NCT04308278 Study to Evaluate the Efficacy of 2LEBV® and 2LXFS® on Asthenia in Patients With an Epstein-Barr Virus Infection
| NCT ID | NCT04308278 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Labo'Life |
| Condition | EBV Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 88 participants |
| Start Date | 2021-01-22 |
| Primary Completion | 2028-08-22 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 88 participants in total. It began in 2021-01-22 with a primary completion date of 2028-08-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Worldwide, 95% of adults are infected with Epstein-Barr Virus (EBV). These infections may cause different diseases. In most cases, EBV infection is asymptomatic because of a highly effective host immune response. Some individuals develop infectious mononucleosis (a self-limiting lymphoproliferative disorder in adolescents and young adults that is considered to be the primary infection), while others develop chronic fatigue syndrome, EBV-associated lymphoid, or epithelial malignancies. Today, there is no available treatment to treat and destroy EBV. The treatment is essentially symptomatic (treatment of the symptoms and not of the virus itself) with analgesics for pain for example. The studied drugs are 2LEBV® and 2LXFS®, from Labo'Life company, and the treatment schema is the same for the two drugs: it consists in taking the content of one capsule per day, sequentially, according to capsules' numerical order: 1 through 10. When capsule number 10 is taken, capsule 1 of the next blister should be taken on the next day to continue the treatment. The duration of treatment will be of 6 months of continuous intake of the content of 1 capsule/day. The aim of this study is to provide additional information on effectiveness on the 2LEBV® and 2LXFS®in the treatment of EBV chronic and acute infections, and in particular to demonstrate their effectiveness versus placebo in the reduction of asthenia and other symptoms in EBV infection.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04308278 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying EBV Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04308278 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04308278 currently recruiting?
Yes, NCT04308278 is actively recruiting participants. Contact the research team at charlotte.bolle@labolife.com for enrollment information.
Where is the NCT04308278 trial being conducted?
This trial is being conducted at Heule, Belgium, Aartselaar, Belgium, Brussels, Belgium, Ghent, Belgium and 4 additional locations.
Who is sponsoring the NCT04308278 clinical trial?
NCT04308278 is sponsored by Labo'Life. The trial plans to enroll 88 participants.