Actively Recruiting
Randomized, Placebo-controlled, Double Blind 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
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Epstein-Barr Virus (EBV) infects most adults worldwide and can cause various diseases including infectious mononucleosis and chronic fatigue syndrome. This trial evaluates two drugs, 2LEBV and 2LXFS , to study their effects on reducing fatigue and other symptoms related to EBV infection. The study aims to provide new information on their effectiveness compared to placebo in treating EBV infections. Participants will take one capsule daily of either 2LEBV , 2LXFS , or placebo for six continuous months. Capsules are taken sequentially by number, one per day before breakfast on an empty stomach. The treatment follows a specific order from capsule 1 through 10, repeated continuously for the full treatment duration. During the study, participants will complete fatigue questionnaires called the Multidimensional Fatigue Inventory-20 (MFI-20) to measure general and specific types of fatigue. Researchers will also monitor other EBV symptoms, lymphocyte typing, and safety by tracking adverse events over six to twelve months. Participation involves regular assessments through the treatment period and beyond to evaluate the drugs' impact on fatigue and symptoms.
CONDITIONS
Brief 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 1 month or more
- At least two other symptoms such as long-lasting exhaustion, subfebrile state, fever, loss of appetite, nausea, angina, conjunctivitis, sensitive lymph nodes, erythematous and swollen tonsil, headaches, sore throat, myalgia, muscle weakness, arthralgia, splenomegaly, visual or memory disorders, attention deficit, sleep, gastrointestinal, breathing or cardiovascular disorders
- Positive serology for EBV (IgG and/or IgM positive)
- Agreement to perform serology and lymphocyte typing for the study
- Ability to understand and comply with study requirements
- Signed informed consent
You will not qualify if you...
- Previous treatment with 2LEBV� or 2LXFS�
- Homeopathic treatment in the 2 months before the study
- Current immunosuppressive treatment
- Treatment for psychiatric disorders
- Immunotherapy or micro-immunotherapy in the last 3 months
- Known lactose intolerance
- Pregnant or breastfeeding women
- Participation in another clinical study in the last 2 months
- Insufficient motivation or planned travel before study end
- Severe immunodeficiency needing long-term treatment, chemotherapy, or radiotherapy
- Current homeopathic or phytotherapy treatment
- Addiction or use of recreational drugs
- Under guardianship or curatorship
- Important renal or respiratory insufficiency, transplant, HIV/AIDS, or terminal cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants take one capsule daily, 15-30 minutes before breakfast on an empty stomach, sequentially numbered from 1 to 10, continuing for 6 months of continuous intake.
Visits scheduled regularly during the 6 months of treatment
Duration - Up to 12 months
Participants are monitored for efficacy and safety outcomes up to 12 months after starting treatment.
Visits at 3, 6, and 12 months for assessments
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
L
Laura FERTE
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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