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

Primary Purpose

EBV Infection

Status

Recruiting

Phase

Phase 4

Locations

Belgium

Study Type

Interventional

Intervention

2LEBV® / 2LXFS®

Placebo

About this trial

This is an interventional treatment trial for EBV Infection

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

2LEBV® / 2LXFS®

Placebo

Arm Description

6 months of treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Comparison of the evolution of the lymphocytes typing between the 2LEBV® and 2LXFS®/2LEBV® group versus the placebo group.

Safety: occurence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug.

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.

Full Information

NCT ID

NCT04308278

First Posted

March 11, 2020

Last Updated

October 6, 2023

Sponsor

Labo'Life

1. Study Identification

Unique Protocol Identification Number

NCT04308278

Brief Title

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

Acronym

EBVAST

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.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 22, 2021 (Actual)

Primary Completion Date

August 22, 2024 (Anticipated)

Study Completion Date

August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Labo'Life

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

EBV Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

2LEBV® / 2LXFS®

Arm Type

Experimental

Arm Description

6 months of treatment

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

6 months of treatment

Intervention Type

Drug

Intervention Name(s)

2LEBV® / 2LXFS®

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Primary Outcome Measure Information:

Title

Measure of the general fatigue scale of the Multidiensional Fatigue Inventory-20 (MFI-20) questionnaire at the end of the treatment.

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Description

Time Frame

6 months

Title

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.

Description

Time Frame

3 months

Title

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.

Description

Time Frame

12 months

Title

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

Title

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

Title

Comparison of the evolution of the lymphocytes typing between the 2LEBV® and 2LXFS®/2LEBV® group versus the placebo group.

Time Frame

12 months

Title

Safety: occurence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug.

Time Frame

6 months

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Charlotte BOLLE

Phone

497 49 13 74

Ext

+32

charlotte.bolle@labolife.com

First Name & Middle Initial & Last Name or Official Title & Degree

Laura FERTE

Phone

499 71 79 64

laura.ferte@labolife.com

Facility Information:

Facility Name

Private Practice

City

Aartselaar

ZIP/Postal Code

2630

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ilse BUNTINX, Dr

First Name & Middle Initial & Last Name & Degree

Ilse BUNTINX, Dr

Facility Name

Private Practice

City

Boortmeerbeek

ZIP/Postal Code

3190

Country

Belgium

Individual Site Status

Terminated

Facility Name

Private Practice

City

Brussels

ZIP/Postal Code

1040

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eric BEETH, Dr

First Name & Middle Initial & Last Name & Degree

Eric BEETH, Dr

Facility Name

Private practice

City

Brussels

ZIP/Postal Code

1040

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vania SIDEROVA

First Name & Middle Initial & Last Name & Degree

Vania SIDEROVA, Dr

Facility Name

Private Practice

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jan-Jaap HUYSMAN, Dr

First Name & Middle Initial & Last Name & Degree

Jan-Jaap HUYSMAN, Dr

Facility Name

Private Practice

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maarteen AVET, Dr

First Name & Middle Initial & Last Name & Degree

Maarteen AVET, Dr

Facility Name

Private Practice

City

Jette

ZIP/Postal Code

1090

Country

Belgium

Individual Site Status

Withdrawn

Facility Name

Private Practice

City

Limal

ZIP/Postal Code

1300

Country

Belgium

Individual Site Status

Withdrawn

Facility Name

Private practice

City

Marche-en-Famenne

ZIP/Postal Code

6900

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Helene PD Saintmar

First Name & Middle Initial & Last Name & Degree

Helene Saintmar, Dr

Facility Name

Cabinet privé

City

Schoten

ZIP/Postal Code

2900

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anne-Léontine PD Fierlafijn, Principal

First Name & Middle Initial & Last Name & Degree

Anne-Léontine FIERLAFIJN, Dr

Facility Name

Private practice

City

Stavelot

ZIP/Postal Code

4790

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eric Menard

First Name & Middle Initial & Last Name & Degree

Eric Menard, Dr

Facility Name

Private practice

City

Waregem

ZIP/Postal Code

8790

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thijs LONCKE, Dr

First Name & Middle Initial & Last Name & Degree

Thijs LONCKE, Dr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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

EBV Infection

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial