ACTRN12614001077651已完成未知
Assessing actigraphic sleep efficiency, Profile of Mood States and Rapid Visual Information Processing for antibiotic and probiotic treatment to reduce gut dysbiosis in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome patients with high Streptococcus: Comparison between sexes.
CFS Discovery Clinic0 个研究点目标入组 40 人开始时间: 2014年10月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •Participants will be patients who have voluntarily presented or been referred to CFSDC. Prospective participants will be:
- •- aged above 18 years
- •- meet the CCC diagnostic criteria for CFS (Carruthers et al., 2003). The CCC is more commonly used to make a diagnosis of ME/CFS in clinical practice.
- •- have higher than normal Streptococcus bacteria count levels as indicated by pathology testing (Bioscreen FMA). High levels of Streptococcus are determined by a viable count reference range above 3.00 x 10(exponent 5) cfu/gm and greater than 5% distribution within aerobic microorganisms. Normal levels are below the aforementioned count and distribution levels.
- •- refrain from taking any other antibiotics for 4 weeks prior and throughout the study period.
- •- refrain from taking any other probiotics for 2 weeks prior and throughout the study period.
- •- agree to refrain from substantially altering their current diet and intake of prescription medication or over-the-counter supplements throughout the 6 week study period - or notify the researchers of any changes required at the time of the change.
- •We will be recruiting equal proportions of male (n = 20) and female (n = 20) participants to evaluate sex-specific treatment responses.
排除标准
- •Exclusion criteria are individuals with known adverse reactions to antibiotic/probiotic treatment, concurrent contraindicative medication, or significant comorbid physical or psychiatric illnesses that prevent appropriate completion of the study.
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