2024-514222-24-00招募中4 期
Randomized, placebo-controlled, double-blind study to evaluate the efficacy of 2LEBV® and 2LXFS® on asthenia in patients with an EBV infection
Labo'Life Belgium, Labo'Life Belgium10 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2024年6月3日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 88
- 试验地点
- 10
- 主要终点
- The general fatigue scale of the MFI-20 questionnaire at the end of the treatment (6-month visit - V4)
研究概览
简要总结
Comparison of the efficacy of the treatment on fatigue severity at the end of the treatment between the 2LEBV® or the 2LXFS®/2LEBV® group versus the placebo group
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patient, male or female, aged 12 years and older, - Patient with significant 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, conjunctivitis, sensitive cervical or axillary lymph nodes, erythematous and swollen tonsils, 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 parent/legal representative if necessary) agrees to perform serology for the study, - Patient (and parent/legal representative if necessary) agrees to perform lymphocytes typing for the study, - Patient (and parent/legal representative if necessary) having the faculties to understand and respect the constraints of the study, - Signature of the Informed Consent Form by the patient (and parent/legal representative if necessary) - Patient who has a positive serology for EBV (IgG and/or IgM positive)
排除标准
- •Patient who has received any treatment with the 2LEBV® or 2LXFS®, - Patient who has received any homeopathic treatment in the previous 2 months prior to the study, - Patient under immunosuppressive treatment, - Patient undergoing treatment for psychiatric disorders, - Patient having received immunotherapy or micro-immunotherapy during the last 3 months, - Patient presenting a galactose intolerance, a Lapp lactase deficiency or a glucose-galactose malabsorption syndrome (rare genetic diseases), - Pregnant or breastfeeding woman, - Patient who participated in a clinical study in the previous 2-months period, - Patient (and/or parent/legal representative if necessary) who is not sufficiently motivated to engage on the total study follow-up period, or likely to travel or move before the end of the study, - Patient with severe immunodeficiency disease requiring long term treatment (*) or patients under chemotherapy or radiotherapy, - Patient under homeopathic or phytotherapy treatment, - Patient addicted to or using recreational drugs, - Patient under guardianship and/or curatorship.
结局指标
主要结局
The general fatigue scale of the MFI-20 questionnaire at the end of the treatment (6-month visit - V4)
The general fatigue scale of the MFI-20 questionnaire at the end of the treatment (6-month visit - V4)
次要结局
- - Physical fatigue, reduced activity, reduced motivation and mental fatigue scales on the MFI-20 questionnaire at V4, - 5 scales on the MFI-20 questionnaire at V3 and V5
- - Other EBV infection-related symptoms: Long-lasting exhaustion even after light exertion, subfebrile state, fever, loss of appetite, nausea, angina, conjunctivitis, 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 at V3, V4 and V5
- - Lymphocytes typing and immune status (normo, hypo or hyperactive immune system) at V1, V3, V4 and V5, - IgG anti-EA, anti-VCA, anti-EBNA and IgM anti-VCA at V0, V1 and V4, - Safety: Occurrence of Adverse Events (AEs) and Severe Adverse Events (SAEs), considered as related or not to the study drug.
研究者
Charlotte Bolle (Clinical Project Manager)
Scientific
Labo'Life Belgium
研究点 (10)
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