Status:
RECRUITING
Study to Evaluate the Efficacy of 2LEBV® and 2LXFS® on Asthenia in Patients With an Epstein-Barr Virus Infection
Lead Sponsor:
Labo'Life
Conditions:
EBV Infection
Eligibility:
All Genders
12+ years
Phase:
PHASE4
Brief 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 immu...
Eligibility Criteria
Inclusion
- Pré-
- 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).
- \- Patient who have a positive serology for EBV (IgG and/or IgM positive).
Exclusion
- 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 under immunosuppressive treatment,
- Patient undergoing treatment for psychiatric disorders,
- Patients having received immunotherapy or micro-immunotherapy during the last 3 months,
- Patients with known lactose intolerance,
- Pregnant or breastfeeding women,
- Patients who participated in a clinical study in the previous 2-months period,
- 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 with severe immunodeficiency disease requiring long term treatment (\*) or patients under chemotherapy or radiotherapy,
- Patients under homeopathic or phytotherapy treatment,
- Patients addicted to or using recreational drugs,
- Patient under guardianship and/or curatorship, (\*) important renal or respiratory insufficiency, transplanted or grafted patients, HIV/AIDS, terminal cancer.
Key Trial Info
Start Date :
January 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2026
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT04308278
Start Date
January 22 2021
End Date
August 30 2026
Last Update
October 30 2024
Active Locations (12)
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1
Private Practice
Aartselaar, Belgium, 2630
2
Private Practice
Boortmeerbeek, Belgium, 3190
3
Private Practice
Brussels, Belgium, 1040
4
Private practice
Brussels, Belgium, 1040