NCT07168772招募中不适用
The Effect of a Probiotic Administration as an add-on Treatment in Multiple Sclerosis: a Randomized, Double-blind, Placebo-controlled Clinical Trial
Hospital Universitari Vall d'Hebron Research Institute2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年7月10日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Increase in the percentage of Treg cells
研究概览
简要总结
It is a randomized, double-blind, placebo-controlled clinical trial whose general objective of this study is to determine the effects of probiotic administration in multiple sclerosis patients.
80 patients with relapsing-remitting multiple sclerosis will be enrolled in the study. Patients will be randomly assigned to receive either a probiotic (n=40) or a placebo (n=40) stratified by type of medication, gender and use of hormonal contraceptive treatment. They will receive a probiotic (Lactibane Iki) or placebo sachet twice a day for six months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-60 years, inclusive
- •Diagnosis of RRMS (McDonald Criteria 2024, Montalban et al)
- •Expanded disability status scale (EDSS) score less than or equal to 5.5
- •Patients receiving a first line treatment with teriflunomide, dimethyl fumarate, interferon-beta or glatiramer acetate at a stable dose, for at least 24 weeks, or patients who are not receiving treatment because they do not want to receive a disease modifying therapy after the investigator has informed them of their possible respective benefits and possible adverse events
- •Not active RRMS patients (Lubin et al, 2014) for whom a switch in background therapy is not anticipated, based on the Investigator's judgment.
- •At enrollment, the patient is not expected to require a change in DMT
- •Females of childbearing potential must have a negative urine pregnancy test result prior to initiation of study product
- •For females of childbearing potential: agreement to use adequate contraceptive methods during the treatment period
- •Ability to comply with the study protocol
- •Patients must sign and date a written informed consent prior to entering the study
排除标准
- •Relapse the month before enrollment
- •Use of corticosteroids the month before enrollment
- •Use of antibiotics three months before enrollment
- •Taking other forms of symbiotic, probiotic, prebiotic and postbiotic supplements three months before enrollment
- •Patients suffering from any type of bowel disease
- •Pregnant or breastfeeding or intending to become pregnant during the study.
研究组 & 干预措施
Lactibane Iki
Experimental
干预措施: Lactibane Iki (Dietary Supplement)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Increase in the percentage of Treg cells
时间窗: 6 months
Increase in the percentage of Treg cells
时间窗: 6 months
次要结局
- Immunological profile (percentage of positive cells): Th1 cells; Th17cells; Breg cells; DCs(6 months)
- Serum levels of NfL, GFAP, cytokines and CRP(6 months)
- Serum and fecal levels of SCFAs(6 months)
- Microbiota composition analysis(6 months)
- Immunological profile (percentage of positive cells): Th1 cells; Th17cells; Breg cells; DCs(6 months)
- Serum levels of NfL, GFAP, cytokines and CRP(6 months)
- Serum and fecal levels of SCFAs(6 months)
- Microbiota composition analysis(6 months)
研究者
研究点 (2)
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