A new attack on Epstein-Barr fatigue: two capsules put to the test

NCT ID NCT04308278

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests whether two experimental capsules, 2LEBV and 2LXFS, can reduce fatigue and other symptoms in people with an Epstein-Barr virus infection. Participants take one capsule daily for six months, either one of the study drugs or a placebo. The study measures changes in fatigue using a standard questionnaire, comparing the drug groups against placebo. The goal is to see if these capsules offer a new way to manage the debilitating tiredness that often follows EBV infection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Two experimental oral capsules, 2LEBV and 2LXFS, taken daily for six months
What this could lead to
If effective, these capsules could offer a new way to reduce chronic fatigue and other symptoms in people with Epstein-Barr virus infection, where current care only manages symptoms.
What could go wrong
This is a mid-stage trial with a modest number of participants, and the capsules may not outperform a placebo. The treatment is experimental, and its safety and effectiveness are not yet established.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 88 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2021

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cabinet privé

    RECRUITING

    Schoten, 2900, Belgium

  • Private Practice

    RECRUITING

    Aartselaar, 2630, Belgium

  • Private Practice

    RECRUITING

    Brussels, 1200, Belgium

  • Private Practice

    RECRUITING

    Ghent, 9000, Belgium

  • Private practice

    RECRUITING

    Marche-en-Famenne, 6900, Belgium

  • Private practice

    RECRUITING

    Stavelot, 4790, Belgium

  • Private practice

    RECRUITING

    Waregem, 8790, Belgium

  • Private practice of Dr Pieterjan DEBBAUT

    ACTIVE_NOT_RECRUITING

    Heule, Kortrijk, 8501, Belgium

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