Randomized, placebo-controlled, double-blind study to evaluate the efficacy of 2LEBV® and 2LXFS® on asthenia in patients with an EBV infectio

Phase 1

• Conditions: Epstein-Barr Virus infection; MedDRA version: 21.0Level: LLTClassification code: 10056907Term: EBV antigen positive Class: 10022891; MedDRA version: 21.1Level: LLTClassification code: 10056906Term: EBV antibody positive Class: 10022891; MedDRA version: 20.0Level: LLTClassification code: 10014077Term: EBV infection Class: 10021881; MedDRA version: 23.1Level: LLTClassification code: 10014078Term: EBV infection reactivation Class: 10021881; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: CTIS2024-514222-24-00
• Lead Sponsor: abo'Life Belgium

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-15
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

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)

Exclusion Criteria

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified