Study to Evaluate the Efficacy of 2LEBV® and 2LXFS® on Asthenia in Patients With an Epstein-Barr Virus Infection
NCT ID: NCT04308278
Last Updated: 2024-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
88 participants
INTERVENTIONAL
2021-01-22
2026-08-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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2LEBV® / 2LXFS®
6 months of treatment
2LEBV® / 2LXFS®
The treatment schema consists in taking the content of one capsule a day, 15-30 minutes before breakfast, on an empty stomach, 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 6 months of continuous intake of the content of 1 capsule/day.
Placebo
6 months of treatment
Placebo
The treatment schema consists in taking the content of one capsule a day, 15-30 minutes before breakfast, on an empty stomach, 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 6 months of continuous intake of the content of 1 capsule/day.
Interventions
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2LEBV® / 2LXFS®
The treatment schema consists in taking the content of one capsule a day, 15-30 minutes before breakfast, on an empty stomach, 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 6 months of continuous intake of the content of 1 capsule/day.
Placebo
The treatment schema consists in taking the content of one capsule a day, 15-30 minutes before breakfast, on an empty stomach, 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 6 months of continuous intake of the content of 1 capsule/day.
Eligibility Criteria
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Inclusion Criteria
* 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).
\- Patient who have a positive serology for EBV (IgG and/or IgM positive).
Exclusion Criteria
* 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.
12 Years
ALL
No
Sponsors
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Labo'Life
INDUSTRY
Responsible Party
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Locations
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Private Practice
Aartselaar, , Belgium
Private Practice
Boortmeerbeek, , Belgium
Private Practice
Brussels, , Belgium
Private practice
Brussels, , Belgium
Private Practice
Brussels, , Belgium
Private Practice
Ghent, , Belgium
Private Practice
Jette, , Belgium
Private Practice
Limal, , Belgium
Private practice
Marche-en-Famenne, , Belgium
Cabinet privé
Schoten, , Belgium
Private practice
Stavelot, , Belgium
Private practice
Waregem, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Ilse BUNTINX, Dr
Role: primary
Eric BEETH, Dr
Role: primary
Vania SIDEROVA
Role: primary
Jan-Jaap HUYSMAN, Dr
Role: primary
Maarteen AVET, Dr
Role: primary
Helene PD Saintmar
Role: primary
Anne-Léontine PD Fierlafijn, Principal
Role: primary
Eric Menard
Role: primary
Thijs LONCKE, Dr
Role: primary
Other Identifiers
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LLB-2019-03
Identifier Type: -
Identifier Source: org_study_id
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