ACTRN12615001351505已完成未知
A randomized double-blind placebo-controlled trial of gut microbiome transfer for the treatment of obesity in adolescents.
niversity of Auckland0 个研究点目标入组 87 人开始时间: 2015年12月14日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 87
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 14 Years 至 18 Years（—）
- 性别
- All
入选标准
- •Recipient subjects (40 males and 40 females):
- •Age 14-18 years
- •Obese (BMI: greater or equal than 30 kg/m2)
- •Post-pubertal (Tanner stage 5)
- •Gut microbiome donors:
- •Age 18-28 years
- •BMI greater than 18.5 kg/m2 and less than 30.0 kg/m2
- •Total body fat percentage: less than or equal to 29% for females; less than or equal to 19% for males
- •Regular exercise (moderate to vigorous physical activity for at least 3.5 hours/week)
- •Regular Bowel Habit (at least 1 every 2 days)
- •Intake greater than or equal to 4 portions of fruit and/or vegetables per day
排除标准
- •Any transmissible viral or bacterial pathogens, or intestinal parasites
- •Multidrug-resistant organisms (e.g. vancomycin-resistant enterococci, extended-spectrum beta-lactamase-producing Enterobacteriaceae, and carbapenem-resistant Enterobacteriaceae)
- •Gastrointestinal disease (including symptoms of irritable bowel syndrome, inflammatory bowel disease, or coeliac disease)
- •Atopic diseases requiring regular prophylaxis or treatment
- •Current or past history of malignancy
- •Impaired fasting glucose or impaired glucose tolerance
- •Type 1 diabetes, type 2 diabetes, or monogenic diabetes
- •Known dyslipidaemia, hypertension, or metabolic syndrome
- •Regular use of medications known to influence metabolism or the gut microbiome
- •Use of oral antibiotics in the past three months
- •Regular 'binge drinking', i.e. consumption of 5 or more standard drinks of alcohol per session, at least once a week
- •Any use of recreational drugs or tobacco
- •Current or past pregnancy
- •Overseas travel in previous 6 months, except for visits to Australia, UK, USA, Canada, Northern Europe, France, and Germany.
- •UK residence in 1980–1996 (due to risk of variant Creutzfeldt-Jakob disease)
- •Recipients:
- •Gastrointestinal disease (including inflammatory bowel disease or coeliac disease)
- •Use of regular medications that may influence weight, metabolism, or the gut microbiome (including oral oestrogen-containing contraceptives, antidepressants, glucose-lowering drugs, diet drugs, as well as inhaled, topical, or oral steroids)
- •Consumption of probiotics
- •Type 1 diabetes, type 2 diabetes, or monogenic diabetes
- •Chronic diseases that could affect the primary outcome (other than obesity-related conditions)
- •Food allergies
- •Allergy to macrogol (active ingredient in the bowel preparation product)
- •Allergy to any over-the-counter medication
- •No antibiotic usage for three months prior to trial treatment
研究者
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