INTERFERON ALFA; DEOXYRIBONUCLEIC ACID; INTERFERON GAMMA; INTERLEUKIN-1; INTERLEUKIN-2; RIBONUCLEIC ACID; SPECIFIC NUCLEIC ACID SNA-XFSA; SPECIFIC NUCLEIC ACID SNA-XFSB; SPECIFIC NUCLEIC ACID SNA-XFSC; RIBONUCLEIC ACID K10; RIBONUCLEIC ACID K30; TUMOR NECROSIS FACTOR-ALPHA for Epstein-Barr virus infection

Inclusion criteria

• {"criterion_text":"- Patient, male or female, aged 12 years and older\n- Patient with significant fatigue for 1 month or more\n- 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\n- Patient (and parent/legal representative if necessary) agrees to perform serology for the study\n- Patient (and parent/legal representative if necessary) agrees to perform lymphocytes typing for the study\n- Patient (and parent/legal representative if necessary) having the faculties to understand and respect the constraints of the study\n- Signature of the Informed Consent Form by the patient (and parent/legal representative if necessary)\n- Patient who has a positive serology for EBV (IgG and/or IgM positive)"}

Exclusion criteria

• {"criterion_text":"- Patient who has received any treatment with the 2LEBV® or 2LXFS®\n- Patient who has received any homeopathic treatment in the previous 2 months prior to the study\n- Patient under immunosuppressive treatment\n- Patient undergoing treatment for psychiatric disorders\n- Patient having received immunotherapy or micro-immunotherapy during the last 3 months\n- Patient presenting a galactose intolerance, a Lapp lactase deficiency or a glucose-galactose malabsorption syndrome (rare genetic diseases)\n- Pregnant or breastfeeding woman\n- Patient who participated in a clinical study in the previous 2-months period\n- 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\n- Patient with severe immunodeficiency disease requiring long term treatment (*) or patients under chemotherapy or radiotherapy\n- Patient under homeopathic or phytotherapy treatment\n- Patient addicted to or using recreational drugs\n- Patient under guardianship and/or curatorship"}

Primary endpoints

• {"endpoint_text":"- The general fatigue scale of the MFI-20 questionnaire at the end of the treatment (6-month visit - V4)","definition_or_measurement_approach":"Score on the general fatigue scale of the MFI-20 questionnaire measured at the end of treatment (6-month visit, V4)."}

Secondary endpoints

• {"endpoint_text":"- Physical fatigue, reduced activity, reduced motivation and mental fatigue scales on the MFI-20 questionnaire at V4, - 5 scales on the MFI-20 questionnaire at V3 and V5","definition_or_measurement_approach":"Subscale scores of the MFI-20 (physical fatigue, reduced activity, reduced motivation, mental fatigue) at V4 and the five MFI-20 scales at V3 (3 months) and V5 (12 months)."}
• {"endpoint_text":"- Other EBV infection-related symptoms: 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 tonsil, headaches, sore throat, myalgia, muscular weakness, arthralgia, splenomegaly, visual disorders, memory disorders, attention deficit disorders, sleep disorders, gastrointestinal disorders, breathing disorders, cardiovascular disorders at V3, V4 and V5","definition_or_measurement_approach":"Assessment of listed EBV-related symptoms and their presence/duration at visits V3 (3 months), V4 (6 months) and V5 (12 months)."}
• {"endpoint_text":"- Lymphocytes typing and immune status (normo, hypo or hyperactive immune system) at V1, V3, V4 and V5, - IgG anti-EA, anti-VCA, anti-EBNA and IgM anti-VCA at V0, V1 and V4, - Safety: Occurrence of Adverse Events (AEs) and Severe Adverse Events (SAEs), considered as related or not to the study drug.","definition_or_measurement_approach":"Laboratory measures: lymphocyte typing and immune status at V1/V3/V4/V5; serology IgG/IgM panels at V0/V1/V4; safety assessed by recording AEs and SAEs and causality attribution."}

Belgium

Earliest CTIS Part Ii Submission Date

30-04-2024

Latest Decision Or Authorization Date

03-06-2024

Processing Time Days

34

Number Of Sites

10

Number Of Participants

88

Primary sponsor

Full Name

Labo'Life Belgium

Organisation Type

Pharmaceutical company

Country Of Registered Address

Belgium