The Use of Directed Probiotics in ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- level of CRP (C-reactive protein)
研究概览
简要总结
This clinical study aims to evaluate the use of i3.1 probiotic in participants who meet the Institute of Medicine (Canadian Consensus Criteria) case definition for ME/CFS and who may or may not be diagnosed with irritable bowel syndrome (IBS). The main questions it aims to answer are:
- how effective is the usage of the i3.1 probiotic to reduce gastrointestinal (GI) inflammation and normalize the GI and systemic/brain interface?
- how well is it working on IBS severity? The study sample is 100 male and female participants aged 45 to 70 years with ME/CFS (per the Canadian Consensus Criteria); one-half of the participants will have co-morbid IBS (per Rome IV criteria). Participants will receive an i3.1 or a placebo and be assessed at baseline, at eight weeks, and at 12 weeks (four weeks post-treatment completion).
详细描述
This single-site comparison study will be performed on 100 participants, 45 to 70 years of age, who meet the Institute of Medicine (Canadian Consensus Criteria) case definition for ME/CFS and who may or may not be diagnosed with the irritable bowel syndrome (IBS), according to the Rome IV criteria. In this study, we will evaluate using the i3.1 probiotic compared to placebo. This is a randomized, placebo-controlled trial with four study arms that will include 25 participants per arm: Individuals with ME/CFS with and without IBS, who will take either the active medication i3.1 or placebo.
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
- Double (Participant, Investigator)
盲法说明
Double-blinded
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •eligible if all of the following apply:
- •Meets IOM ME/CFS case definition criteria,
- •Co-morbid IBS: meets RomeIV criteria for alternating or diarrhea-predominant IBS as reported during screening (technically diagnosed by a physician),
- •Able to provide consent to study,
- •Patients of childbearing potential must practice effective contraception during the study and be willing to continue contraception for at least six months after the intervention,
- •agrees to participate in online surveys and follow-up visits.
排除标准
- •ineligible if any of the following apply:
- •Probiotics in the past eight weeks,
- •Antibiotics in the past eight weeks,
- •Pregnancy or lactating women,
- •Medical conditions including short bowel syndrome, celiac disease, biliary disease, pancreatitis, inflammatory bowel disease (Crohn's disease, ulcerative colitis), severe cardiovascular, neurological condition, or liver failure,
- •Gastrointestinal surgery within six months of study entry,
- •History of psychiatric disorder, alcohol or illicit drug abuse.
研究组 & 干预措施
Individuals with ME/CFS with IBS on active medication
Individuals with ME/CFS with IBS take Floradapt Intensive GI (another name i3.1), one high dose capsule (>3x10 to the ninth power) once daily for eight weeks.
干预措施: Floradapt Intensive GI (Drug)
Individuals with ME/CFS with IBS on placebo
Individuals with ME/CFS with IBS take a placebo, one capsule once daily for eight weeks.
干预措施: Placebo (Other)
Individuals with ME/CFS without IBS on active medication
Individuals with ME/CFS without IBS take Floradapt Intensive GI (another name i3.1), one high dose capsule (>3x10 to the ninth power) once daily for eight weeks.
干预措施: Floradapt Intensive GI (Drug)
Individuals with ME/CFS without IBS on placebo
Individuals with ME/CFS without IBS take a placebo, one capsule once daily for eight weeks.
干预措施: Placebo (Other)
结局指标
主要结局
level of CRP (C-reactive protein)
时间窗: from baseline to the eight week visit
CRP (C-reactive protein) will be measured at baseline and the eight-week visit (The Measurement of Biomarker Response)
The pro-inflammatory cytokines level e.g. IL-1, IL-6, and TNF-α
时间窗: from baseline to the eight week visit
The Measurement of Biomarker Response : cytokine panel.
The Symptom Severity Measurement [Efficacy]
时间窗: from baseline to the eight week visit
The symptom severity will be measured as a change of scores on the DePaul Symptom Questionnaire (DSQ) from baseline to eight-week visit. The severity and frequency are calculated on the Likert scale, where for severity 0 refers to symptoms not present, and 4 is for very severe, and for the frequency: 0 is for none of the time, and 4 is for all of the time. The score range is from 0 to 216. A higher score means a worse outcome (symptoms are present more often with more severity).
The Incidence of Intervention-Related Adverse Events [Safety]
时间窗: from baseline to the eight week visit
Safety will be assessed by documenting the frequency and severity of adverse events using a standardized form at each visit.
The Measurement of Biomarker Response to an Intervention in the Blood [Efficacy]
时间窗: from baseline to the eight week visit
The inflammation biomarkers panel will be measured at baseline and during the eight-week visit. Inflammation biomarkers analyses (such as zonulin, LPS (lipopolysaccharide) endotoxin, LBP (lipopolysaccharide-binding protein)
次要结局
- The Impact on the Irritable Bowel Syndrome (IBS) Severity(from baseline to the eight week)
- The IBS-related Quality of Life Measurement(from the eight week visit to the 12 week visit)