We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Evaluate the Efficacy of 2LEBV® and 2LXFS® on Asthenia in Patients With an Epstein-Barr Virus Infection (EBVAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04308278
Recruitment Status : Recruiting
First Posted : March 16, 2020
Last Update Posted : December 23, 2022
Sponsor:
Information provided by (Responsible Party):
Labo'Life

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
EBV Infection Drug: 2LEBV® / 2LXFS® Drug: Placebo Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Placebo-controlled, Double Blind Study to Evaluate the Efficacy of 2LEBV® and 2LXFS® on Asthenia in Patients With an Epstein-Barr Virus Infection.
Actual Study Start Date : January 22, 2021
Estimated Primary Completion Date : August 22, 2023
Estimated Study Completion Date : August 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 2LEBV® / 2LXFS®
6 months of treatment
 Drug: 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 Comparator: Placebo
6 months of treatment
 Drug: 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Measure of the general fatigue scale of the Multidiensional Fatigue Inventory-20 (MFI-20) questionnaire at the end of the treatment. [ Time Frame: 6 months ]

    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.



Secondary Outcome Measures :
  1. 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 [ Time Frame: 6 months ]

    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.


  2. 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. [ Time Frame: 3 months ]

    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. 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. [ Time Frame: 12 months ]

    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.


  4. 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. [ Time Frame: 6 months ]
  5. 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. [ Time Frame: 12 months ]
  6. Comparison of the evolution of the lymphocytes typing between the 2LEBV® and 2LXFS®/2LEBV® group versus the placebo group. [ Time Frame: 12 months ]
  7. Safety: occurence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug. [ Time Frame: 6 months ]
  8. 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. [ Time Frame: 3 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04308278


Contacts
Layout table for location contacts
Contact: Bernadette CRASSET 491 39 07 38 ext +32 bernadette.crasset@labolife.com

Locations
Layout table for location information
Belgium
Private Practice Recruiting
Aartselaar, Belgium, 2630
Contact: Ilse BUNTINX, Dr         
Principal Investigator: Ilse BUNTINX, Dr         
Private Practice Recruiting
Boortmeerbeek, Belgium, 3190
Contact: Maria-Magdalena HAEMELS, Dr         
Principal Investigator: Maria-Magdalena HAEMELS, Dr         
Private Practice Recruiting
Brussels, Belgium, 1040
Contact: Eric BEETH, Dr         
Principal Investigator: Eric BEETH, Dr         
Private practice Recruiting
Brussels, Belgium, 1040
Contact: Vania SIDEROVA         
Principal Investigator: Vania SIDEROVA, Dr         
Private Practice Recruiting
Bruxelles, Belgium, 1200
Contact: Jan-Jaap HUYSMAN, Dr         
Principal Investigator: Jan-Jaap HUYSMAN, Dr         
Private Practice Recruiting
Gent, Belgium, 9000
Contact: Maarteen AVET, Dr         
Principal Investigator: Maarteen AVET, Dr         
Private Practice Recruiting
Jette, Belgium, 1090
Contact: Quirico BLONDA, Dr         
Principal Investigator: Quirico BLONDA, Dr         
Private Practice Recruiting
Limal, Belgium, 1300
Contact: Quirico BLONDA, Dr         
Principal Investigator: Quirico BLONDA, Dr         
Private practice Recruiting
Marche-en-Famenne, Belgium, 6900
Contact: Helene PD Saintmar         
Principal Investigator: Helene Saintmar, Dr         
Private Practice Not yet recruiting
Nivelles, Belgium, 1400
Contact: Véronique BAUDOUX, Dr         
Principal Investigator: Véronique BAUDOUX, Dr         
Cabinet privé Recruiting
Schoten, Belgium, 2900
Contact: Anne-Léontine PD Fierlafijn, Principal         
Principal Investigator: Anne-Léontine FIERLAFIJN, Dr         
Private practice Recruiting
Stavelot, Belgium, 4790
Contact: Eric Menard         
Principal Investigator: Eric Menard, Dr         
Private practice Recruiting
Waregem, Belgium, 8790
Contact: Thijs LONCKE, Dr         
Principal Investigator: Thijs LONCKE, Dr         
Sponsors and Collaborators
Labo'Life
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Labo'Life
ClinicalTrials.gov Identifier: NCT04308278    
Other Study ID Numbers: LLB-2019-03
First Posted: March 16, 2020    Key Record Dates
Last Update Posted: December 23, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Infections
Communicable Diseases
Virus Diseases
Epstein-Barr Virus Infections
Asthenia
 Disease Attributes
Pathologic Processes
Herpesviridae Infections
DNA Virus Infections
Tumor Virus Infections