NCT04308278RecruitingPhase 4
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.
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 88 (estimated)
- First submitted
- 11 Mar 2020
- Start date
- 22 Jan 2021
- Primary completion date
- 22 Aug 2028
- Lead sponsor
- Labo'Life
- NCT number
- NCT04308278
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 88
- From 22 Jan 2021 to the primary completion date, 22 Aug 2028
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient who have received any treatment with the 2LEBV® or 2LXFS®,
- Patients who have received any homeopathic treatment in the previous 2 months prior to the study,
- Patients having received immunotherapy or micro-immunotherapy during the last 3 months,
- Patients who participated in a clinical study in the previous 2-months period,
- Patients addicted to or using recreational drugs,
Other illness
- Patient undergoing treatment for psychiatric disorders,
- Patients with severe immunodeficiency disease requiring long term treatment (\*) or patients under chemotherapy or radiotherapy,
- Patient under guardianship and/or curatorship, (\*) important renal or respiratory insufficiency, transplanted or grafted patients, HIV/AIDS, terminal cancer.
Other
- Patients under immunosuppressive treatment,
- Patients with known lactose intolerance,
- Pregnant or breastfeeding women,
- Patients (and/or parents of patients if necessary) who are not sufficiently motivated to engage on the total study follow-up period, or likely to travel or to move before the end of the study,
- Patients under homeopathic or phytotherapy treatment,
Who the study is looking for
- \- Patient who have a positive serology for EBV (IgG and/or IgM positive).
Criteria the registry did not label
- Pre-Inclusion Criteria:
- Patients, male or female, aged 12 years and older,
- Patient with 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, conjunctivis, sensitive cervical or axillary lymph nodes, erythematous and swollen tonsil, 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/or parents if necessary) agrees to perform serology for the study,
- Patient (and/or parents if necessary) agrees to perform lymphocyte typing for the study during the pre-inclusion visit,
- Patients (and/or parents if necessary) having the faculties to understand and respect the constraints of the study,
- Signature of the Informed Consent Form by the patient (and/or parents if necessary).
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Private Practice Coordinator of this site? Confirm its status | Aartselaar | Belgium | Recruiting |
| Private Practice Coordinator of this site? Confirm its status | Brussels | Belgium | Recruiting |
| Private Practice Coordinator of this site? Confirm its status | Ghent | Belgium | Recruiting |
| Private practice of Dr Pieterjan DEBBAUT Coordinator of this site? Confirm its status | Heule | Belgium | Active, not recruiting |
| Private practice Coordinator of this site? Confirm its status | Marche-en-Famenne | Belgium | Recruiting |
| Cabinet privé Coordinator of this site? Confirm its status | Schoten | Belgium | Recruiting |
| Private practice Coordinator of this site? Confirm its status | Stavelot | Belgium | Recruiting |
| Private practice Coordinator of this site? Confirm its status | Waregem | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.