Evaluating 2LEBV® and 2LXFS® for fatigue in Epstein-Barr Virus patients
Randomized, Placebo-controlled, Double Blind Study to Evaluate the Efficacy of 2LEBV® and 2LXFS® on Asthenia in Patients With an Epstein-Barr Virus Infection.
This study is testing two new medications to see if they can help people aged 12 and older who have been feeling very tired due to Epstein-Barr Virus infections.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Labo'Life Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 12 sites (Aartselaar and 11 other locations) |
| Trial ID | NCT04308278 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 12 and older who have experienced fatigue for at least one month along with other EBV-related symptoms.
Not a fit: Patients who do not exhibit fatigue or related symptoms of EBV infection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients suffering from fatigue related to EBV infections.
How similar studies have performed: While there is limited data on the specific drugs being tested, the approach of targeting symptoms of EBV infections has been explored in other studies, though this specific methodology is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Pré-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 this trial is running
Aartselaar and 11 other locations
- Private Practice — Aartselaar, Belgium (Recruiting)
- Private Practice — Boortmeerbeek, Belgium (Terminated)
- Private Practice — Brussels, Belgium (Recruiting)
- Private practice — Brussels, Belgium (Recruiting)
- Private Practice — Brussels, Belgium (Recruiting)
- Private Practice — Ghent, Belgium (Recruiting)
- Private Practice — Jette, Belgium (Withdrawn)
- Private Practice — Limal, Belgium (Withdrawn)
- Private practice — Marche-en-Famenne, Belgium (Recruiting)
- Cabinet privé — Schoten, Belgium (Recruiting)
- Private practice — Stavelot, Belgium (Recruiting)
- Private practice — Waregem, Belgium (Recruiting)
Study contacts
- Study coordinator: Charlotte BOLLE
- Email: charlotte.bolle@labolife.com
- Phone: 497 49 13 74
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.