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Randomized, placebo-controlled, double-blind study to evaluate the efficacy of 2LEBV® and 2LXFS® on asthenia in patients with an EBV infection
EU CTIS ID: 2024-514222-24-00
What this study is testing
Comparison of the efficacy of the treatment on fatigue severity at the end of the treatment between the 2LEBV® or the 2LXFS®/2LEBV® group versus the placebo group
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - Patient, male or female, aged 12 years and older, - Patient with significant fatigue for 1 month or more, - Patient with at least two other symptoms among the following: Long-lasting exhaustion even after light exertion, subfebrile state, fever, loss of appetite, nausea, angina, conjunctivitis, sensitive cervical or axillary lymph nodes, erythematous and swollen tonsils, headaches, sore throat, myalgia, muscular weakness, arthralgia, splenomegaly, visual disorders, memory disorders, attention deficit disorders, sleep disorders, gastrointestinal disorders, breathing disorders, cardiovascular disorders, - Patient (and parent/legal representative if necessary) agrees to perform serology for the study, - Patient (and parent/legal representative if necessary) agrees to perform lymphocytes typing for the study, - Patient (and parent/legal representative if necessary) having the faculties to understand and respect the constraints of the study, - Signature of the Informed Consent Form by the patient (and parent/legal representative if necessary) - Patient who has a positive serology for EBV (IgG and/or IgM positive)
You likely can't join if
- - Patient who has received any treatment with the 2LEBV® or 2LXFS®, - Patient who has received any homeopathic treatment in the previous 2 months prior to the study, - Patient under immunosuppressive treatment, - Patient undergoing treatment for psychiatric disorders, - Patient having received immunotherapy or micro-immunotherapy during the last 3 months, - Patient presenting a galactose intolerance, a Lapp lactase deficiency or a glucose-galactose malabsorption syndrome (rare genetic diseases), - Pregnant or breastfeeding woman, - Patient who participated in a clinical study in the previous 2-months period, - Patient (and/or parent/legal representative if necessary) who is not sufficiently motivated to engage on the total study follow-up period, or likely to travel or move before the end of the study, - Patient with severe immunodeficiency disease requiring long term treatment (*) or patients under chemotherapy or radiotherapy, - Patient under homeopathic or phytotherapy treatment, - Patient addicted to or using recreational drugs, - Patient under guardianship and/or curatorship.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.