Evaluating 2LEBV® and 2LXFS® for fatigue in Epstein-Barr Virus patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the efficacy of two investigational drugs, 2LEBV® and 2LXFS®, in alleviating asthenia associated with Epstein-Barr Virus (EBV) infections. Participants aged 12 and older who have experienced fatigue for over a month and exhibit additional symptoms related to EBV will be enrolled. The treatment involves taking one capsule per day in a sequential order for a total of ten days, with a placebo group for comparison. The study seeks to provide a potential therapeutic option for managing symptoms of EBV infections, which currently lack effective treatments.

Why it matters

Who can join: the full rules

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).

Inclusion Criteria:

\- Patient who have a positive serology for EBV (IgG and/or IgM positive).

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.

Where it's running

• Private Practice
  Aartselaar, Belgium Recruiting
• Private Practice
  Brussels, Belgium Recruiting
• Private Practice
  Ghent, Belgium Recruiting
• Private practice
  Marche-en-Famenne, Belgium Recruiting
• Cabinet privé
  Schoten, Belgium Recruiting
• Private practice
  Stavelot, Belgium Recruiting

Study contacts

• Study coordinator: Charlotte BOLLE
• Email: charlotte.bolle@labolife.com
• Phone: 497 49 13 74

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.