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

Phase 1

• Conditions: Epstein-Barr Virus infection; MedDRA version: 20.0Level: LLTClassification code 10014077Term: EBV infectionSystem Organ Class: 100000004862; MedDRA version: 23.0Level: LLTClassification code 10014078Term: EBV infection reactivationSystem Organ Class: 100000004862; MedDRA version: 21.1Level: LLTClassification code 10056906Term: EBV antibody positiveSystem Organ Class: 100000004848; MedDRA version: 21.0Level: LLTClassification code 10056907Term: EBV antigen positiveSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-000085-42-BE
• Lead Sponsor: ABO'LIFE Belgium sprl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-29
• Last Update Posted: 10 June 2024

Recruitment & Eligibility

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

Inclusion Criteria

- Patients, 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, conjunctivis, 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/or parents if necessary) agrees to perform serology for the study,
-Patient (and parents if necessary) agrees to perform lymphocyte typing for the study,
-Patients (and 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 parents if necessary).
-Patient who have a positive serology for EBV (IgG and/or IgM positive).
Are the trial subjects under 18? yes
Number of subjects for this age range: 44
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

-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.

Study & Design

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