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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2LEBV® / 2LXFS® | Experimental | 6 months of treatment |
|
| Placebo | Placebo Comparator | 6 months of treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2LEBV® / 2LXFS® | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of the general fatigue scale of the Multidiensional Fatigue Inventory-20 (MFI-20) questionnaire at the end of the treatment. | Multidiensional Fatigue Inventory-20 (MFI-20) questionnaire. 5 scales. Higher scores means worse outcome. General Fatigue dimension: Minimum value: 4. Maximum Value: 20. Physical fatigue dimension: Minimum value: 4. Maximum Value: 20. Reduced activity dimension: Minimum value: 4. Maximum Value: 20. Reduced motivation dimension: Minimum value: 4. Maximum Value: 20. Mental fatigue dimension: Minimum value: 4. Maximum Value: 20. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the efficacy of the treatment on physical fatigue, reduced activity, reduced motivation and mental fatigue scales on the MFI-20 questionnaire between the 2LEBV® or the 2LXFS®/2LEBV® group versus the placebo group | Multidiensional Fatigue Inventory-20 (MFI-20) questionnaire. 5 scales. Higher scores means worse outcome. Physical fatigue dimension: Minimum value: 4. Maximum Value: 20. Reduced activity dimension: Minimum value: 4. Maximum Value: 20. Reduced motivation dimension: Minimum value: 4. Maximum Value: 20. Mental fatigue dimension: Minimum value: 4. Maximum Value: 20. |
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Pré-Inclusion Criteria:
Inclusion Criteria:
- Patient who have a positive serology for EBV (IgG and/or IgM positive).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charlotte BOLLE | Contact | 497 49 13 74 | +32 | charlotte.bolle@labolife.com |
| Laura FERTE | Contact | 499 71 79 64 | laura.ferte@labolife.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private Practice | Recruiting | Aartselaar | 2630 | Belgium |
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|
| Placebo | Drug | 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. |
|
| 6 months |
| Comparison of the efficacy of the treatment on general fatigue and other dimensions of the MFI-20 questionnaire between the 2LEBV® and the 2LXFS®/2LEBV® group versus the placebo group. | Multidiensional Fatigue Inventory-20 (MFI-20) questionnaire. 5 scales. Higher scores means worse outcome. General Fatigue dimension: Minimum value: 4. Maximum Value: 20. Physical fatigue dimension: Minimum value: 4. Maximum Value: 20. Reduced activity dimension: Minimum value: 4. Maximum Value: 20. Reduced motivation dimension: Minimum value: 4. Maximum Value: 20. Mental fatigue dimension: Minimum value: 4. Maximum Value: 20. | 3 months |
| Comparison of the efficacy of the treatment on general fatigue and other dimensions of the MFI-20 questionnaire between the 2LEBV® and the 2LXFS®/2LEBV® group versus the placebo group. | Multidiensional Fatigue Inventory-20 (MFI-20) questionnaire. 5 scales. Higher scores means worse outcome. General Fatigue dimension: Minimum value: 4. Maximum Value: 20. Physical fatigue dimension: Minimum value: 4. Maximum Value: 20. Reduced activity dimension: Minimum value: 4. Maximum Value: 20. Reduced motivation dimension: Minimum value: 4. Maximum Value: 20. Mental fatigue dimension: Minimum value: 4. Maximum Value: 20. | 12 months |
| Comparisons of the efficacy of the treatment on others symptoms related to EBV infection and their duration between the 2LEBV® and 2LXFS®/2LEBV® group versus the placebo group. | 6 months |
| Comparisons of the efficacy of the treatment on others symptoms related to EBV infection and their duration between the 2LEBV® and 2LXFS®/2LEBV® group versus the placebo group. | 12 months |
| Comparison of the evolution of the lymphocytes typing between the 2LEBV® and 2LXFS®/2LEBV® group versus the placebo group. | 12 months |
| Safety: occurence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug. | 6 months |
| Comparisons of the efficacy of the treatment on others symptoms related to EBV infection and their duration between the 2LEBV® and 2LXFS®/2LEBV® group versus the placebo group. | 3 months |
| Private Practice | Terminated | Boortmeerbeek | 3190 | Belgium |
| Private Practice | Recruiting | Brussels | 1040 | Belgium |
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| Private practice | Recruiting | Brussels | 1040 | Belgium |
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| Private Practice | Recruiting | Brussels | 1200 | Belgium |
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| Private Practice | Recruiting | Ghent | 9000 | Belgium |
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| Private Practice | Withdrawn | Jette | 1090 | Belgium |
| Private Practice | Withdrawn | Limal | 1300 | Belgium |
| Private practice | Recruiting | Marche-en-Famenne | 6900 | Belgium |
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| Cabinet privé | Recruiting | Schoten | 2900 | Belgium |
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| Private practice | Recruiting | Stavelot | 4790 | Belgium |
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| Private practice | Recruiting | Waregem | 8790 | Belgium |
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| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
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