900
Actively Recruiting
10
Cabinet privé
Schoten, Belgium, 2900
Actively Recruiting
11
Private practice
Stavelot, Belgium, 4790
Actively Recruiting
12
Private practice
Waregem, Belgium, 8790
Actively Recruiting
Research Team
C
Charlotte BOLLE
CONTACT
L
Laura FERTE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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